| Coverage Policy Manual | |
| Policy #: | 2002008 |
| Category: | Radiology |
| Initiated: | July 2002 |
| Last Review: | January 2024 |
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| Wireless Capsule Endoscopy as a Diagnostic Technique in Disorders of the Small Bowel, Esophagus and Colon | |
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| Description: |
The wireless capsule endoscopy uses a noninvasive device to visualize segments of the gastrointestinal (GI) tract. Patients swallow the capsule that records images of the intestinal mucosa as it passes through the gastrointestinal (GI) tract. The capsule is collected after being excreted and images interpreted.
Background
Screening for colon cancer is suboptimal in the U.S., with only 68.8% of Americans aged 50 to 75 years up-to-date with colorectal cancer screening as of 2018 (Joseph, 2020). Additionally, screening rates vary considerably by race, ethnicity, and socioeconomic status in the U.S, with highest rates of screening occurring in White Americans (71.1%) and the lowest rates of screening among Hispanic Americans (56.1%). Black Americans (70.1%), American Indian/Native Americans (62.1%), and Asian Americans/Pacific Islanders (64.8%) have lower screening rates than White Americans. These disparities seem to be associated with limited access to care, a lack of knowledge on family history, and adverse social determinants of health.
As of 2018, the mortality rate for colorectal cancer had decreased by 53% among men and by 30% in women since 1990 and 1969, respectively (Siegel, 2020). However, colorectal cancer incidence and mortality rates vary between racial and ethnic groups. Between 2012 and 2016, reported incidence rates were highest in non-Hispanic Black individuals, accounting for 45.7 per 100,000 population, and lowest in Asian/Pacific Islander individuals, accounting for 30.0 per 100,000 population. The magnitude of disparity is more evident in mortality rates. Colorectal cancer death rates in non-Hispanic Black individuals (19.0 per 100,000 population) between 2013 and 2017 were nearly 40% higher than those in non-Hispanic White individuals (13.8 per 100,000) and twice that of Asian/Pacific Islander individuals (9.5 per 100,000). Disparities have been attributed to many socioeconomic and social determinants of health, including low median family income, higher prevalence of risk factors, and lower rates of screening and likelihood of timely follow-up
Wireless capsule endoscopy is performed using the PillCam™ Given® Diagnostic Imaging System (previously called M2A®), which is a disposable imaging capsule manufactured by Given Imaging, Ltd (Norcross, GA). The capsule measures 11 by 30 mm and contains video imaging, self-illumination, and image transmission modules, as well as a battery supply that lasts up to 8 hours. The indwelling camera takes images at a rate of 2 frames per second as peristalsis carries the capsule through the gastrointestinal tract. The average transit time from ingestion to evacuation is 24 hours. The device uses wireless radio transmission to send the images to a receiving recorder device that the patient wears around the waist. This receiving device also contains some localizing antennae sensors that can roughly gauge where the image was taken over the abdomen. Images are then downloaded onto a workstation for viewing and processing.
Capsule endoscopy has been proposed as a method for identifying Crohn disease. There is no single criterion standard diagnostic test for Crohn disease; rather, diagnosis is based on a constellation of findings (Bourreille, 2009). Thus, it is difficult to determine the diagnostic characteristics of various tests used to diagnose the condition and difficult to determine a single comparator diagnostic test to CE.
The U.S. Food and Drug Administration (FDA) approved a novel magnetically maneuvered CE system (NaviCam™; AnX Robotica, Inc.) in May 2020 (Cross, 2021). This system consists of a single-use ingestible capsule and magnet linked to a physician-operated console. The capsule contains a camera that wirelessly captures images of the desired anatomy. The console allows the operator to control the motion and direction of the capsule, ensuring visualization of the entire stomach. The system is non-invasive, does not require sedation, and has a procedural time of approximately 15 to 20 minutes. The capsule leaves the body in 24 hours on average but may take as long as 2 weeks. The device is contraindicated for use in patients with gastrointestinal obstruction, stenosis, fistula, or those with dysphagia. Other contraindications include patients with cardiac pacemakers or other implantable electronic medical devices as well as pregnant women, those <22 years of age, and those with a body mass index ≥38.
Regulatory Status
Wireless Capsule Endoscopy Devices Cleared by the U.S. Food and Drug Administration (Code used: NEZ):
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Policy/ Coverage: |
Effective January 2022
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
The use of wireless capsule endoscopy meets primary coverage criteria for effectiveness and is covered in adults and children 10 years of age and older for:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of wireless capsule endoscopy does not meet member benefit certificate primary coverage criteria as a technique to evaluate other disorders, including but not limited to:
For members with contracts without primary coverage criteria, the use of wireless capsule endoscopy for the above listed indications is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
The use of the patency capsule does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, the use of the patency capsule is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Magnetic capsule endoscopy for the evaluation of patients with unexplained upper abdominal complaints or for any other indication does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, magnetic capsule endoscopy for the evaluation of patients with unexplained upper abdominal complaints or for any other indication is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
*NOTE- Charges for a capsule delivery system, including but not limited to the AGILE Patency System or AdvanCE device, and related professional services, are not separately reimbursable.
Effective Prior to January 2022
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
The use of wireless capsule endoscopy meets primary coverage criteria for effectiveness and is covered in adults and children 10 years of age and older for:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of wireless capsule endoscopy does not meet member benefit certificate primary coverage criteria as a technique to evaluate other disorders, including but not limited to:
For members with contracts without primary coverage criteria, the use of wireless capsule endoscopy for the above listed indications is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
The use of the patency capsule does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. For members with contracts without primary coverage criteria, the use of the patency capsule is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
*NOTE- Charges for a capsule delivery system, including but not limited to the AGILE Patency System or AdvanCE device, and related professional services, are not separately reimbursable.
Effective Prior to January 2021
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
The use of wireless capsule endoscopy meets primary coverage criteria for effectiveness and is covered in adults and children 10 years of age and older for:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of wireless capsule endoscopy does not meet member benefit certificate primary coverage criteria as a technique to evaluate other disorders, including but not limited to:
For members with contracts without primary coverage criteria, the use of wireless capsule endoscopy for the above listed indications is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
The use of the patency capsule does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. For members with contracts without primary coverage criteria, the use of the patency capsule is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
*NOTE- Charges for a capsule delivery system, including but not limited to the AGILE Patency System or AdvanCE device, and related professional services, are not separately reimbursable.
Effective September 2013- August 2014
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
The use of wireless capsule endoscopy meets primary coverage criteria for effectiveness and is covered in adults and children 10 years of age and older for:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of wireless capsule endoscopy does not meet member benefit certificate primary coverage criteria as a technique to evaluate other disorders, including but not limited to:
For members with contracts without primary coverage criteria, the use of wireless capsule endoscopy for the above listed indications is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
The use of the patency capsule does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. For members with contracts without primary coverage criteria, the use of the patency capsule is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
*NOTE- Charges for a capsule delivery system, including but not limited to the AGILE Patency System or AdvanCE device, and related professional services, are not separately reimbursable.
Effective Prior to September 2013
The use of wireless capsule endoscopy meets primary coverage criteria for effectiveness and is covered in adults and children 10 years of age and older for:
The use of wireless capsule endoscopy as a technique to evaluate other gastrointestinal diseases, including, but not limited to celiac sprue, irritable bowel syndrome, small bowel neoplasm or intestinal polyposis syndrome, is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, the use of wireless capsule endoscopy as a technique to evaluate other gastrointestinal diseases, including, but not limited to celiac sprue, irritable bowel syndrome, small bowel neoplasm or intestinal polyposis syndrome, is considered investigational. Investigational services are an exclusion in the member certificate of coverage.
Charges for a capsule delivery system, including but not limited to the AGILE Patency System or AdvanCE device, and related professional services, are not separately reimbursable.
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| Rationale: |
Obscure GI Bleeding
Obscure gastrointestinal (GI) bleeding is defined as bleeding from the GI tract that persists or recurs without an obvious etiology after imaging with upper and lower endoscopy and radiologic evaluation of the small bowel. Obscure GI bleeding is often detected by fecal occult blood testing performed for colon cancer screening, and the presence of anemia consistent with persistent blood loss (Raju, 2007). Without anemia, further testing beyond upper and lower endoscopy is not warranted. Most obscure GI bleeding is due to lesions in the esophagus, stomach, and colon; 5% are due to lesions in the small intestine. Causes of obscure bleeding in the small intestine include angiodysplasia (70–80%), tumor (5–10%), and other causes (10–25%) including those related to medication, infections (tuberculosis), Crohn’s disease, Meckel’s diverticulum, Zollinger-Ellison, vasculitis, radiation enteritis, jejunal diverticula, and chronic mesenteric ischemia (Zuckerman, 2000). In patients older than age 60 years, angiodysplasia is the most likely cause, while in those younger than age 50 years, a small bowel tumor would be the most likely cause of bleeding (Lewis, 2000).
A 2007 position statement by the American Gastroenterological Association (AGA) states that capsule endoscopy should be the third test after upper and lower endoscopy in the evaluation of obscure GI bleeding (Raju, 2007a). Evidence cited in the accompanying technical review caused them to revise prior position statements in which other tests, such as bleeding scans, angiography, repeat endoscopy, enteroscopy, and enteroclysis were recommended, depending on the presence or absence of active bleeding (Raju, 2007b). The arguments supporting the utility of capsule endoscopy are based on several lines of evidence. Capsule endoscopy appears to have higher sensitivity of locating bleeding lesions compared to other diagnostic techniques, when diagnostic yields are compared. The technical review summarizes 10 studies in which capsule endoscopy was compared with push enteroscopy in the same patients. Capsule endoscopy located a source of bleeding in between 25-55% more patients than push enteroscopy (2007b). One study by Hartmann et al. compared the findings of capsule endoscopy to what might be considered the gold standard for localizing bleeding, intraoperative endoscopy (Hartmann, 2005). Capsule endoscopy was 95% sensitive in locating bleeding and was able to localize bleeding in a few cases in which intraoperative endoscopy was not able to. In a study by Pennazio et al. in which long-term follow-up was used as the reference standard, capsule endoscopy was 89% sensitive and 95% specific in 56 patients in whom a confirmed diagnosis was obtained (Pennazio, 2004). A “true” reference standard for obscure GI bleeding is, in fact, difficult or impossible to achieve, as the bleeding source may resolve and invasive techniques such as surgery cannot be justifiably used.
A 2012 systematic review and meta-analysis by Koulaouzidis et al. evaluated 24 studies on capsule endoscopy performed after negative findings on previous diagnostic evaluations including upper and lower endoscopy (Koulaouzidis, 2012). Included in the studies were a total of 1,960 patients of which 1,194 (60.9%) had iron-deficiency anemia. The pooled per-patient diagnostic yield of all 24 studies, evaluated by a random-effects model, was 47% (95% confidence interval [CI]: 42-52%). Almost 50% of the diagnostic yield was for small bowel angioectasia. In a subset of 4 studies focused only on patients with iron-deficiency anemia (n=264, 13.47%), the pooled diagnostic yield with capsule endoscopy was 66.6% (95% CI: 61.0-72.3%) and included more vascular, inflammatory and mass/tumor lesions.
In 2012, Leung and colleagues reported on 60 consecutive patients with acute melena or hematochezia who were randomized to receive either immediate capsule endoscopy or mesenteric angiography in a 1:1 ratio after nondiagnostic endoscopy and colonoscopy (Leung, 2012). Capsule endoscopy had a significantly higher diagnostic yield than angiography (53.3% vs. 20.0%, p=0.016). The cumulative risk of re-bleeding in the angiography and capsule endoscopy group was 33.3% and 16.7%, respectively (p=0.10, log-rank test). After a mean follow-up of 48.5 months, further transfusion, hospitalization for re-bleeding, and mortality were not significantly different between the two groups.
Section Summary. There are a large number of uncontrolled studies that evaluate the use of capsule endoscopy in the evaluation of patients with occult GI bleeding. These studies are consistent in reporting that a substantial proportion of patients receive a definitive diagnosis following this test when there are few if any other diagnostic options. A meta-analysis of 24 studies estimated that the diagnostic yield in this patient population was approximately half of the included patients, and was higher in patients with documented iron-deficiency anemia.
Acute Upper GI Bleeding
Three 2013 studies with small cohorts of patients (n=25-83) have reported on the use of capsule endoscopy before upper endoscopy for acute GI bleeding, in order to triage and/or risk-stratify patients in the emergency department or hospital (Gutkin, 2013; Chandran, 2013; Gralnek, 2013). The studies report that capsule endoscopy provides useful information, such as identifying gross bleeding, inflammatory lesions, in a substantial proportion of patients and in stratifying patients into high- or low-risk categories. However, the yield of capsule endoscopy in localizing the bleeding source was lower than for esophagogastroduodenoscopy, which is the standard initial evaluation for acute upper GI bleeding. For this reason, it is unlikely that capsule endoscopy can take the place of upper endoscopy for initial evaluation of acute upper GI bleeding. Controlled studies are needed to further assess the impact of capsule endoscopy on health outcomes compared to standard management.
Suspected Crohn’s Disease
Crohn’s disease is an inflammatory disease of the small intestine. It is usually diagnosed with small bowel imaging studies and ileocolonoscopy. When these studies are negative or equivocal, capsule endoscopy has been proposed as a method for identifying Crohn’s disease. However, there is no single gold standard diagnostic test for Crohn’s disease; the diagnosis is based on a constellation of findings. Thus it is difficult to determine the diagnostic characteristics of various tests used to diagnose the condition and difficult to determine a single comparator diagnostic test to capsule endoscopy. An international consensus from 2009 stated that there are no validated diagnostic criteria for interpreting capsule endoscopy for a diagnosis of Crohn’s disease, thus, possibly explaining the variability of the diagnostic performance of capsule endoscopy (Bourreille, 2009).
Nonetheless, despite the difficulties in evaluating the clinical value of capsule endoscopy in assessing suspected Crohn’s disease, findings tend to indicate that, compared with other diagnostic modalities, capsule endoscopy has an equivalent or higher yield of positive findings. An international consensus statement found 7 studies comparing capsule endoscopy to small-bowel follow-through (SBFT), 1 study comparing capsule endoscopy to magnetic resonance imaging (MRI), and 4 studies comparing capsule endoscopy to computed tomography (CT) scan (Bourreille, 2009). The conclusion statements stated that capsule endoscopy may be superior to these alternative diagnostic tests.
The role of capsule endoscopy in established Crohn’s disease is less certain. An international consensus statement states that radiographic imaging should take precedence over capsule endoscopy because of the capability to detect obstructive strictures, extraluminal and transmural disease (Bourreille, 2009). The consensus statement identifies some studies in which capsule endoscopy had a higher percentage of positive findings than alternative tests in patients with established Crohn’s disease, but it is not clear how these findings correlated with either symptoms or the outcome of therapeutic intervention.
Section summary. For patients with suspected Crohn’s disease of the small bowel who are unable to be diagnosed by other modalities, capsule endoscopy can confirm the diagnosis in a substantial number of patients. The diagnostic yield in the available studies is variable, but is likely superior to alternative tests such as CT or MRI scanning. The evidence on monitoring of Crohn’s disease is less definitive, and it may not perform as well as other modalities for diagnosing complications of Crohn’s disease.
Ulcerative Colitis
Ulcerative colitis is an inflammatory disease of the large intestine. It is usually diagnosed with colonoscopy and biopsy. Capsule endoscopy has been proposed as an alternative method for assessing the extent and severity of disease activity in known ulcerative colitis. Sung and colleagues evaluated 100 patients with suspected or known ulcerative colitis using capsule endoscopy and colonoscopy performed on the same day (Sung, 2012). The authors reported capsule endoscopy sensitivity and specificity to detect active colonic inflammation was 89% (95% CI: 80–95) and 75% (95% CI: 51-90), respectively. The positive and negative predictive values were 93% (95% CI: 84-97) and 65% (95% CI: 43-83), respectively. It does not appear to be an adequate alternative method of assessing disease activity.
Suspected Celiac Disease
Celiac disease or gluten-sensitive enteropathy, is an immune-mediated condition of the small intestine. Serologic markers of the disease have good sensitivity and specificity, but the gold standard for diagnosis of celiac disease is obtained through small-bowel biopsies obtained during endoscopy. Capsule endoscopy has been evaluated as an alternative method of diagnosing celiac disease or in assessing the extent of disease to improve management of patients.
A meta-analysis by El-Matary et al. compared the diagnostic performance of capsule endoscopy to a reference standard of duodenal biopsy (El-Matary, 2009). The pooled analysis of 3 studies showed a sensitivity of 83% and a specificity of 98%. Another meta-analysis by Rokkas and Niv also compared the diagnostic performance of capsule endoscopy to biopsy, summarizing 6 studies that evaluated a total of 166 subjects (Rokkas, 2012). The overall pooled sensitivity was 89% and the specificity was 95%. Capsule endoscopy was able to detect involvement of intestines beyond the duodenum; however, the clinical significance of detecting further extent of celiac disease is uncertain. Given the less than 90% sensitivity of capsule endoscopy for celiac disease, it does not appear to be an adequate alternative method of making an initial diagnosis.
The role of capsule endoscopy in unconfirmed, nonresponsive or established celiac disease has little evidence to assess. One study evaluated 47 patients with complicated celiac disease and found unexpected additional findings in 60% of patients, most of which were ulcerations (Culliford, 2005). However, the definition of “complicated” celiac disease included other factors such as evidence of blood loss, itself an indication for capsule endoscopy. The impact on patient management and outcomes is unclear.
In a 2013 study by Kurien and colleagues, 62 patients with an equivocal diagnosis of celiac disease and 69 patients with confirmed celiac disease who were unresponsive to standard treatment were evaluated with capsule endoscopy (Kurien, 2013). Results were combined with HLA typing and response to gluten challenge, with the final diagnosis made by 3 expert physicians who were provided with the information from all 3 sources. The main outcome was the increase in diagnostic yield after capsule endoscopy combined with the other tests. The diagnostic yield was greatest in cases with anti-body negative villous atrophy where a diagnosis of celiac disease (or Crohn’s disease) was made in 9 of 32 patients (28%). In 8 of the 69 (12%) nonresponsive celiac disease patients, capsule endoscopy identified two cases of enteropathy-associated lymphoma, four type 1 refractory disease cases, one fibroepithelial polyp, and one case of ulcerative jejunitis. This study is limited by the lack of control groups and small sample size, in addition to the use of other tests in conjunction with capsule endoscopy for the ascertainment of a final diagnosis.
Section summary. In cases where the diagnosis of celiac disease is equivocal, capsule endoscopy can sometimes uncover morphologic changes in the small bowel consistent with celiac disease. However, it is unlikely that the appearance of small bowel on capsule endoscopy is itself sufficient to make a definitive diagnosis of celiac disease. Small bowel biopsy, celiac serologies, and HLA typing remain the standard tests for confirming celiac disease, and have a higher sensitivity and specificity for this purpose.
Esophageal Conditions
Capsule endoscopy has the capability of visualizing several types of esophageal conditions. It could potentially substitute for traditional upper endoscopy for several indications and may have an advantage of comfort and convenience. However, interventional procedures and biopsies cannot be performed.
Most studies have shown that capsule endoscopy has inferior diagnostic characteristics compared to traditional upper endoscopy for a variety of esophageal conditions. A meta-analysis of 9 studies comparing capsule endoscopy to traditional endoscopy for detecting esophageal varices calculated a sensitivity of 83% and specificity of 85% (Guturu, 2011). Another meta-analysis of 9 studies comparing capsule endoscopy to traditional endoscopy for detecting Barrett’s esophagus showed a sensitivity and specificity of 77% and 86%, respectively (Bhardwaj, 2009). The sensitivity of the test is not good enough to substitute for endoscopy.
Colon Cancer Screening
Capsule endoscopy has been investigated as a method of colon cancer screening. The test may detect precancerous polyps or actual cancer. Several studies have assessed the accuracy of capsule endoscopy for detection of colonic lesions. In the largest study of 328 patients, the sensitivity of capsule endoscopy was 64% for polyps 6 mm or larger, 73% for advanced adenoma, and 74% for cancer (Van Gossum, 2009). Other smaller studies show the sensitivity of capsule endoscopy for various types of lesions to be less than 80% (Eliakim, 2006; Schoofs, 2006; Pilz, 2010). A meta-analysis by Spada et al. of 8 studies enrolling 837 patients showed a sensitivity of 71% for polyps of any size and a specificity of 75% (Spada, 2010). Almost all the existing studies evaluating capsule endoscopy for detecting colonic lesions have been done on patients with a clinical indication for colonoscopy rather than a screening population. Based on the low sensitivity for colonic polyps, capsule endoscopy is unlikely to be an effective screening test for colon cancer unless it is repeated more frequently than colonoscopy. The specificity of the test is not optimal either, meaning that patients will undergo unnecessary follow-up colonoscopy.
Hereditary GI Polyposis Syndromes
Persons with familial adenomatous polyposis and Peutz-Jeghers syndrome are at genetically high risk of small bowel polyps and tumors. Mata and colleagues studied the role of capsule endoscopy in 24 patients with hereditary GI polyposis syndromes, including familial adenomatous polyposis (n=20) or Peutz-Jeghers syndrome (n=4) (Mata, 2005). Compared to barium studies using small bowel enteroclysis, capsule endoscopy identified 4 additional patients with small bowel polyps, which were subsequently removed with endoscopic polypectomy. Another study by Brown et al. in 19 patients showed a greater number of polyps identified with capsule endoscopy than with barium follow-through examinations (Brown, 2006). Although these studies are small, they demonstrate that capsule endoscopy can identify additional lesions in persons with disease syndromes at high risk for such lesions.
There is a small amount of evidence on use of capsule endoscopy for small bowel screening in Lynch syndrome (Koornstra, 2012). These data are insufficient to determine the prevalence and/or natural history of small bowel polyps in patients with Lynch syndrome. In addition, surveillance of the small bowel is not generally recommended as a routine intervention for patients with Lynch syndrome. For this reason, it is not possible to determine whether capsule endoscopy improves outcomes for patients with Lynch syndrome.
Patency Capsule
Contraindications to the use of capsule endoscopy include; known or suspected obstruction or stricture, Zenker’s diverticulum, intestinal pseudo-obstruction and motility disorders. Certain patients with known or suspected strictures of the small bowel may be at risk of retaining the capsule. Surgical removal may be necessary. There are limited data on the performance of the patency capsules proposed as a technique to evaluate patients with known or suspected strictures prior to using the wireless capsule endoscopy system. The capsule could be used either to eliminate certain patients who are considered low risk for capsule retention to further increase the safety of capsule endoscopy or to select patients at high risk for capsule retention who would otherwise not undergo capsule endoscopy. In either scenario, it needs to be determined whether the change in diagnostic strategy and ultimate treatment was ultimately improved as a consequence of either being selected or de-selected to have a capsule endoscopy.
These improvements would need to be weighed against any complications due to the use of the patency capsule. The published studies are small and do not provide comparative data about the incremental value of this capsule over standard clinical evaluation. Also, in some series, administration of the patency capsule has produced symptoms requiring hospitalization and even surgery. In a series from Europe, Delvaux et al. reported on findings in 22 patients with suspected intestinal stricture, 15 of whom had Crohn’s disease (Delvaux, 2005). In this study, at 30 hours after ingestion, the patency capsule was detected in 17 patients (72.3 %). In all patients in whom the capsule was blocked in the small intestine, the stenosis had been suspected on computed tomography (CT) scan or small-bowel follow-through. In 3 patients, the delay in progression of the patency capsule led to cancellation of capsule endoscopy. In 3 patients, the patency capsule induced a symptomatic intestinal occlusion, which resolved spontaneously in 1 and required emergency surgery in 2. The authors commented that the current technical development of the patency capsule limits its use in clinical practice, as it did not detect stenoses undiagnosed by CT or small-bowel follow-through, and the start of dissolution at 40 hours after ingestion is too slow to prevent episodes of intestinal occlusion. They also comment that a careful interview eliciting the patient's history and symptoms remains the most useful indicator with regard to suspicion of an intestinal stenosis. In another study from Europe, Spada et al. reported on findings in 27 patients, 24 with Crohn’s disease (Spada, 2007). In this study, 25 patients (92.6%) retrieved the patency capsule in the stools. Six patients complained of abdominal pain, 4 of whom excreted a nonintact capsule, and hospitalization was required in 1 patient due to occlusive syndrome.
Several studies show that patients who had uncomplicated passage of the patency capsule subsequently underwent uncomplicated capsule endoscopy (Herrerias, 2008; Postgate, 2008; Banerjee, 2007). These patients often had significant findings on capsule endoscopy (Herrerias, 2008; Postgate, 2008). However, it is difficult to determine whether the findings of capsule endoscopy in these patients improved their outcomes beyond any alternate test regimen that could have been done. In 1 of these studies, 3 of 106 patients had severe adverse events, including 1 patient who required surgery (Herrerias, 2008). The overall balance of harm and benefit of using the patency capsule cannot be determined from the existing studies.
Ongoing Clinical Trials
A search of online site ClinicalTrials.gov on July 15, 2013 identified 2 active randomized clinical trials on wireless capsule endoscopy. In NCT00694954, capsule endoscopy will be compared to the standard of care for suspected occult/obscure intestinal bleeding in patients with iron deficiency anemia after negative gastroscopy and colonoscopy. In NCT 01557101, adherence to screening recommendations in patients with first-degree relatives with colorectal cancer will be compared in colon capsule endoscopy versus optical colonoscopy. Capsule endoscopy is being evaluated for assessment of acute upper gastrointestinal hemorrhage in the emergency department in NCT01371591.
Summary
Wireless capsule is a device that allows visualization of intestinal mucosa that is not accessible by traditional upper or lower endoscopy. It has been most extensively studied in patients with obscure gastrointestinal (GI) tract bleeding. For this population, the evidence demonstrates that capsule endoscopy can identify a bleeding source in a substantial number of patients who are unable to be diagnosed by other methods, with a low incidence of adverse events. Since there are no other options for diagnosing obscure small bowel bleeding in patients who have negative upper and lower endoscopy, this technique will likely improve health outcomes by directing specific treatment when a bleeding source is identified. Therefore wireless capsule endoscopy may be considered medically necessary for the evaluation of obscure GI bleeding.
Similarly, for patients with suspected small bowel Crohn’s disease and for patients with familial polyposis syndromes who require surveillance of the small bowel, other methods are not available for visualizing the small bowel. Although the performance characteristics of the capsule for these indications are uncertain, it is likely to improve health outcomes by identifying some cases of these disorders and directing specific treatment. Therefore, wireless capsule endoscopy may be considered medically necessary for these indications.
For other conditions, including acute upper GI bleeding, determining the extent of involvement in Crohn’s disease, ulcerative colitis, celiac disease, esophageal conditions, Lynch syndrome, colon cancer screening, and for determination of patency of the GI tract, the evidence is not sufficient to conclude that health outcomes are improved. For some of these conditions, e.g., esophageal conditions and colon cancer screening, other modalities are available that are superior to capsule endoscopy. For other conditions, e.g., determining the extent of Crohn’s disease, the accuracy of the device needs to be established prior to determining whether outcomes are improved. For these reasons, wireless capsule endoscopy is considered investigational for these indications.
Practice Guidelines and Position Statements
A 2007 position statement by the American Gastroenterological Association (AGA) (Raju, 2007) states the following concerning obscure GI bleeding and capsule endoscopy:
An international consensus panel from 2009 (Bourreille, 2009) published guidelines on the use of wireless capsule endoscopy for inflammatory bowel disease (IBD). These guidelines included the following statements about evaluation of Crohn’s disease:
European guidelines for quality assurance in colorectal cancer screening and diagnosis, originally published in 2010, indicate capsule endoscopy is not recommended for screening for colorectal cancer (Lansdorp-Vogelaar, 2012). These guidelines indicate studies have shown capsule endoscopy to be inferior to colonoscopy in diagnostic performance.
2014 Update
A literature search was conducted using the MEDLINE database through August 2014. The following is a summary of the key identified literature.
Crohn Disease
A 2013 European consensus statement indicates MR enterography or CT enterography is usually preferable to capsule endoscopy in known Crohn disease patients (Annese, 2013). The 2013 consensus also indicates capsule endoscopy should be limited in patients with Crohn disease to the evaluation of unexplained symptoms, unexplained iron deficiency, or obscure GI bleed after other investigations are inconclusive.
Hereditary GI Polyposis Syndromes
Urquhart et al compared capsule endoscopy with magnetic resonance enterography (MRE) in 20 patients with Peutz-Jeghers syndrome (Urquhart, 2014). Capsule endoscopy identified more polyps 10 mm or larger than MRE (47 vs 14 polyps, respectively; p=0.02). However, subsequent balloon enteroscopy in 12 patients showed poor correlation of findings between techniques with a 100% positive predictive value of finding a polyp on balloon enteroscopy with MRE versus 60% for capsule endoscopy. Although these studies are small, they demonstrate that capsule endoscopy can identify additional lesions in persons with disease syndromes at high risk for such lesions.
Portal Hypertensive Enteropathy
Patients with liver cirrhosis and portal hypertension can develop portal hypertensive enteropathy, which may lead to GI bleeding. Capsule endoscopy has been considered as a diagnostic tool for portal hypertensive enteropathy. Jeon et al evaluated capsule endoscopy registry data on 45 patients with cirrhosis and portal hypertension (Jeon, 2014). Capsule endoscopy identified angiodysplasias and varices in 55.7% and 38.9% of portal hypertensive enteropathy patients (n=18) versus 7.4% and 0% in patients without portal hypertensive enteropathy (n=27), respectively (p=0.001 in both). Active bleeding was not significantly different but was found in 16.6% of portal hypertensive enteropathy patients versus 3.7% of patients without portal hypertensive enteropathy. Data are not available to determine whether capsule endoscopy evaluation of cirrhosis patients with portal hypertension lead to management changes that improve health outcomes.
Unexplained Chronic Abdominal Pain
Capsule endoscopy has been proposed as a diagnostic tool for unexplained chronic abdominal pain. Xue et al reported on a systematic review of 21 studies (N=1520) evaluating capsule endoscopy for unexplained chronic abdominal pain (Xue, 2014). The pooled diagnostic yield was 20.9% (95% CI, 15.9% to 25.9%). The most commonly identified findings were inflammatory lesions (78.3%) and tumors (9.0%). The studies in the review were highly heterogeneous. Limitations in interpreting the findings included retrospective study design, different durations of abdominal pain, and use of different tests before capsule endoscopy.
In another study that was not included in the systematic review, Yang et al reported on 243 patients evaluated with capsule endoscopy for unexplained chronic abdominal pain (Yang, 2014). The diagnostic yield of capsule endoscopy was 23.0%. Identified findings included 19 (7.8%) patients with Crohn disease, 15 (6.2%) with enteritis, 11 (4.5%) with idiopathic intestinal lymphangiectasia, 5 (2.1%) with uncinariasis, 5 (2.1%) with abnormal transit time and other findings such as small bowel tumor, ascariasis, and anaphylactoid purpura. While capsule endoscopy may yield a diagnosis for unexplained chronic abdominal pain, the accuracy of the findings is unclear. Additionally, the sequence and chronology of testing and treatment recommended before capsule endoscopy needs to be defined. Therefore, the current evidence is insufficient to determine whether capsule endoscopy is necessary to alter a course of treatment for unexplained chronic abdominal pain to improve health outcomes.
2015 Update
A literature search conducted through August 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Colon Cancer Screening
Capsule endoscopy has been investigated as a method of colon cancer screening. The test may detect precancerous polyps or actual cancer. Several studies have assessed the accuracy of capsule endoscopy for detection of colonic lesions. In the largest study identified, 884 patients with average risk for colon cancer were enrolled (Rex, 2015). All patients underwent capsule endoscopy followed by optical colonoscopy several weeks later. There were a high number of exclusions from analysis (189/885 [21% of total]) due to inadequate cleansing, colon transit time less than 40 minutes, site termination, and patient lost to follow-up. For detecting any polyps greater than 6 mm, capsule colonoscopy had an 81% sensitivity (95% CI, 77% to 84%) and a 93% specificity (95% CI, 91% to 95%), when optical colonoscopy was used as the gold standard. For polyps greater than 10 mm, the sensitivity was 80% (95% CI, 76% to
84%) and the specificity was 97% (95% CI, 96% to 98%).
Portal Hypertensive Enteropathy
Patients with liver cirrhosis and portal hypertension can develop portal hypertensive enteropathy, which may lead to GI bleeding. Capsule endoscopy has been considered as a diagnostic tool for portal hypertensive enteropathy. A Cochrane Collaboration systematic review on the use of capsule endoscopy for the diagnosis of esophageal varices was published in 2015 (Colli, 2014). This analysis included 16 studies of adults with cirrhosis. All patients underwent capsule endoscopy followed by esophagogastroduodenoscopy. Most of the studies were judged to be at high risk for bias. On pooled analysis, the sensitivity of capsule endoscopy was 84.8% (95% CI, 77.3 to 90.2) and the specificity was 84.3% (95% CI, 73.1 to 91.4). A subset analysis of studies that were at low risk for bias reported a sensitivity of 79.7% (95% CI, 73.1% to 85.0%) and a specificity of 86.1% (95% CI, 64.5% to 95.5%).
2017 Update
A literature search conducted through August 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
ACUTE UPPER GI TRACT BLEEDING
In 2016, Sung and colleagues reported on a prospective randomized controlled trial (RCT) to evaluate the use of capsule endoscopy in the emergency department for patients with suspected upper GI bleeding (Sung, 2016). Capsule endoscopy was used to determine whether patients would be admitted to the hospital or sent home, versus an alternative strategy of admitting all patients. Eligible patients presented with signs and/or symptoms of acute upper GI bleeding but were without hemodynamic shock or conditions likely to preclude use of the capsule endoscope. Seventy-one patients were randomized to capsule endoscopy in the emergency department (n=37), followed by monitoring for upper GI bleeding, or standard care (n=34), which included mandatory hospital admission. Seven capsule endoscopy patients with active bleeding or endoscopic findings were admitted, with the remainder discharged home. There were no deaths or morbid outcomes in either group, indicating that capsule endoscopy could result in equivalent patient outcomes with many patients safely avoiding emergency hospitalization.
Diagnosis of Crohn Disease
Choi and colleagues reported on a meta-analysis of studies on the effectiveness of capsule endoscopy compared to other diagnostic modalities in patients with small bowel CD (Choi, 2016). Reviewers selected 24 studies, which included patients with both suspected and established CD, and compared capsule endoscopy with a range of alternative diagnostic modalities, including SBFT, enteroclysis (a conventional fluoroscopic technique not widely used due to invasiveness, time-intensiveness, and associated discomfort for the patient), CT enterography, and magnetic resonance enterography (MRE). For patients with suspected CD, the diagnostic yield of capsule endoscopy (66%) was higher than that of SBFT (21.3%; weighted incremental yield [IYw], 0.44; 95% confidence interval [CI], 0.29 to 0.59, I2=30%). The diagnostic yield of capsule endoscopy was not significantly higher than that of CT enterography (72.5% for endoscopy vs 22.5% for CT enterography; IYw=0.36; 95% CI, 0.18 to 0.90; I2=68%) or that of MRE (85.7% for endoscopy vs 100% for MRE; IYw = -0.16; 95% CI, -0.63 to 0.32; I2=44%). The reference standards varied for the included studies, so quantitative data were not synthesized for diagnostic accuracy. In pooled analysis, in patients with suspected CD, the sensitivity and specificity of capsule endoscopy ranged from 89.6% to 92.0% and 100%, respectively.
D’Haens and colleagues reported on a multicenter pilot study to validate the second-generation colon capsule endoscope recordings against optical colonoscopy for evaluating colonic ulcerations in 40 patients with active CD (D’Haens, 2015). Patients with clinically and biochemically active CD who had indication for optical colonoscopy underwent colon capsule endoscopy with scoring of disease activity using the Simple Endoscopic Score for Crohn’s Disease (SES-CD) and the Crohn’s Disease Endoscopic Index of Severity (CDEIS). Colon capsule endoscopy scoring results were validated against optical colonoscopy results. For the CDEIS, agreement between the 2 modalities was high (intraclass correlation coefficient [ICC], 0.65; 95% CI, 0.43 to 0.80). For the SES-CD, agreement between the 2 modalities was moderate (ICC=0.50; 95% CI, 0.24 to 0.70). For a random subset of 20 recordings, the interobserver variability for colon capsule endoscopy readings was calculated. For the CDEIS and SES-CD, the between-reader ICCs were 0.67 (95% CI, 0.35 to 0.86) and 0.66 (95% CI, 0.32 to 0.85), respectively.
ESOPHAGEAL DISORDERS
Capsule endoscopy has the capability to visualize several types of esophageal conditions. It could substitute for traditional upper endoscopy for several indications and may have the advantage of comfort and convenience. However, interventional procedures and biopsies cannot be performed with capsule endoscopy. Capsule endoscopy could triage patients for endoscopy if either the sensitivity or the specificity is high. Traditional endoscopy could then be performed on the appropriate group to determine false positives or false negatives, having spared the group with a high PPV an endoscopy procedure.
Most studies have shown that capsule endoscopy has inferior diagnostic characteristics compared with traditional upper endoscopy for a variety of esophageal conditions. A meta-analysis of 9 studies comparing capsule endoscopy with traditional endoscopy for detecting esophageal varices calculated a sensitivity of 83% and specificity of 85% (Guturu, 2011). Another meta-analysis of 9 studies comparing capsule endoscopy with traditional endoscopy for detecting Barrett esophagus showed a sensitivity and specificity of 77% and 86%, respectively. Because neither the sensitivity nor the specificity of the test approached a high value, the test cannot substitute for traditional endoscopy nor can it be used to triage patients to endoscopy.
ONGOING AND UNPUBLISHED CLINICAL TRIALS
A search of ClinicalTrials.gov in August 2017 did not identify any ongoing or unpublished trials that would likely influence this review.
2018 Update
A literature search was conducted through August 2018. There was no new information identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Clinical Validity and Clinical Utility
Kopylov et al published a systematic review of studies on CE in the evaluation of CD (Kopylov, 2017). Reviewers included prospective studies comparing CE with MRE and/or small bowel contrast ultrasound in patients who had suspected and/or established CD. In pooled analyses of the 11 studies that included patients with established CD, the diagnostic yield of CE was similar to that of MRE (odds ratio [OR], 1.88; 95% CI, 0.53 to 1.48; I 2 =48%) and to ultrasound (OR=0.57; 95% CI, 0.27 to 1.20; I 2 =67%).
Portal Hypertensive Enteropathy
McCarty et al included 17 studies on wireless CE for identifying esophageal varices in patients with portal hypertension and had findings similar to the Cochrane review (McCarty, 2017). Studies used either the first or second-generation PillCam capsule. The investigators assessed the quality of individual studies and found that 8 studies were at high risk of bias. However, there was a low risk of bias in most studies in terms of whether an appropriate reference standard had been used. In a pooled analysis, the sensitivity and specificity of CE for diagnosing esophageal varices were 83% (95% CI, 76% to 89%) and 85% (95% CI, 75% to 91%), respectively.
COLON CANCER SCREENING
Other recent studies by Saito et al, Morgan et al, and Parodi have evaluated the diagnostic characteristics of CE, using subsequently performed colonoscopy as the reference standard. In the study by Saito et al, of 66 evaluable patients, per-patient sensitivity for detection of polyps was 94% (95% CI, 88.2% to 99.7%). In the study by Morgan et al, for lesions 10 mm or larger, sensitivity of CE was 100% (95% CI, 56.1% to 100%), with a specificity of 93.0% (95% CI, 79.9% to 98.2%). For lesions 6 mm or larger, sensitivity was 93.3% (95% CI, 66.0% to 99.7%) and the specificity was 80.0% (95% CI, 62.5% to 90.9%). Parodi et al included 177 first-degree relatives of individuals with colorectal cancer and found, for lesions 6 mm or larger, a sensitivity of 91% (95% CI, 81% to 96%) and a specificity of 88% (95% CI, 81% to 93%) (Parodi, 2017).
PRACTICE GUIDELINES AND POSITION STATEMENTS
Canadian Association of Gastroenterology
In 2017, the Canadian Association of Gastroenterology published guidelines on the use of video capsule endoscopy
(CE), which included the following consensus recommendations (majority voting for recommendation) (CAG, 2017).
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2019. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Suspected Celiac Disease
In a study by Kurien et al, 62 patients with an equivocal diagnosis of celiac disease and 69 patients with the confirmed celiac disease who were unresponsive to standard treatment were evaluated with CE (Kurien, 2013). Results were combined with human leukocyte antigen typing and response to gluten challenge, with the final diagnosis made by 3 expert physicians who received the information from all 3 sources. The main outcome was the increase in diagnostic yield after CE combined with the other tests. The diagnostic yield was greatest in cases with antibody negative villous atrophy where a diagnosis of celiac disease was made in 9 (28%) of 32 patients. In 8 (12%) of the 69 nonresponsive celiac disease patients, CE identified 2 cases of enteropathy-associated lymphoma, 4 type 1 refractory disease cases, 1 fibroepithelial polyp, and 1 case of ulcerative jejunitis. This study was limited by the small sample size and use of other tests in conjunction with CE to ascertain a final diagnosis.
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2020. No new literature was identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2020. The key identified literature is summarized below.
Bruining et al (2020) reported results from the multicenter, prospective BLINK trial comparing the diagnostic accuracy of CE compared to ileocolonoscopy (IC) and/or magnetic resonance enterography (MRE) in patients with established CD (Bruining, 2020). The per-protocol analysis included 99/158 enrolled subjects with 16 patients tested by all 3 modalities. Major reasons for exclusion from analysis included patency failure or MRE stricture and major protocol violations. The reference standard was defined as the presence or absence of inflammation as designated by the modality-specific scoring system at prospective interpretation by expert central readers. In cases of discrepant findings for any bowel segment, all modalities were reviewed and resolved by a consensus panel consisting of 3 gastroenterologists. Overall sensitivity, specificity, PPV, and NPV were 94% (95% CI, 86 to 98%), 74% (95% CI, 55 to 87%), 91% (95% CI, 82 to 96%), 83% (95% CI, 64 to 94%) for CE compared to 100% (95% CI, 95 to 100%), 22% (95% CI, 10 to 41%), 77% (95% CI, 68 to 85%), and 100% (95% CI, 54 to 100) for IC and/or MRE. Sensitivity of CE was significantly higher compared to MRE for enteric inflammation in the proximal small bowel (97% vs 71%, P=0.021) and similar in the terminal ileum and colon (P=0.500-0.625). Discrepant reads between the proximal small bowel, terminal ileum, and colon were 57%, 49%, and 81%, respectively. In the proximal small bowel, the majority consensus panel decision was agreement with CE.
Kjolhede et al reported on a systematic review and meta-analysis of the diagnostic accuracy of CE compared to colonoscopy with stratified results for polyps of any size, polyps ≥ 6mm, and polyps ≥ 10 mm (Kjolhede, 2020). Across analyzed patients in the 12 eligible studies, the indications for endoscopy included colorectal cancer screening or history of polyps or colorectal cancer (n=1200 [63.2%]), positive fecal immunochemical test (n=493 [26%]), first-degree relatives of patients with colorectal cancer (n=177 [9.3%]), or unspecified (n=28 [1.5%]). The rate of patients with an adequate bowel preparation ranged from 40% to 100%. The rates of complete CE transits ranged from 57% to 100%. The authors note that the relatively high rate of incomplete CE investigations limits the utility of CE in the colorectal cancer setting. All but 1 study was assessed to have a high risk of bias and applicability concerns for the reference standard.
Kobaek-Larsen et al reported on FOBT-positive individuals participating in a colorectal cancer screening program in Denmark (Kobaek-Larsen, 2018). The reference standard consisted of OC adjusted by any findings from all additional follow-up procedures, including repeat endoscopy due to suspected missed polyps unblinded to CE results in 53 patients, repeated OC due to inadequate bowel preparation in 8 patients, and follow-up CT colonography in 14 patients. CE completion rate was significantly lower than OC (P < 0.001), with only 50% of patients (n = 126) having complete OC and CE investigations.
Rondonotti et al reported on FOBT-positive individuals participating in a colorectal cancer screening program in Italy (Rondonotti, 2014). Unblinded colonoscopy, integrating OC, CTC, and CE results, was used as the reference standard. Investigations were completed in all patients with a PLR and NLR of 3.75 and 0.06 for CE, respectively.
Eliakim et al (2009) conducted a prospective, multicenter study evaluating CE compared to colonoscopy in individuals with known or suspected colonic disease (Eliakim, 2009). Twenty-one percent of patients had hematochezia or positive FOBT. The majority of patients were referred for OC due to personal or family history of colorectal cancer or for colorectal cancer screening. Polyps of any size were detected in 44% of patients, with 53% identified as having adenomas. Overall colon cleanliness for CE was considered adequate in 78% of patients (95% CI, 68 to 86%).
Several prospective case series describing the diagnostic yield of capsule endoscopy following incomplete colonoscopy for various indications were completed.
Hussey et al evaluated 50 patients 18 years of age and older who had an incomplete OC for reasons other than poor bowel preparation or suspected obstruction of the colonic lumen (Hussey, 2018). CCE Findings (n): normal (13), polyps (19; 7/19 significant), inflammation (1), diverticular disease (1), angiodysplasia (1), cancer (1). 7 patients with significant polyps were referred for polypectomy which detected 14 adenomas and hyperplastic polyps.
Baltes et al evaluated 81 patients 18 years and older who had an incomplete OC due to failure to reach the cecum or ileo-cecal anastomosis due to looping, bowel angulation, adhesions, and intolerance of sedation or inflammation (Baltes, 2018). Per protocol analysis: 74/81 due to 7 exclusions for technical failure. Adverse events: 1 capsule retention; 1 case of nausea and vomiting due to prep.
Nogales et al evaluated 96 patients 18 years and older who had an incomplete OC when cecal intubation was not achieved despite adequate bowel preparation (Nogales, 2017). CCE Findings (n): polyps (41; 25/41 significant), diverticula (11), colon cancer (2), angioectasia (2), solitary colonic ulcers (2). In 43/58 patients (44.8%) the new findings modified the therapeutic approach.
Negreanu et al evaluated patients who are risk for CRC who 1) refused (n=37) or failed prior OC (n=30), or 2) were unable to undergo OC because of anesthetic risk and co-morbidities (n=3) (N=70) (Negreanu, 2013). 3 were excluded due to technical failures. CCE Findings (n): polyps > 6mm (5), ≥ 3 polyps (10), multiple colonic angiomas (2), newly discovered Crohn disease (1), radiation enteritis (1), diverticulosis (17), ulcerative colitis and inflammatory pseudopolyps (1), <6 mm polyp (1). 17/23 patients with relevant lesions agreed to therapeutic interventions. 1 clinical failure (ulcerated rectal tumor) who refused OC following incomplete CE was reported. Adverse events: capsule impaction and retention (5).
Pioche et al evaluated 107 patients with an indication for OC per the recommendations of the French National Authority for Health, including symptoms or screening who had 1) colonoscopy failure due to difficult sigmoid loop or adhesions not related to stenosis or inadequate bowel cleansing (n=77) or 2) contraindication to OC with anesthesia due to cardiovascular or respiratory disease (n=30) (N=107) (Pioche, 2012). CCE Findings (n): significant polyps (20), insignificant polyps (2), diverticulosis (6), telangiectasia (1), lesions explaining symptoms (16). Adverse events: capsule retention (6). Management: Screening group (12) (endoscopic treatments [6], follow-up [5], refusal [1]); Negative findings (9/64) (OC - normal findings or nonsignificant lesions [5], adenomas [1]; CTC - normal findings [3]); Symptomatic group (24) (medical treatments [8], colectomy [1], endoscopic APC [1], follow-up [6], endoscopic treatments [7], refusal [1]).
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
A recent study by Cash et al evaluated the diagnostic characteristics of CE, using subsequently performed colonoscopy as the reference standard (Cash, 2021). The Cash et al study randomized patients to colon CE or CT colonography followed by optical colonoscopy (Cash, 2021). Data from 286 patients revealed that the proportion of enrollees with any polyp 6 mm or larger confirmed by subsequent blinded optical colonoscopy was 31.6% for colon CE versus 8.6% for CT colonography (Cash, 2021). The sensitivity and specificity of colon CE for polyps 6 mm or larger was 79.2% and 96.3%, respectively, while that of CT colonography was 26.8% and 98.9%. For polyps 10 mm or larger, the sensitivity and specificity of colon CE was 85.7% and 98.2% compared with 50% and 99.1% for CT colonography. The authors concluded that colon CE should be considered comparable or superior to CT colonography as a screening test; however, neither test was as effective as optical colonoscopy.
Denzer et al prospectively evaluated a magnetically guided gastric capsule as compared to conventional gastroscopy in 189 patients with upper abdominal complaints (eg, upper abdominal pain and/or anemia) from 2 French centers (Denzer, 2015). In this study, capsule gastroscopy was performed initially followed by conventional gastroscopy, with a maximum delay of 1 day but a minimum delay of 4 hours. For conventional gastroscopy, the examination was performed blinded initially. If results of the magnetic capsule and blinded gastroscopy differed, then a subsequent unblinded gastroscopy was performed. Biopsies were taken whenever appropriate. The combined endoscopic assessment (blinded and unblinded gastroscopy) including biopsy was used as the final gold standard. The primary outcome parameters were the accuracy and the sensitivity, specificity, and predictive values of magnetically guided capsule gastroscopy compared with the final gold standard with regard to major lesions on a per-patient and per-lesion basis. Overall, 23 major lesions were discovered in 21 patients. Capsule accuracy on a per-patient basis was 90.5% (95% CI, 85.4% to 94.3%) with a specificity of 94.1% (95% CI, 89.3% to 97.1%) and a sensitivity of 61.9% (95% CI, 38% to 82%). The PPV and NPV were 56.5% (95% CI, 34.5% to 76.8%) and 95.2% (95% CI, 90.7% to 97.9%), respectively. Similar results for these values were seen on a per-lesion basis. Of the other 168 patients, 94% had minor and mostly multiple lesions; the capsule made a correct diagnosis in 88.1% (95% CI, 82.2% to 92.6%). No complications of capsule or conventional gastroscopy were noted. Patient preference for capsule use for a future gastroscopy, if indicated, was 100%. In this first large study to evaluate magnetically guided capsule gastroscopy in patients with upper abdominal symptoms, the authors concluded that this technique was feasible in practice and clearly preferred by patients; however, further studies are needed to define its role in the clinical setting (eg, as a filter test to stratify patients to undergo conventional gastroscopy or some other role). Of note, this non-US study reported a low sensitivity with a wide CI and provided an extremely limited discussion of the types of upper abdominal complaints experienced by enrolled patients. No discussion in terms of the severity and duration of the complaints, as well as prior testing and treatment was undertaken, which makes determination of the appropriate place in therapy for magnetic CE in patients with unexplained upper abdominal complaints difficult.
Liao et al evaluated the accuracy of magnetically controlled CE as compared with conventional gastroscopy in 350 patients with upper abdominal complaints in a prospective, multicenter, blinded comparison study conducted in China (Liao, 2016). All patients underwent magnetic CE followed by conventional gastroscopy 2 hours later, without sedation. The primary outcome of the study was an evaluation of gastric focal lesions. Overall, with conventional gastroscopy as the gold standard, magnetic CE detected gastric focal lesions in the entire stomach with 90.4% sensitivity (95% CI, 84.7% to 96.1%), 94.7% specificity (95% CI, 91.9% to 97.5%), and 93.4% accuracy (95% CI, 90.83% to 96.02%). The PPV and NPV were 87.9% (95% CI, 81.7% to 94%) and 95.9% (95% CI, 93.4% to 98.4%). Similar sensitivity and specificity results were observed with magnetic CE as compared to conventional gastroscopy when detecting focal lesions in the upper or lower stomach specifically. No lesions of significance were missed by magnetic CE. Additionally, 335 (95.7%) patients preferred magnetic CE over conventional gastroscopy and only 5 patients reported an adverse event; the majority of these events were considered to be related to gastric preparation. The authors concluded that magnetic CE detects upper abdominal focal lesions with comparable accuracy to conventional gastroscopy and is a promising alternative for screening for gastric diseases; however, similar to the prior study, this non-US study provided no discussion of the types of upper abdominal complaints experienced by patients or prior tests or treatments undertaken.
The U.S. Preventive Services Task Force published its most recent recommendations for colorectal cancer screening in 2021 (Davidson, 2021). Colorectal cancer screening was recommended starting at age 50 years and continuing until age 75 years (A recommendation) and in adults aged 45 to 49 years (B recommendation). The USPSTF recommendation for screening for colorectal cancer does not include serum tests, urine tests, or CE for colorectal cancer screening because of the limited available evidence on these tests and because other effective tests are available.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
A study by Elosua et al evaluated the therapeutic impact of CE in patients with established CD in this retrospective, single-center study (Elosua, 2022). Therapeutic impact was defined as change in CD-related treatment recommended based on CE results and 305 patients (N=432 procedures) with established CD who underwent a CE procedure between January 2008 and December 2019 were included. Of the included CE procedures, 87.5% were deemed conclusive. Mild inflammation was detected in 41.6% of patients and moderate-to-severe activity was detected in 21.9% of patients. Management changes guided by CE procedures occurred in 51.3% of procedures, with 46.1% of procedures leading to treatment escalation and 5.3% of procedures leading to de-escalation. Disease activity demonstrated by CE results was correlated with therapeutic changes. Mucosal healing assessed via CE was the only independent factor that predicted therapy de-escalation (OR, 6.86; 95% CI, 1.42 to 33). The single-center group of clinicians limited heterogeneity. These results are limited by the retrospective design of the study.
In 2013, the American College of Gastroenterology (ACG) issued guidelines on the diagnosis and management of celiac disease (Rubio-Tapia, 2013). The guidelines recommended that capsule endoscopy (CE) not be used for initial diagnosis, except for patients with positive celiac-specific serology who are unwilling or unable to undergo upper endoscopy with biopsy (strong recommendation, moderate level of evidence). As of November 2022, a guideline update is in process (ACG Guidelines, 2022).
In 2021, the ACG issued guidelines on colorectal cancer screening (Shaukat, 2021). They "suggest consideration of the following screening tests for individuals unable or unwilling to undergo a colonoscopy or FIT [fecal immunochemical testing]: flexible sigmoidoscopy, multitarget stool DNA test, CT [computed tomography] colonography, or colon capsule [capsule endoscopy]" (conditional recommendation, very low quality of evidence).
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
The lifetime risk of small bowel cancer in Lynch syndrome has been estimated at 5%. Although not extremely high, this risk is greatly increased compared with the general population. There are a few case series of the prevalence of neoplastic lesions in asymptomatic patients with Lynch syndrome. 200 patients with Lynch syndrome who underwent CE were evaluated (Haanstra, 2015). Small bowel neoplasia was detected in the duodenum in 2 patients (1 adenocarcinoma, 1 adenoma). These lesions would have been in the reach of a gastroduodenoscope. In a smaller study 35 asymptomatic patients with Lynch syndrome underwent colon CE (Saurin, 2010). Small bowel neoplasms were diagnosed in 3 (8.6%) patients (1 adenocarcinoma, 2adenomas with low-grade dysplasia).
Several studies have assessed the accuracy of CE for detecting colonic lesions. A systematic review and meta-analysis reported on the diagnostic accuracy of CE for detecting colorectal polyps with stratified results for first- and second-generation capsules (Spada, 2016). Across the 14 eligible studies, the indications for endoscopy included colorectal cancer screening (n=1261 [47%]), post polypectomy surveillance or family history of colorectal cancer (n=636 [24%]), symptoms suggestive of cancer and/or fecal occult blood test positivity (n=619 [23%]), positive imaging tests (n=136 [5%]), or other indication (n=24 [1%]). There were no missed cancers (n=11) in the series using second-generation CE (per-patient sensitivity,100%). In series using the first-generation CE, 6 of 26 proven cancers were missed on CE (per-patient sensitivity, 77%).
The relevant population of interest is patients undergoing screening for colon polyps who experience an incomplete colonoscopy after adequate bowel preparation where a complete visualization of the colon was not technically possible. Factors that may contribute to incomplete colonoscopies include patient pain and discomfort, diverticulosis, tortuosity, adhesions due to prior surgeries, angulation or fixation of bowel loops, ineffective sedation, and endoscopist and technician expertise (Franco, 2017).
In 2013, the American College of Gastroenterology (ACG) issued guidelines on the diagnosis and management of celiac disease (Rubio-Tapia, 2013). The guidelines recommended that capsule endoscopy (CE) not be used for initial diagnosis, except for patients with positive celiac-specific serology who are unwilling or unable to undergo upper endoscopy with biopsy (strong recommendation, moderate level of evidence). These guidelines were updated in 2023, with no mention of CE (Rubio-Tapia, 2023).
In 2018, the ACG updated its guidelines on the management of Crohn Disease (CD)CD in adults (Lichtestein, 2018). It makes 2 recommendations specific to video capsule endoscopy:
These recommendations are based on multiple studies. Capsule endoscopy was found to be “superior to small bowel barium studies, computed tomography enterography (CTE) and ileocolonoscopy in patients with suspected CD, with incremental yield of diagnosis of 32%, 47%, and 22%, respectively….Capsule endoscopy has a high negative predictive value of 96%.”
In 2015, the ACG issued guidelines on the diagnosis and management of small bowel bleeding (including using “small bowel bleeding” to replace “obscure GI [gastrointestinal] bleeding,” which should be reserved for patients in whom a source of bleeding cannot be identified anywhere in the GI tract) (Gerson, 2015). As of November 2023, a guideline update is in progress (American College of Gastroenterology, 2023).
In tandem with the U.S. Preventative Services Task Force (USPSTF) 2021 recommendations, the Multi-Society Task Force released a focused update to these guidelines in 2021, however, no changes were made regarding CE (Patel, 2022).
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