Prospective multicenter study to evaluate capsule endoscopy competency using a validated assessment tool.

BACKGROUND AND AIMS: Capsule endoscopy (CE) is an established, noninvasive modality for examining the small bowel. Minimum training requirements are based primarily on guidelines and expert opinion. A validated tool to assess the competence of CE is lacking. In this prospective, multicenter study, we determined the minimum number of CE procedures required to achieve competence during gastroenterology fellowship; validated a capsule competency test (CapCT); and evaluated any correlation between CE competence and endoscopy experience. METHODS: We included second- and third-year gastroenterology fellows from 3 institutions between 2013 and 2018 in a structured CE training program with supervised CE interpretation. Fellows completed the CapCT with a maximal score of 100. For comparison, expert faculty completed the same CapCT. Trainee competence was defined as a score ≥90% compared with the mean expert score. Fellows were tested after 15, 25, and 35 supervised CE interpretations. CapCT was validated using expert consensus and item analysis. Data were collected on the number of previous endoscopies. RESULTS: A total of 68 trainees completed 102 CapCTs. Fourteen CE experts completed the CapCT with a mean score of 94. Mean scores for fellows after 15, 25, and 35 cases were 83, 86, and 87, respectively. Fellows with at least 25 interpretations achieved a mean score ≥84 in all 3 institutions. CapCT item analysis showed high interobserver agreement among expert faculty (k = 0.85). There was no correlation between the scores and the number of endoscopies performed. CONCLUSION: After a structured CE training program, gastroenterology fellows should complete a minimum of 25 supervised CE interpretations before assessing competence using the validated CapCT, regardless of endoscopy experience.

Capsule Endoscopy in Patients with Implantable Electromedical Devices is Safe.

Background and Study Aims. The presence of an implantable electromechanical cardiac device (IED) has long been considered a relative contraindication to the performance of video capsule endoscopy (CE). The primary aim of this study was to evaluate the safety of CE in patients with IEDs. A secondary purpose was to determine whether IEDs have any impact on images captured by CE. Patients and Methods. A retrospective chart review of all patients who had a capsule endoscopy at Mayo Clinic in Scottsdale, AZ, USA, or Rochester, MN, USA, (January 2002 to June 2010) was performed to identify CE studies done on patients with IEDs. One hundred and eighteen capsule studies performed in 108 patients with IEDs were identified and reviewed for demographic data, method of preparation, and study data. Results. The most common indications for CE were obscure gastrointestinal bleeding (77%), anemia (14%), abdominal pain (5%), celiac disease (2%), diarrhea (1%), and Crohn's disease (1%). Postprocedure assessments did not reveal any detectable alteration on the function of the IED. One patient with an ICD had a 25-minute loss of capsule imaging due to recorder defect. Two patients with LVADs had interference with capsule image acquisition. Conclusions. CE did not interfere with IED function, including PM, ICD, and/or LVAD and thus appears safe. Additionally, PM and ICD do not appear to interfere with image acquisition but LVAD may interfere with capsule images and require that capsule leads be positioned as far away as possible from the IED to assure reliable image acquisition.

Partial preparation computed tomographic colonography: a feasibility study.

We retrospectively evaluated computed tomographic colonography examinations of patients who have had a partial bowel preparation and compared the quality of their preparation with patients who have had a full bowel preparation. In total, 27 patients undergoing computed tomographic colonography examination (10 patients with partial bowel preparation and 17 with full bowel preparation) had their examinations retrospectively reviewed by three independent radiologists in a blinded manner, with evaluation of residual stool, distention, residual fluid, and overall bowel preparation quality. Six colon segments were evaluated individually and independently for these four variables (a total of 161 segments tested). Comparisons were made with the Mann-Whitney test between the partial preparation group and the full preparation group. Partial preparation included stool and fluid tagging plus 20 mg of bisacodyl orally; full preparation included stool and fluid tagging plus 2 L of polyethylene glycol solution. No significant clinical difference was found in colon preparation between the partial and full bowel preparation groups--when evaluated with individual colon segments or by independent readers. Interreader correlation was high. This pilot study indicates that full bowel preparation is not required for diagnostic-quality computed tomographic colonography examination. Further evaluation of this partial bowel preparation regimen is warranted.

Capsule endoscopy has a significantly higher diagnostic yield in patients with suspected and established small-bowel Crohn's disease: a meta-analysis.

OBJECTIVES: Capsule endoscopy (CE) has demonstrated superior performance compared with other modalities in its ability to detect early small-bowel (SB) Crohn's disease (CD), especially when ileoscopy is negative or unsuccessful. The aim of this study was to evaluate the diagnostic yield of CE compared with other modalities in patients with suspected and established CD using a meta-analysis. METHODS: A thorough literature search for prospective studies comparing the diagnostic yield of CE with other modalities in patients with CD was undertaken. Other modalities included push enteroscopy (PE), colonoscopy with ileoscopy (C+IL), SB radiography (SBR), computed tomography enterography (CTE), and magnetic resonance enterography (MRE). Data on diagnostic yield among various modalities were extracted, pooled, and analyzed. Data on patients with suspected and established CD were analyzed separately. Weighted incremental yield (IYW) (diagnostic yield of CE-diagnostic yield of comparative modality) and 95% confidence intervals (CIs) of CE over comparative modalities were calculated. RESULTS: A total of 12 trials (n=428) compared the yield of CE with SBR in patients with CD. Eight trials (n=236) compared CE with C+IL, four trials (n=119) compared CE with CTE, two trials (n=102) compared CE with PE, and four trials (n=123) compared CE with MRE. For the suspected CD subgroup, several comparisons met statistical significance. Yields in this subgroup were CE vs. SBR: 52 vs. 16% (IYw=32%, P<0.0001, 95% CI=16-48%), CE vs. CTE: 68 vs. 21% (IYw=47%, P<0.00001, 95% CI=31-63%), and CE vs. C+IL: 47 vs. 25% (IYw=22%, P=0.009, 95% CI=5-39%). Statistically significant yields for CE vs. an alternate diagnostic modality in established CD patients were seen in CE vs. PE: 66 vs. 9% (IYw=57%, P<0.00001, 95% CI=43-71%), CE vs. SBR: 71 vs. 36% (IYw=38%, P<0.00001, 95% CI=22-54%), and in CE vs. CTE: 71 vs. 39% (IYw=32%, P=or<0.0001, 95% CI=16-47%). CONCLUSIONS: Our meta-analysis demonstrates that CE is superior to SBR, CTE, and C+IL in the evaluation of suspected CD patients. CE is also a more effective diagnostic tool in established CD patients compared with SBR, CTE, and PE.

Retention of the capsule endoscope: a single-center experience of 1000 capsule endoscopy procedures.

BACKGROUND: Retention of the video capsule is the most significant complication associated with capsule endoscopy (CE). There are limited data on incidence, risk factors, and outcomes of capsule retention. OBJECTIVE: We aimed to determine the incidence of capsule retention and to investigate the causes and clinical outcomes of capsule retention. SETTING: Single tertiary referral medical center. PATIENTS: All patients who underwent CE for suspected small bowel disease from June 2002 to March 2006. METHODS: Retrospective case series. RESULTS: Capsule retention occurred in 1.4% of our patients (14/1000). Eleven patients failed to pass the capsule because of nonsteroidal anti-inflammatory drug (NSAID) enteropathy (diaphragm disease). One patient had capsule retention from an obstructing carcinoid tumor. Metastatic ovarian cancer with invasion of the ileum was the cause of retention in another patient. One patient who did not have surgical removal of the capsule because of loss of follow-up had retention caused by a small-bowel tumor suspicious for carcinoid tumor on CT enterography. All patients remained "asymptomatic" from the retained capsules. Thirteen patients underwent elective partial small-bowel resection and capsule removal. No deaths were associated with these surgeries. Eleven patients recovered promptly, whereas 2 patients had mild postoperative ileus. LIMITATION: Retrospective study. CONCLUSION: Retention of the capsule endoscope appears to be infrequent. The most common cause is diaphragm disease resulting from NSAIDs in this study population. In most cases, capsule retention is asymptomatic, and it usually leads to surgical removal, which appears safe and also identifies and treats the underlying small-bowel condition.

A single-center experience of 260 consecutive patients undergoing capsule endoscopy for obscure gastrointestinal bleeding.

OBJECTIVES: Capsule endoscopy (CE) has revolutionized the evaluation of obscure gastrointestinal bleeding (OGIB) but published literature is limited to small series with heterogeneous indications. The aim of this study was to determine the findings and the diagnostic yield of CE in a large series of patients with overt and occult OGIB. METHODS: Data on 260 patients who underwent CE for overt (N = 126) or occult (N = 134) OGIB were obtained by retrospective chart review and review of an internal database of CE patients and findings. RESULTS: Visualization of the entire small bowel was achieved in 74%. The majority of exams (66%) were rated as having a good or excellent prep. Clinically significant positive findings occurred in 53%. The yield of CE in the obscure-overt group was greater than in the obscure-occult group (60%vs 46%, P= 0.03). Small bowel angioectasias were the most common finding, comprising over 60% of clinically significant lesions. The mean follow-up was 9.6 months, and there were significant reductions in hospitalizations, additional tests/procedures, and units of blood transfused after CE. Both before and after CE, patients in the overt group had more significant GI bleeding than patients in the occult group. Complications occurred in five (1.9%) cases: nonnatural excretion (four) and CE impaction at cricopharyngeus (one). CONCLUSIONS: The yield of clinically important findings on CE in patients with OGIB is 53% and is greater in patients with obscure-overt than obscure-occult GI bleeding. Angioectasias account for the majority of significant lesions in both groups. Compared with pre-CE, patients had clinical improvement post-CE in medical interventions for OGIB. Complications of CE occur in less than 2% of cases.

A meta-analysis of the yield of capsule endoscopy compared to other diagnostic modalities in patients with non-stricturing small bowel Crohn's disease.

OBJECTIVES: Capsule endoscopy (CE) allows for direct evaluation of the small bowel mucosa in patients with Crohn's disease (CD). A number of studies have revealed significantly improved yield for CE over other modalities for the diagnosis of CD, but as sample sizes have been small, the true degree of benefit is uncertain. Additionally, it is not clear whether patients with a suspected initial presentation of CD and those with suspected recurrent disease are equally likely to benefit from CE. The aim of this study was to evaluate the yield of CE compared with other modalities in symptomatic patients with suspected or established CD using meta-analysis. METHODS: We performed a recursive literature search of prospective studies comparing the yield of CE to other modalities in patients with suspected or established CD. Data on yield among various modalities were extracted, pooled, and analyzed. Incremental yield (IY) (yield of CE--yield of comparative modality) and 95% confidence intervals (95% CI) of CE over comparative modalities were calculated. Subanalyses of patients with a suspected initial presentation of CD and those with suspected recurrent disease were also performed. RESULTS: Nine studies (n = 250) compared the yield of CE with small bowel barium radiography for the diagnosis of CD. The yield for CE versus barium radiography for all patients was 63% and 23%, respectively (IY = 40%, p < 0.001, 95% CI = 28-51%). Four trials compared the yield of CE to colonoscopy with ileoscopy (n = 114). The yield for CE versus ileoscopy for all patients was 61% and 46%, respectively (IY = 15%, p= 0.02, 95% CI = 2-27%). Three studies compared the yield of CE to computed tomography (CT) enterography/CT enteroclysis (n = 93). The yield for CE versus CT for all patients was 69% and 30%, respectively (IY = 38%, p= 0.001, 95% CI = 15-60%). Two trials compared CE to push enteroscopy (IY = 38%, p < 0.001, 95% CI = 26-50%) and one trial compared CE to small bowel magnetic resonance imaging (MRI) (IY = 22%, p= 0.16, 95% CI =-9% to 53%). Subanalysis of patients with a suspected initial presentation of CD showed no statistically significant difference between the yield of CE and barium radiography (p= 0.09), colonoscopy with ileoscopy (p= 0.48), CT enterography (p= 0.07), or push enteroscopy (p= 0.51). Subanalysis of patients with established CD with suspected small bowel recurrence revealed a statistically significant difference in yield in favor of CE compared with all other modalities (barium radiography (p < 0.001), colonoscopy with ileoscopy (p= 0.002), CT enterography (p < 0.001), and push enteroscopy (p < 0.001)). CONCLUSIONS: In study populations, CE is superior to all other modalities for diagnosing non-stricturing small bowel CD, with a number needed to test (NNT) of 3 to yield one additional diagnosis of CD over small bowel barium radiography and NNT = 7 over colonoscopy with ileoscopy. These results are due to a highly significant IY with CE over all other modalities in patients with established non-stricturing CD being evaluated for a small bowel recurrence. While there was no significant difference seen between CE and alternate modalities for diagnosing small bowel CD in patients with a suspected initial presentation of CD, the trend toward significance for a number of modalities suggests the possibility of a type II error. Larger studies are needed to better establish the role of CE for diagnosing small bowel CD in patients with a suspected initial presentation of CD.

A meta-analysis of the yield of capsule endoscopy compared to other diagnostic modalities in patients with obscure gastrointestinal bleeding.

OBJECTIVES: Due to its superior ability to examine the entire small bowel mucosa, capsule endoscopy (CE) has broadened the diagnostic evaluation of patients with obscure gastrointestinal bleeding (OGIB). Published studies have revealed a numerically superior performance of CE in determining a source of OGIB compared with other modalities, but due to small sample sizes, the overall magnitude of benefit is unknown. Additionally, the types of lesions more likely to be found by CE versus alternate modalities are also unknown. The aim of this study was to evaluate the yield of small bowel findings with CE in patients with OGIB compared to other modalities using meta-analysis. METHODS: We performed a recursive literature search of prospective studies comparing the yield of CE to other modalities in patients with OGIB. Data on yield and types of lesions identified among various modalities were extracted, pooled, and analyzed. Incremental yield (IY) (yield of CE-yield of comparative modality) and 95% confidence intervals (95% CI) of CE over comparative modalities were calculated. RESULTS: A total of 14 studies (n = 396) compared the yield of CE with push enteroscopy for OGIB. The yield for CE and push enteroscopy was 63% and 28%, respectively (IY = 35%, p < 0.00001, 95% CI = 26-43%) and for clinically significant findings (n = 376) was 56% and 26%, respectively (IY = 30%, p < 0.00001, 95% CI = 21-38%). Three studies (n = 88) compared the yield of CE to small bowel barium radiography. The yield for CE and small bowel barium radiography for any finding was 67% and 8%, respectively (IY = 59%, p < 0.00001, 95% CI = 48-70%) and for clinically significant findings was 42% and 6%, respectively (IY = 36%, p < 0.00001, 95% CI = 25-48%). Number needed to test (NNT) to yield one additional clinically significant finding with CE over either modality was 3 (95% CI = 2-4). One study each compared the yield of significant findings on CE to intraoperative enteroscopy (n = 42, IY = 0%, p= 1.0, 95% CI =-16% to 16%), computed tomography enteroclysis (n = 8, IY = 38%, p= 0.08, 95% CI =-4% to 79%), mesenteric angiogram (n = 17, IY =-6%, p= 0.73, 95% CI =-39% to 28%), and small bowel magnetic resonance imaging (n = 14, IY = 36%, p= 0.007, 95% CI = 10-62%). Ten of the 14 trials comparing CE with push enteroscopy classified the types of lesions found on examination. CE had a 36% yield for vascular lesions versus 20% for push enteroscopy, with an IY of 16% (p < 0.00001, 95% CI = 9-23%). Inflammatory lesions were also found more often in CE (11%) than in push enteroscopy (2%), with an IY of 9% (p= 0.0001, 95% CI = 5-13%). There was no significant difference in the yield of tumors or "other" findings between CE and push enteroscopy. CONCLUSIONS: CE is superior to push enteroscopy and small bowel barium radiography for diagnosing clinically significant small bowel pathology in patients with OGIB. In study populations, the IY of CE over push enteroscopy and small bowel barium radiography for clinically significant findings is >or=30% with an NNT of 3, primarily due to visualization of additional vascular and inflammatory lesions by CE.

Yield of repeat wireless video capsule endoscopy in patients with obscure gastrointestinal bleeding.

PURPOSE: Capsule endoscopy (CE) has been shown to have a high diagnostic yield in patients with obscure gastrointestinal bleeding (OGIB). It is not known if repeating CE improves diagnostic yield or changes patient management when the initial CE is negative or nondiagnostic. The aims of this study are (1) to understand the reasons for repeat CE, (2) to determine the diagnostic yield of repeat CE, and (3) to establish if findings on repeat CE resulted in a change in patient management. METHODS: Between August 2001 and October 2003, we performed 391 capsule studies. Of these, 24 were repeat studies in patients with OGIB. We retrospectively reviewed the charts of these 24 patients. RESULTS: The reasons for repeat CE were: recurrent gastrointestinal bleeding (13), limited visualization on first exam due to poor prep or blood (10), complication (1) (capsule impaction at cricopharyngeus). Eighteen of 24 (75%) repeat capsule studies revealed additional findings (7 arteriovenous malformations, 2 gastropathy, 2 erosions, 2 masses, 1 ulcer, 2 red spots, 1 linear streak, 1 erythema). These findings led to changes in patient management in 15 of the 24 (62.5%) cases. CONCLUSIONS: Indications for repeat CE most commonly include recurrent gastrointestinal bleeding and limited visualization on initial study. Repeat CE results in a high yield of new findings that lead to changes in patient management. Repeat CE should be considered in patients with persistent OGIB when the initial study is negative or inconclusive.