The Bethesda ERCP Skills Assessment Tool (BESAT) can reliably differentiate endoscopists of different experience levels.

Background and study aims The Bethesda ERCP Skill Assessment Tool (BESAT) is a video-based assessment tool of technical endoscopic retrograde cholangiopancreatography (ERCP) skill with previously established validity evidence. We aimed to assess the discriminative validity of the BESAT in differentiating ERCP skill levels. Methods Twelve experienced ERCP practitioners from tertiary academic centers were asked to blindly rate 43 ERCP videos using the BESAT. ERCP videos consisted of native biliary cannulation and sphincterotomy and were recorded from 10 unique endoscopists of various ERCP experience (from advanced endoscopy fellow to > 10 years of ERCP experience). Inter-rater reliability, discriminative validity, and internal structure validity were subsequently assessed. Results The BESAT was found to reliably differentiate between endoscopists of varying levels of ERCP experience with experienced ERCPists scoring higher than novice ERCPists in 11 of 13 (85%) instrument items. Inter-rater reliability for BESAT items ranged from good to excellent (intraclass correlation range: 0.86 to 0.93). Internal structure validity was assessed with item-total correlations ranging from 0.53 to 0.83. Conclusions Study findings demonstrate that the BESAT, a video-based ERCP skill assessment tool, has high inter-rater reliability and has discriminative validity in differentiating novice from expert ERCP skill. Further investigations are needed to determine the role of video-based assessment in improving trainee learning curves and patient outcomes.

SpHincterotomy for Acute Recurrent Pancreatitis Randomized Trial: Rationale, Methodology, and Potential Implications.

OBJECTIVES: In patients with acute recurrent pancreatitis (ARP), pancreas divisum, and no other etiologic factors, endoscopic retrograde cholangiopancreatography (ERCP) with minor papilla endoscopic sphincterotomy (miES) is often performed to enlarge the minor papillary orifice, based on limited data. The aims of this study are to describe the rationale and methodology of a sham-controlled clinical trial designed to test the hypothesis that miES reduces the risk of acute pancreatitis. METHODS: The SpHincterotomy for Acute Recurrent Pancreatitis (SHARP) trial is a multicenter, international, sham-controlled, randomized trial comparing endoscopic ultrasound + ERCP with miES versus endoscopic ultrasound + sham for the management of ARP. A total of 234 consented patients having 2 or more discrete episodes of acute pancreatitis, pancreas divisum confirmed by magnetic resonance cholangiopancreatography, and no other clear etiology for acute pancreatitis will be randomized. Both cohorts will be followed for a minimum of 6 months and a maximum of 48 months. RESULTS: The trial is powered to detect a 33% risk reduction of acute pancreatitis frequency. CONCLUSIONS: The SHARP trial will determine whether ERCP with miES benefits patients with idiopathic ARP and pancreas divisum. Trial planning has informed the importance of blinded outcome assessors and long-term follow-up.

Randomized sham-controlled trial of the 6-month swallowable gas-filled intragastric balloon system for weight loss.

BACKGROUND: Obesity is a significant health problem and additional therapies are needed to improve obesity treatment. OBJECTIVE: Determine the efficacy and safety of a 6-month swallowable gas-filled intragastric balloon system for weight loss. SETTING: Fifteen academic and private practice centers in the United States. METHODS: This was a double-blind, randomized sham-controlled trial of the swallowable gas-filled intragastric balloon system plus lifestyle therapy compared with lifestyle therapy alone for weight loss at 6 months in participants aged 22 to 60 years with body mass index 30 to 40 kg/m2, across 15 sites in the United States. The following endpoints were included: difference in percent total weight loss in treatment group versus control group was >2.1%, and a responder rate of >35% in the treatment group. RESULTS: Three hundred eighty-seven patients swallowed at least 1 capsule. Of participants, 93.3% completed all 24 weeks of blinded study testing. Nonserious adverse events occurred in 91.1% of patients, but only .4% were severe. One bleeding ulcer and 1 balloon deflation occurred. In analysis of patients who completed treatment, the treatment and control groups achieved 7.1 ± 5.0% and 3.6 ± 5.1% total weight loss, respectively, and a mean difference of 3.5% (P = .0085). Total weight loss in treatment and control groups were 7.1 ± 5.3 and 3.6 ± 5.1 kg (P < .0001), and body mass index change in the treatment and control groups were 2.5 ± 1.8 and 1.3 ± 1.8 kg/m2 (P < .0001), respectively. The responder rate in the treatment group was 66.7% (P < .0001). Weight loss maintenance in the treatment group was 88.5% at 48 weeks. CONCLUSIONS: Treatment with lifestyle therapy and the 6-month swallowable gas-filled intragastric balloon system was safe and resulted in twice as much weight loss compared with a sham control, with high weight loss maintenance at 48 weeks.

Bile cast syndrome: Diagnosis and management, a case series.

Background and study aims Bile cast syndrome (BCS) is a complication of orthotopic liver transplantation (OLT). It occurs in 4 % to 18 % of OLT recipients and can present as cholangitis and graft damage or loss. Twenty-two percent of patients with BCS require repeat OLT. The diagnosis and management of BCS can be challenging. Our aim is to share our experience with BCS and to briefly review the diagnosis and management of the condition.

ASGE Bariatric Endoscopy Task Force systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting endoscopic bariatric therapies.

The increasing global burden of obesity and its associated comorbidities has created an urgent need for additional treatment options to fight this pandemic. Endoscopic bariatric therapies (EBTs) provide an effective and minimally invasive treatment approach to obesity that would increase treatment options beyond surgery, medications, and lifestyle measures. This systematic review and meta-analysis were performed by the American Society for Gastrointestinal Endoscopy (ASGE) Bariatric Endoscopy Task Force comprising experts in the subject area and the ASGE Technology Committee Chair to specifically assess whether acceptable performance thresholds outlined by an ASGE Preservation and Incorporation of Valuable endoscopic Innovations (PIVI) document for clinical adoption of available EBTs have been met. After conducting a comprehensive search of several English-language databases, we performed direct meta-analyses by using random-effects models to assess whether the Orbera intragastric balloon (IGB) (Apollo Endosurgery, Austin, Tex) and the EndoBarrier duodenal-jejunal bypass sleeve (DJBS) (GI Dynamics, Lexington, Mass) have met the PIVI thresholds. The meta-analyses results indicate that the Orbera IGB meets the PIVI thresholds for both primary and nonprimary bridge obesity therapy. Based on a meta-analysis of 17 studies including 1683 patients, the percentage of excess weight loss (%EWL) with the Orbera IGB at 12 months was 25.44% (95% confidence interval [CI], 21.47%-29.41%) (random model) with a mean difference in %EWL over controls of 26.9% (95% CI, 15.66%-38.24%; P ≤ .01) in 3 randomized, controlled trials. Furthermore, the pooled percentage of total body weight loss (% TBWL) after Orbera IGB implantation was 12.3% (95% CI, 7.9%­16.73%), 13.16% (95% CI, 12.37%­13.95%), and 11.27% (95% CI, 8.17%­14.36%) at 3, 6, and 12 months after implantation, respectively, thus exceeding the PIVI threshold of 5% TBWL for nonprimary (bridge) obesity therapy. With the data available, the DJBS liner does appear to meet the %EWL PIVI threshold at 12 months, resulting in 35% EWL (95% CI, 24%-46%) but does not meet the 15% EWL over control required by the PIVI. We await review of the pivotal trial data on the efficacy and safety of this device. Data are insufficient to evaluate PIVI thresholds for any other EBT at this time. Both evaluated EBTs had ≤5% incidence of serious adverse events as set by the PIVI document to indicate acceptable safety profiles. Our task force consequently recognizes the Orbera IGB for meeting the PIVI criteria for the management of obesity. As additional data from the other EBTs become available, we will update our recommendations accordingly.

Efficacy of Endoscopic Mucosal Resection for Management of Small Duodenal Neuroendocrine Tumors.

BACKGROUND: Endoscopic mucosal resection (EMR) for small (<20 mm) duodenal neuroendocrine tumors (NETs) remains controversial because of their rarity. MATERIALS AND METHODS: This is a retrospective cohort study of patients with surgically or endoscopically resected duodenal NETs from 2001 to 2011. The primary outcome is the rate of disease-free status following resection. A secondary outcome is the sensitivity of endoscopic ultrasound (EUS) in determining NET appropriateness for EMR. RESULTS: Thirty patients underwent resection of duodenal NETs (EMR 20, surgery 10). Tumor was present at the margins in 40% of EMR-resected NETs and 10% of surgically resected NETs. Five patients who underwent EMR had residual disease treated with repeat EMR (3) and surgery (2). EUS demonstrated 96% sensitivity in determining lesions limited to the submucosa. CONCLUSIONS: EMR for small duodenal NETs can be a safe and effective alternative to surgery in carefully selected patients. EUS is a useful adjunct in determining depth of invasion for duodenal NETs.

Aspiration therapy leads to weight loss in obese subjects: a pilot study.

BACKGROUND & AIMS: Obese patients rarely achieve long-term weight loss with only lifestyle interventions. We evaluated the use of endoscopic aspiration therapy for obesity. Aspiration therapy involves endoscopic placement of a gastrostomy tube (A-Tube) and the AspireAssist siphon assembly (Aspire Bariatrics, King of Prussia, PA) to aspirate gastric contents 20 minutes after meal consumption. METHODS: We performed a pilot study of 18 obese subjects who were randomly assigned (2:1) to groups that underwent aspiration therapy for 1 year plus lifestyle therapy (n = 11; mean body mass index, 42.6 ± 1.4 kg/m(2)) or lifestyle therapy only (n = 7; mean body mass index, 43.4 ± 2.0 kg/m(2)). Lifestyle intervention comprised a 15-session diet and behavioral education program. RESULTS: Ten of the 11 subjects who underwent aspiration therapy and 4 of the 7 subjects who underwent lifestyle therapy completed the first year of the study. After 1 year, subjects in the aspiration therapy group lost 18.6% ± 2.3% of their body weight (49.0% ± 7.7% of excess weight loss [EWL]) and those in the lifestyle therapy group lost 5.9% ± 5.0% (14.9% ± 12.2% of EWL) (P < .04). Seven of the 10 subjects in the aspiration therapy group completed an additional year of therapy and maintained a 20.1% ± 3.5% body weight loss (54.6% ± 12.0% of EWL). There were no adverse effects of aspiration therapy on eating behavior and no evidence of compensation for aspirated calories with increased food intake. No episodes of binge eating in the aspiration therapy group or serious adverse were reported. CONCLUSIONS: In a pilot study, aspiration therapy appears to be a safe and effective long-term weight loss therapy for obesity.

Long-term outcomes after single-balloon enteroscopy in patients with obscure gastrointestinal bleeding.

BACKGROUND: Limited data exists on the long-term outcomes of patients with obscure gastrointestinal bleeding (OGIB) following single-balloon enteroscopy (SBE). AIM: To examine the long-term outcomes of patients undergoing SBE for OGIB. METHODS: Consecutive patients undergoing SBE for OGIB at a tertiary care center between 2008 and 2010 were retrospectively identified. Clinical data and SBE findings were extracted from the medical record. Recurrence of OGIB during follow-up through 2012 was assessed by a combination of chart review and telephone interviews. RESULTS: One hundred and forty-seven patients were included in the study. The overall diagnostic yield of SBE was 64.6% (95/147 patients). Findings of SBE included vascular lesions (VLs, 53.7%), small bowel neoplasm (2.7%), inflammatory lesions (4.8%), and normal SBE (35.4%). One hundred and ten patients (56.4% female, mean age 70.6±11.3 years) were followed for an average 23.9 months after initial SBE. During follow-up, OGIB recurred in 39.5% of patients in whom a source of OGIB was identified on SBE and 55.9% of patients with normal findings on SBE. OGIB recurred in 47.6% of patients in whom small bowel VLs were treated endoscopically. None of the 13 patients in whom a non-VL lesion was identified as the source of bleeding on SBE experienced recurrent bleeding (p=0.019). CONCLUSIONS: SBE is a safe and valuable method for managing patients with OGIB. More than 50% of patients experienced no recurrent bleeding during 2 years of follow-up after SBE. The long-term management of OGIB due to small bowel VLs remains challenging.

Sensitivity of endoscopic ultrasound, multidetector computed tomography, and magnetic resonance cholangiopancreatography in the diagnosis of pancreas divisum: a tertiary center experience.

OBJECTIVES: There are limited data comparing imaging modalities in the diagnosis of pancreas divisum. We aimed to: (1) evaluate the sensitivity of endoscopic ultrasound (EUS), magnetic resonance cholangiopancreatography (MRCP), and multidetector computed tomography (MDCT) for pancreas divisum; and (2) assess interobserver agreement (IOA) among expert radiologists for detecting pancreas divisum on MDCT and MRCP. METHODS: For this retrospective cohort study, we identified 45 consecutive patients with pancreaticobiliary symptoms and pancreas divisum established by endoscopic retrograde pancreatography who underwent EUS and cross-sectional imaging. The control group was composed of patients without pancreas divisum who underwent endoscopic retrograde pancreatography and cross-sectional imaging. RESULTS: The sensitivity of EUS for pancreas divisum was 86.7%, significantly higher than the sensitivity reported in the medical records for MDCT (15.5%) or MRCP (60%) (P < 0.001 for each). On review by expert radiologists, the sensitivity of MDCT increased to 83.3% in cases where the pancreatic duct was visualized, with fair IOA (κ = 0.34). Expert review of MRCPs did not identify any additional cases of pancreas divisum; IOA was moderate (κ = 0.43). CONCLUSIONS: Endoscopic ultrasound is a sensitive test for diagnosing pancreas divisum and is superior to MDCT and MRCP. Review of MDCT studies by expert radiologists substantially raises its sensitivity for pancreas divisum.

Use of a pancreatic duct stent or guidewire facilitates bile duct access with low rates of precut sphincterotomy: a randomized clinical trial.

BACKGROUND AND STUDY AIMS: Among cases of difficult biliary cannulation, alternatives include use of a pancreatic duct stent (PDS) or guidewire (PDW) to facilitate access. We compared the effectiveness of a PDS versus a PDW to facilitate common bile duct (CBD) cannulation. PATIENTS AND METHODS: We conducted a randomized, crossover trial at two endoscopy referral centers, limited to patients undergoing ERCP without a history of biliary sphincterotomy. After meeting predefined criteria for difficult cannulation, patients were randomized to using a PDS or PDW to facilitate CBD cannulation. Outcomes included cannulation rate within 6 min, overall cannulation rate, frequency of precut, and complication rates. RESULTS: Among 442 eligible patients, 87 (19.7 %) met criteria for difficult cannulation. Forty two were randomized to PDW, 54 to PDS (including 9 PDW patients crossed over to PDS). The rate of CBD cannulation within 6 min was similar in the PDW (38.1 %) and PDS (51.9 %) groups (p = 0.18). In a secondary analysis limited to patients who successfully underwent PDW or PDS deployment, the rate was also comparable (PDW 59.3 %, PDS 65.1 %; p = 0.62). The overall frequency of CBD cannulation was 66.7 % in PDW and 90.7 % in PDS patients. Precut was required in 9.5 % of PDW and 25.9 % of PDS patients. Complication rates were similar, with 4 (4.6 %) patients having post-ERCP pancreatitis and 1 (1.1 %) having post-ERCP pain without confirmation of pancreatitis. CONCLUSIONS: Use of a PDS or PDW facilitates CBD cannulation while maintaining a low complication rate and reducing the need for precut sphincterotomy in the majority of cases.

Prevalence of advanced histological features in diminutive and small colon polyps.

BACKGROUND: Investigators have proposed "predict, resect, and discard" strategies for diminutive (≤ 5 mm) or small (6-9 mm) polyps to reduce screening colonoscopy costs. Advanced histological features such as villous histology, high-grade dysplasia, and/or cancer in these polyps could deter adoption of these strategies. OBJECTIVE: Determine the prevalence of advanced histological features in diminutive and small colon polyps. DESIGN: Retrospective analysis of data from 3 prospective clinical trials. SETTING: Two tertiary-care referral centers. PATIENTS: This study involved patients undergoing screening or surveillance colonoscopy. INTERVENTION: The location, size, and morphology of each polyp detected was documented. Each polyp was then resected, placed in a unique specimen jar, and sent for histopathological evaluation. MAIN OUTCOME MEASUREMENTS: Rates of advanced histological features (villous histology, high-grade dysplasia, and cancer). RESULTS: A total of 2361 polyps were detected, removed, and retrieved. Both diminutive and small polyps had a lower frequency of any advanced histological features compared with large polyps (0.5% and 1.5%, respectively vs 15.0%; P < .001 for both comparisons). Polyps <10 mm in size had a lower frequency of advanced histology compared with polyps ≥ 10 mm (0.8% vs 15.0%; P < .001). During sensitivity analysis, the frequency of advanced histological features varied from 0.2% to 0.7% within diminutive polyps, 1.5% to 3.6% within small polyps, and 0.8% to 1.2% within polyps <10 mm. LIMITATIONS: Retrospective analysis from tertiary-care referral centers; predominantly white, male, veteran patient population resulting in limited generalizability of results. CONCLUSION: The prevalence of advanced histological features in colon polyps ≤ 5 mm is very low (0.5%). This has important implications for the potential practice of "predicting, resecting, and discarding" diminutive colon polyps.

Accuracy of in vivo optical diagnosis of colon polyp histology by narrow-band imaging in predicting colonoscopy surveillance intervals.

BACKGROUND: The American Society for Gastrointestinal Endoscopy (ASGE) recently developed thresholds for the performance characteristics of technologies for real-time assessment of histology of diminutive (≤ 5 mm) colon polyps. Narrow-band imaging (NBI) has been shown to predict polyp histology with moderate to high accuracy in several studies. OBJECTIVE: To determine whether in vivo optical diagnosis of polyp histology by using NBI can reach the 2 benchmarks set forth by the ASGE. DESIGN: Retrospective analysis of data from 3 prospective clinical trials. SETTING: Two tertiary referral centers. PATIENTS: Subjects undergoing screening or surveillance colonoscopy. INTERVENTIONS: In vivo optical diagnosis of polyp histology by using NBI. MAIN OUTCOME MEASUREMENT: Accuracy in predicting colonoscopy surveillance intervals, negative predictive value (NPV) for diagnosing adenomatous histology in the rectosigmoid. RESULTS: A total of 410 patients met the inclusion/exclusion criteria and had at least 1 polyp seen and resected during colonoscopy. Using in vivo optical diagnosis instead of histopathology for all diminutive polyps predicted the correct colonoscopy surveillance interval in 86% to 94% patients. When optical diagnosis was limited to diminutive polyps in the rectosigmoid only, the NPV for diagnosing adenomatous histology with NBI was 95%. LIMITATIONS: Retrospective analysis from tertiary referral centers. CONCLUSIONS: The threshold NPV for diagnosing adenomatous histology in diminutive rectosigmoid polyps recently set forth by the ASGE can be achieved by using NBI. The threshold accuracy rate for predicting surveillance interval recommendations can be reached by using NBI, but only if patients with 1 to 2 small adenomas without advanced features have a repeat colonoscopy in 10 years.

Obesity as a risk factor for sedation-related complications during propofol-mediated sedation for advanced endoscopic procedures.

BACKGROUND: There are limited data on the safety of anesthesia-assisted endoscopy by using propofol-mediated sedation in obese individuals undergoing advanced endoscopic procedures (AEPs). OBJECTIVE: To study the association between obesity (as measured by body mass index [BMI]) and the frequency of sedation-related complications (SRCs) in patients undergoing AEPs. DESIGN: Prospective cohort study. SETTING: Tertiary referral center. PATIENTS: A total of 1016 consecutive patients undergoing AEPs (BMI <30, 730 [72%]; 30-35, 159 [16%]; >35, 127 [12%]). INTERVENTION: Monitored anesthesia sedation with propofol alone or in combination with benzodiazepines and/or opioids. MAIN OUTCOME MEASUREMENTS: SRCs, airway maneuvers (AMs), hypoxemia, hypotension requiring vasopressors, and early procedure termination were compared across 3 groups. RESULTS: There were 203 AMs in 13.9% of patients, hypoxemia in 7.3%, need for vasopressors in 0.8%, and premature termination in 0.6% of patients. Increasing BMI was associated with an increased frequency of AMs (BMI <30, 10.5%; 30-35, 18.9%; >35-26.8%; P < .001) and hypoxemia (BMI <30, 5.3%; 30-35, 9.4%; >35, 13.4%; P = .001); there was no difference in the frequency of need for vasopressors (P = .254) and premature termination of procedures (P = .401). On multivariable analysis, BMI (odds ratio [OR] 2.0; 95% CI, 1.3-3.1), age (OR 1.1; 95% CI, 1.0-1.1), and American Society of Anesthesiologists class 3 or higher (OR 2.4; 95% CI, 1.1-5.0) were independent predictors of SRCs. In obese individuals (n = 286), there was no difference in the frequency of SRCs in patients receiving propofol alone or in combination (P = .48). LIMITATIONS: Single tertiary center study. CONCLUSIONS: Although obesity was associated with an increased frequency of SRCs, propofol sedation can be used safely in obese patients undergoing AEPs when administered by trained professionals.

Randomized, controlled trial of standard-definition white-light, high-definition white-light, and narrow-band imaging colonoscopy for the detection of colon polyps and prediction of polyp histology.

BACKGROUND: Missing adenomas and the inability to accurately differentiate between polyp histology remain the main limitations of standard-definition white-light (SD-WL) colonoscopy. OBJECTIVE: To compare the adenoma detection rates of SD-WL with those of high-definition white-light (HD-WL) and narrow-band imaging (NBI) as well as the accuracy of predicting polyp histology. DESIGN: Multicenter, prospective, randomized, controlled trial. SETTING: Two academic medical centers in the United States. PATIENTS: Subjects undergoing screening or surveillance colonoscopy. INTERVENTION: Subjects were randomized to undergo colonoscopy with one of the following: SD-WL, HD-WL, or NBI. MAIN OUTCOME MEASUREMENTS: The proportion of subjects detected with adenomas, adenomas detected per subject, and the accuracy of predicting polyp histology real time. RESULTS: A total of 630 subjects were included. The proportion of subjects with adenomas was 38.6% with SD-WL compared with 45.7% with HD-WL and 46.2% with NBI (P = .17 and P = .14, respectively). Adenomas detected per subject were 0.69 with SD-WL compared with 1.12 with HD-WL and 1.13 with NBI (P = .016 and P = .014, respectively). HD-WL and NBI detected more subjects with flat and right-sided adenomas compared with SD-WL (all P values <.005). NBI had a superior sensitivity (90%) and accuracy (82%) to predict adenomas compared with SD-WL and HD-WL (all P values <.005). LIMITATIONS: Academic medical centers with experienced endoscopists. CONCLUSIONS: There was no difference in the proportion of subjects with adenomas detected with SD-WL, HD-WL, and NBI. However, HD-WL and NBI detected significantly more adenomas per subject (>60%) compared with SD-WL. NBI had the highest accuracy in predicting adenomas in real time during colonoscopy. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT 00614770.).

Timing of endoscopy after extracorporeal shock wave lithotripsy for chronic pancreatitis.

OBJECTIVES: Extracorporeal shock wave lithotripsy (ESWL) and endoscopic retrograde cholangiopancreatography (ERCP) are used to clear main pancreatic duct (MPD) stones and alleviate pain in patients with chronic pancreatitis. The goal of this study was to determine if delayed ERCP after disintegration of MPD stones with ESWL improves the successful clearance of the MPD. METHODS: Adult patients with chronic pancreatitis who underwent ESWL for stone disintegration were identified from an ESWL database at a single tertiary referral center. The complete clearance of stones from the MPD with ERCP performed less than 2 days after ESWL was compared to complete clearance from ERCP more than 2 days after ESWL. RESULTS: Nineteen patients underwent ERCP less than 2 days after ESWL, and 3 (16%) of the 19 achieved MPD clearance. Eleven patients underwent ERCP more than 2 days after ESWL, and 9 (82%) of 11 patients achieved MPD clearance (P = 0.001). In total, 19 of 30 ERCPs were performed less than 2 days after ESWL, and 84% failed to clear the MPD (P = 0.001). CONCLUSIONS: The timing of ERCP after ESWL may be important to successfully clear stones from the MPD. This study shows that ERCP performed less than 2 days after ESWL may be more likely to fail, possibly owing to ESWL-induced edema. Delaying ERCP after ESWL may allow tissue recovery after ESWL.