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.

Snare Tip Soft Coagulation vs Argon Plasma Coagulation vs No Margin Treatment After Large Nonpedunculated Colorectal Polyp Resection: a Randomized Trial.

BACKGROUND & AIMS: Thermal treatment of the defect margin after endoscopic mucosal resection (EMR) of large nonpedunculated colorectal lesions reduces the recurrence rate. Both snare tip soft coagulation (STSC) and argon plasma coagulation (APC) have been used for thermal margin treatment, but there are few data directly comparing STSC with APC for this indication. METHODS: We performed a randomized 3-arm trial in 9 US centers comparing STSC with APC with no margin treatment (control) of defects after EMR of colorectal nonpedunculated lesions ≥15 mm. The primary end point was the presence of residual lesion at first follow-up. RESULTS: There were 384 patients and 414 lesions randomized, and 308 patients (80.2%) with 328 lesions completed ≥1 follow-up. The proportion of lesions with residual polyp at first follow-up was 4.6% with STSC, 9.3% with APC, and 21.4% with control subjects (no margin treatment). The odds of residual polyp at first follow-up were lower for STSC and APC when compared with control subjects (P = .001 and P = .01, respectively). The difference in odds was not significant between STSC and APC. STSC took less time to apply than APC (median, 3.35 vs 4.08 minutes; P = .019). Adverse event rates were low, with no difference between arms. CONCLUSIONS: In a randomized trial STSC and APC were each superior to no thermal margin treatment after EMR. STSC was faster to apply than APC. Because STSC also results in lower cost and plastic waste than APC (APC requires an additional device), our study supports STSC as the preferred thermal margin treatment after colorectal EMR. (Clinicaltrials.gov, Number NCT03654209.).

Celiac Plexus Neurolysis Is Associated With Decreased Survival in Patients With Pancreatic Cancer: A Propensity Score Analysis.

OBJECTIVE: The aim of this study was to investigate survival in patients who received celiac plexus neurolysis (CPN) compared with patients who received opioids. METHODS: The Surveillance, Epidemiology and End Results-Medicare database was used to identify patients older than 65 years diagnosed with pancreatic cancer between 2007 and 2015. We used claims data to identify patients with a history of CPN and opioid use within 1 year of diagnosis, and other demographic, clinical, and treatment variables. Kaplan-Meier analyses and inverse propensity-weighted adjusted Cox proportional hazard ratios were used to evaluate survival. RESULTS: We identified 648 patients who underwent CPN (19.0%) compared with 2769 patients who received opioids (81.0%). The median survival and interquartile range for patients who received CPN was 4.0 months (2.0-8.0 months) compared with 7.0 months (3.0-12.0 months) for opioid users (P < 0.0001). After adjusting for confounders and propensity score, the patients who received CPN showed worsened survival (hazard ratio, 1.69; 95% confidence interval, 1.59-1.79). CONCLUSIONS: Pancreatic cancer patients who underwent CPN had decreased survival compared with opioid users. This suggests that opioid sparing methods to reduce pancreatic cancer pain may actually be harmful. Future prospective studies should investigate whether other opioid sparing therapies impact pancreatic cancer survival.

Use of endoscopic ultrasound for pancreatic cancer from 2000 to 2016.

Background and study aims Pancreatic cancer (PC) is the fourth most common cause of cancer death in the United States. Previous studies have suggested a survival benefit for endoscopic ultrasound (EUS), an important tool for diagnosis and staging of PC. This study aims to describe EUS use over time and identify factors associated with EUS use and its impact on survival. Patients and methods This was a retrospective review of the Surveillance, Epidemiology and End Results (SEER) database linked with Medicare claims. EUS use, clinical and demographic characteristics were evaluated. Chi-squared analysis, Cochran-Armitage test for trend, and logistic regression were used to identify associations between sociodemographic and clinical factors and EUS. Kaplan-Meier and Cox proportional hazard ratios were used for survival analysis. Results EUS use rose during the time period, from 7.4 % of patients in 2000 to 32.4 % in 2015. Patient diversity increased, with a rising share of older, non-White patients with higher Charlson comorbidity scores. Both clinical (receipt of other therapies, PC stage) and nonclinical factors (region of country, year of diagnosis) were associated with receipt of EUS. While EUS was associated with a survival improvement early in the study period, this effect did not persist for PC patients diagnosed in 2012 to 2015 (median survival 3 month ± standard deviation [SD] 9.8 months without vs. 4 months ± SD 8 months with EUS). Conclusions Our data support previous studies, which suggest a survival benefit for EUS when it was infrequently used, but finds that benefit was attenuated as EUS became more widely available.

American Society for Gastrointestinal Endoscopy guideline on informed consent for GI endoscopic procedures.

Informed consent is the cornerstone of the ethical practice of procedures and treatments in medicine. The purpose of this document from the American Society for Gastrointestinal Endoscopy (ASGE) Standards of Practice Committee is to provide an update on best practice of the informed consent process and other issues around informed consent and shared decision-making for endoscopic procedures. The principles of informed consent are based on longstanding legal doctrine. Several new concepts and clinical trials addressing the best practice of informed consent will help guide practitioners of the burgeoning field of GI endoscopic procedures. After a literature review and an iterative discussion and voting process by the ASGE Standards of Practice Committee, this document was produced to update our guidance on informed consent for the practicing endoscopist. Because this document was designed by considering the laws and broad practice of endoscopy in the United States, legal requirements may differ by state and region, and it is the responsibility of the endoscopist, practice managers, and other healthcare organizations to be aware of local laws. Our recommendations are designed to improve the informed consent experience for both physicians and patients as they work together to diagnose and treat GI diseases with endoscopy.

Endoscopic ultrasound-guided biliary drainage in benign biliary pathology with normal foregut anatomy: a multicenter study.

BACKGROUND AND AIMS: Biliary drainage using endoscopic ultrasound (EUS-BD) has been developed as a novel technique to obtain biliary access and drainage when ERCP fails. Numerous studies have demonstrated its safety and efficacy specifically pertaining to those with malignant distal biliary obstruction or altered foregut anatomy. The aim of this study is to evaluate the safety and efficacy of EUS-BD in benign indications in patients with normal foregut anatomy. METHODS: We performed a retrospective comparative study from 5 academic medical centers (2008-2018) involving patients with benign biliary obstruction and native foregut anatomy who had an initial failed ERCP with subsequent attempt at biliary decompression via EUS-BD or by repeating ERCP. RESULTS: 36 patients (mean age 61.6 ± 2.2, 38.9% female) who underwent attempted EUS-BD following initial failed ERCP were compared to 50 patients (mean age 62.7 ± 2.3, 73.5% female) who underwent repeat ERCP following an initial failed cannulation. EUS-BD was technically successful in 28 (77.8%) patients with rendezvous being the most common approach (86.1%). A higher level of pre-procedural bilirubin was found to be associated with technical success of EUS-BD (3.65 ± 0.63 versus 1.1 ± 0.4, p value 0.04). Success of repeat ERCP following failed cannulation was 86%. Adverse events were significantly more frequent in the EUS-BD cohort when compared to the repeat ERCP (10 (27.8%) versus 4 (8.0%), p = 0.02, OR 4.32. CONCLUSIONS: EUS-BD remains a viable therapeutic option in the setting of benign biliary disease, with success rates of 77.8%. Adverse events were significantly more common with EUS-BD vs. repeat ERCP, emphasizing the need to perform in expert centers with appropriate multidisciplinary support and to strongly consider the urgency of biliary decompression before considering same session EUS-BD after failed initial biliary access.

Endoscopic resection outcomes and predictors of failed en bloc endoscopic mucosal resection of colorectal polyps ≤ 20 mm among advanced endoscopy trainees.

Background and study aims En bloc endoscopic mucosal resection (EMR) is preferred over piecemeal resection for polyps ≤ 20 mm. Data on colorectal EMR training are limited. We aimed to evaluate the en bloc EMR rate of polyps ≤ 20 mm among advanced endoscopy trainees and to identify predictors of failed en bloc EMR. Methods This was a multicenter prospective study evaluating trainee performance in EMR during advanced endoscopy fellowship. A logistic regression model was used to identify the number of procedures and lesion cut-off size associated with an en bloc EMR rate of ≥ 80 %. Multivariate analysis was performed to identify predictors of failed en bloc EMR. Results Six trainees from six centers performed 189 colorectal EMRs, of which 104 (55 %) were for polyps ≤ 20 mm. Of these, 57.7 % (60/104) were resected en bloc. Trainees with ≥ 30 EMRs (OR 6.80; 95 % CI: 2.80-16.50; P  = 0.00001) and lesions ≤ 17 mm (OR 4.56;95 CI:1.23-16.88; P  = 0.02) were more likely to be associated with an en bloc EMR rate of ≥ 80 %. Independent predictors of failed en bloc EMR on multivariate analysis included: larger polyp size (OR:6.83;95 % CI:2.55-18.4; P  = 0.0001), right colon location (OR:7.15; 95 % CI:1.31-38.9; P  = 0.02), increased procedural difficulty (OR 2.99; 95 % CI:1.13-7.91; P  = 0.03), and having performed < 30 EMRs (OR: 4.87; 95 %CI: 1.05-22.61; P  = 0.04). Conclusions In this pilot study, we demonstrated that a relatively low proportion of trainees achieved en bloc EMR for polyps ≤ 20 mm and identified procedure volume and lesion size thresholds for successful en bloc EMR and independent predictors for failed en bloc resection. These preliminary results support the need for future efforts to define EMR procedure competence thresholds during training.

Direct Endoscopic Necrosectomy With and Without Hydrogen Peroxide for Walled-off Pancreatic Necrosis: A Multicenter Comparative Study.

INTRODUCTION: Endoscopic necrosectomy has emerged as the preferred treatment modality for walled-off pancreatic necrosis. This study was designed to evaluate the safety and efficacy of direct endoscopic necrosectomy with and without hydrogen peroxide (H2O2) lavage. METHODS: Retrospective chart reviews were performed for all patients undergoing endoscopic transmural management of walled-off pancreatic necrosis at 9 major medical centers from November 2011 to August 2018. Clinical success was defined as the resolution of the collection by imaging within 6 months, without requiring non-endoscopic procedures or surgery. RESULTS: Of 293 patients, 204 met the inclusion criteria. Technical and clinical success rates were 100% (204/204) and 81% (166/189), respectively. For patients, 122 (59.8%) patients had at least one H2O2 necrosectomy (H2O2 group) and 82 (40.2%) patients had standard endoscopic necrosectomy. Clinical success was higher in the H2O2 group: 106/113 (93.8%) vs 60/76 (78.9%), P = 0.002. On a multivariate analysis, the use of H2O2 was associated with higher clinical success rate (odds ratio 3.30, P = 0.033) and earlier resolution (odds ratio 2.27, P < 0.001). During a mean follow-up of 274 days, 27 complications occurred. Comparing procedures performed with and without H2O2 (n = 250 vs 183), there was no difference in post-procedure bleeding (7 vs 9, P = 0.25), perforation (2 vs 3, P = 0.66), infection (1 vs 2, P = 0.58), or overall complication rate (n = 13 [5.2%] vs 14 [7.7%], P = 0.30). DISCUSSION: H2O2-assisted endoscopic necrosectomy had a higher clinical success rate and a shorter time to resolution with equivalent complication rates relative to standard necrosectomy.See the visual abstract at http://links.lww.com/AJG/B714.(Equation is included in full-text article.).

Characteristics and Outcomes of Patients Undergoing Endoscopy During the COVID-19 Pandemic: A Multicenter Study from New York City.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has significantly impacted the practice of endoscopy, but characteristics of COVID patients undergoing endoscopy have not been adequately described. AIMS: To compare findings, clinical outcomes, and patient characteristics of endoscopies performed during the pandemic in patients with and without COVID-19. METHODS: This was a retrospective multicenter study of adult endoscopies at six academic hospitals in New York between March 16 and April 30, 2020. Patient and procedure characteristics including age, sex, indication, findings, interventions, and outcomes were compared in patients testing positive, negative, or untested for COVID-19. RESULTS: Six hundred and five endoscopies were performed on 545 patients during the study period. There were 84 (13.9%), 255 (42.2%), and 266 (44.0%) procedures on COVID-positive, negative, and untested patients, respectively. COVID patients were more likely to undergo endoscopy for gastrointestinal bleeding or gastrostomy tube placement, and COVID patients with gastrointestinal bleeding more often required hemostatic interventions on multivariable logistic regression. COVID patients had increased length of stay, intensive care unit admission, and intubation rate. Twenty-seven of 521 patients (5.2%) with no or negative COVID testing prior to endoscopy later tested positive, a median of 13.5 days post-procedure. CONCLUSIONS: Endoscopies in COVID patients were more likely to require interventions, due either to more severe illness or a higher threshold to perform endoscopy. A significant number of patients endoscoped without testing were subsequently found to be COVID-positive. Gastroenterologists in areas affected by the pandemic must adapt to changing patterns of endoscopy practice and ensure pre-endoscopy COVID testing.

Prospective evaluation of an assessment tool for technical performance of duodenoscopes.

OBJECTIVE: While single-use and detachable-tip duodenoscopes have been recently developed to overcome risks of infection transmission, there are no reliable tools to objectively assess their technical performance. We evaluated the reliability and validity of a newly developed tool to assess the technical performance of reusable duodenoscopes. METHODS: An assessment tool was developed to measure duodenoscope performance based on three distinct criteria: maneuverability, mechanical/imaging characteristics and ability to perform requisite interventions. The assessment tool was tested prospectively on duodenoscopes used in endoscopic retrograde cholangiopancreatography (ERCP) procedures at nine academic medical centers over a 6-month period. The main outcome was reliability of the duodenoscope assessment tool, which was estimated using Cronbach's coefficient alpha (α). The secondary outcome was validity of the assessment tool. RESULTS: The assessment tool evaluated technical performance of reusable duodenoscopes in 1080 ERCP procedures. Indications were biliary in 92.8% and pancreatic in 7.2% procedures. The overall Cronbach's coefficient α for maneuverability was 0.81, assessment of mechanical/imaging characteristics was 0.92, and ability to perform requisite interventions was 0.87. On multiple linear regression analysis, prolonged procedure duration, older patient age and pancreatic interventions were significantly positively associated with higher (worse) scores. CONCLUSIONS: The newly developed assessment tool appears reliable and valid for evaluating the technical performance of duodenoscopes. Registration: ClinicalTrials.gov Identifier: NCT04004533.

Evaluating learning curves and competence in colorectal EMR among advanced endoscopy fellows: a pilot multicenter prospective trial using cumulative sum analysis.

BACKGROUND AND AIMS: Data on colorectal EMR (C-EMR) training are lacking. We aimed to evaluate C-EMR training among advanced endoscopy fellows (AEFs) by using a standardized assessment tool (STAT). METHODS: This multicenter prospective study used a STAT to grade AEF training in C-EMR during their 12-month fellowship. Cumulative sum analysis was used to establish learning curves and competence for cognitive and technical components of C-EMR and overall performance. Sensitivity analysis was performed by varying failure rates. AEFs completed a self-assessment questionnaire to assess their comfort level with performing C-EMR at the completion of their fellowship. RESULTS: Six AEFs (189 C-EMRs; mean per AEF, 31.5 ± 18.5) were included. Mean polyp size was 24.3 ± 12.6 mm, and mean procedure time was 22.6 ± 16.1 minutes. Learning curve analyses revealed that less than 50% of AEFs achieved competence for key cognitive and technical C-EMR endpoints. All 6 AEFs reported feeling comfortable performing C-EMR independently at the end of their training, although only 2 of them achieved competence in their overall performance. The minimum threshold to achieve competence in these 2 AEFs was 25 C-EMRs. CONCLUSIONS: A relatively low proportion of AEFs achieved competence on key cognitive and technical aspects of C-EMR during their 12-month fellowship. The relatively low number of C-EMRs performed by AEFs may be insufficient to achieve competence, in spite of their self-reported readiness for independent practice. These pilot data serve as an initial framework for competence threshold, and suggest the need for validated tools for formal C-EMR training assessment.

Pancreatic Fungal Infection in Patients With Necrotizing Pancreatitis: A Systematic Review and Meta-analysis.

GOAL: The goal of this study was to study the incidence of fungal infection in necrotizing pancreatitis (NP) and its impact on mortality. BACKGROUND: Infected pancreatic necrosis is a major contributor to morbidity and mortality in patients with NP. While pancreatic fungal infection (PFI) has frequently been identified in patients with NP, its effect on the clinical outcomes is unclear. MATERIALS AND METHODS: A literature search was performed in Medline (Ovid), Embase (Ovid), and the Cochrane library. All prospective and retrospective studies that examined the incidence of fungal infection in NP with subgroup mortality data were included. For fungal infection of NP, studies with fungal isolation from pancreatic necrotic tissue were included. Newcastle Ottawa Scale and Joanna Briggs Institute's critical appraisal tool were used for bias assessment. RESULTS: Twenty-two studies comprising 2151 subjects with NP were included for the quantitative analysis. The mean incidence of fungal infection was 26.6% (572/2151). In-hospital mortality in the pooled sample of NP patients with PFI (N=572) was significantly higher [odds ratio (OR)=3.95, 95% confidence interval (CI): 2.6-5.8] than those without PFI. In a separate analysis of 7 studies, the mean difference in the length of stay between those with and without fungal infection was 22.99 days (95% CI: 14.67-31.3). The rate of intensive care unit admission (OR=3.95; 95% CI: 2.6-5.8), use of prophylactic antibacterials (OR=2.76; 95% CI: 1.31-5.81) and duration of antibacterial therapy (mean difference=8.71 d; 95% CI: 1.33-16.09) were all significantly higher in patients with PFI. Moderate heterogeneity was identified among the studies on estimating OR for mortality (I2=43%) between the 2 groups. CONCLUSIONS: PFI is common in patients with NP and is associated with increased mortality, intensive care unit admission rate, and length of stay. Further prospective studies are needed to better understand the pathophysiology of PFIs and to determine the role for preemptive therapeutic strategies, such as prophylactic antifungal therapy.

ASGE guideline on the role of endoscopy in the management of benign and malignant gastroduodenal obstruction.

This American Society for Gastrointestinal Endoscopy guideline provides evidence-based recommendations for the endoscopic management of gastric outlet obstruction (GOO). We applied the Grading of Recommendations, Assessment, Development and Evaluation methodology to address key clinical questions. These include the comparison of (1) surgical gastrojejunostomy to the placement of self-expandable metallic stents (SEMS) for malignant GOO, (2) covered versus uncovered SEMS for malignant GOO, and (3) endoscopic and surgical interventions for the management of benign GOO. Recommendations provided in this document were founded on the certainty of the evidence, balance of benefits and harms, considerations of patient and caregiver preferences, resource utilization, and cost-effectiveness.

Primary EUS-guided biliary drainage versus ERCP drainage for the management of malignant biliary obstruction: A systematic review and meta-analysis.

EUS-guided biliary drainage (EUS-BD) has been used as a salvage modality for relief of malignant biliary obstruction (MBO) after a failed ERCP. Multiple recent randomized controlled trials (RCTs) and observational studies have been published to assess the suitability of EUS-BD as a first-line modality for achieving palliative BD. We aimed to perform a systematic review and meta-analysis comparing primary EUS-BD versus ERCP for MBO. We searched PubMed, Medline, and Embase up to January 1, 2019, to identify RCTs and observational studies evaluating the efficacy and safety of primary EUS-BD (without a prior attempted ERCP) versus ERCP. Quality of RCTs and observational studies was assessed using Jadad and Newcastle-Ottawa scores, respectively. The outcomes of interest were technical success, clinical success, odds of requiring a repeat intervention, and procedure-related adverse events. Odds ratios (ORs) and standard mean difference were calculated for categorical and continuous variables, respectively. Meta-analysis was performed using the random effects model in RevMan 5.3 (the Cochrane Collaboration, the Nordic Cochrane Centre, Copenhagen, Denmark). Five studies (three RCTs and two observational studies) with 361 patients were included. Both procedures achieved comparable technical success (OR: 1.20 [0.44-3.24], I2 = 0%) and clinical success (OR: 1.44, confidence interval [CI]: 0.63-3.29, I2 = 0%). The overall adverse outcomes (OR: 1.59 [0.89-2.84]) did not differ between the two groups. In the ERCP group, 9.5% of patients developed procedure-related pancreatitis versus zero in the EUS group (risk difference = 0.08%, P = 0.02). There was no statistically significant difference in nonpancreatitis-related adverse events. The odds of requiring reintervention for BD (1.68 [0.76-3.73], I2 = 42%) did not differ significantly. The ERCP group had significantly higher odds of requiring reintervention due to tumor overgrowth (5.35 [1.64-17.50], I2 = 0%). EUS-BD has comparable technical and clinical success to ERCP and can potentially be used as a first-line palliative modality for MBO where expertise is available. ERCP-related pancreatitis which can cause significant morbidity can be completely avoided with EUS.