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Presents a study which described the use of combined endoscopic-laparpscopic approach for clearance of the common bile duct and removal of the gall bladder in symptomatic patients with simultaneous cholcystolithiasis and choledocholithiasis. Patients and methods; Length of hospital stay and convalescence by management technique for common bile duct stones; Results; Discussion.

Limited data exist regarding patient-reported outcomes and quality of life (QOL) experienced by patients with Barrett's esophagus (BE) referred for endoscopic eradication therapy (EET). Specifically, the impact of grade of dysplasia has not been explored. The purpose of this study is to measure patient-reported symptoms and QOL and identify factors associated with poor QOL in BE patients referred for EET. This was a prospective multicenter study conducted from January 2015 to October 2017, which included patients with BE referred for EET. Participants completed a set of validated questionnaires to measure QOL, symptom severity, and psychosocial factors. The primary outcome was poor QOL defined by a PROMIS score >12. Multivariable logistic regression analysis was performed to identify factors associated with poor QOL. In total, 193 patients participated (mean age 64.6 years, BE length 5.5 cm, 82% males, 92% Caucasians) with poor QOL reported in 104 (53.9%) participants. On univariate analysis, patients with poor QOL had lower use of twice daily proton pump inhibitor use (61.5% vs. 86.5%, P  = 0.03), shorter disease duration (4.9 vs. 5.9 years, P  = 0.04) and progressive increase in grade of dysplasia (high-grade dysplasia: 68.8% vs. 31.3%, esophageal adenocarcinoma: 75.5% vs. 24.5%, P  < 0.001). Multivariate analysis demonstrated that high-grade dysplasia was independently associated with poor QOL (OR: 5.57, 95% CI: 1.05, 29.5, P  = 0.04). In summary, poor QOL is experienced by the majority of patients with BE referred for EET and the degree of dysplasia was independently associated with poor QOL, which emphasizes the need to incorporate patient-centered outcomes when studying treatment of BE-related dysplasia. [ABSTRACT FROM AUTHOR]

Objective: We evaluated a protocolized endoscopic necrosectomy approach with a lumen-apposing metal stent (LAMS) in patients with large symptomatic walled-off pancreatic necrosis (WON) comprising significant necrotic content, with or without infection., Summary Background Data: Randomized trials have shown similar efficacy of endoscopic treatment compared with surgery for infected WON., Design: We conducted a regulatory, prospective, multicenter single-arm clinical trial examining the efficacy and safety of endoscopic ultrasound -guided LAMS with protocolized necrosectomy to treat symptomatic WON ≥6 cm in diameter with >30% solid necrosis. After LAMS placement, protocolized WON assessment was conducted and endoscopic necrosectomy was performed for insufficient WON size reduction and persistent symptoms. Patients with radiographic WON resolution to ≤ 3 cm and/or 60-day LAMS indwell had LAMS removal, then 6-month follow-up. Primary endpoints were probability of radiographic resolution by 60 days and procedure-related serious adverse events., Results: Forty consecutive patients were enrolled September 2018 to March 2020, of whom 27 (67.5%) were inpatients and 19 (47.5%) had clinical evidence of infection at their index procedure. Mean WON size was 15.0 ± 5.6 cm with mean 53.2% ± 16.7% solid necrosis. Radiographic WON resolution was seen in 97.5% (95% CI, 86.8%, 99.9%) by 60 days, without recurrence in 34 patients with 6-month follow-up data. Mean time to radiographic WON resolution was 34.1 ± 16.8 days. Serious adverse events occurred in 3 patients (7.5%), including sepsis, vancomycin-resistant enterococcal bacteremia and shock, and upper gastrointestinal bleeding. There were no procedure-related deaths., Conclusions: Endoscopic ultrasound-guided drainage with protocolized endoscopic necrosectomy to treat large symptomatic or infected walled-off necrotic pancreatic collections was highly effective and safe. Clinicaltrials.-gov no: NCT03525808., Competing Interests: All other authors report no conflicts of interest., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.)

Background and Aims: Fully covered self-expandable metal stents (FCSEMSs) may offer a treatment option for pain associated with a dilated pancreatic duct (PD) in chronic pancreatitis (CP), but optimal patient selection and FCSEMS design, efficacy, and safety remain uncertain. We studied an investigational pancreatic FCSEMS for treatment of CP-associated pain., Methods: Patients with painful CP, a dominant distal PD stricture, and PD dilation upstream were enrolled in a prospective, multicenter, single-arm trial studying 6-month indwell of a 4- to 6-cm-long soft pancreatic FCSEMS. Primary efficacy and safety endpoints were pain reduction 6 months after FCSEMS indwell (performance goal ≥53%) and PD stenting-related serious adverse events (SAEs), respectively (performance goal <32%). The primary efficacy endpoint was assessed in patients with sufficiently severe and frequent pain at FCSEMS placement as a first stent or in exchange of a plastic stent., Results: Among 67 patients (mean age, 52.7 ± 12.5 years; mean time since CP diagnosis, 6.4 ± 6.4 years), 34 (50.7%) had plastic stent placement within 90 days of FCSEMS placement, and 46 patients were eligible for the primary efficacy endpoint analysis. Technical success was 97.0% (65/67). The observed primary efficacy (26.1%, 12/46) and safety endpoints (31.3%, 21/67) failed to meet the a priori study hypotheses. Study stent migration occurred in 47.7% of patients (31/65)., Conclusions: Six-month treatment with an FCSEMS did not lead to an expected degree of pain reduction, and migrations and SAEs were common. Further study is needed to clarify optimal decompressive strategy, FCSEMS design, and patient selection. (Clinical trial registration number: NCT02802020.)., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. All rights reserved.)

Measuring the adenoma detection rate (ADR) is critical to providing quality care, however it is also challenging. We aimed to develop a tool using pre-existing electronic health record (EHR) functions to accurately and easily measure total ADR and to provide real-time feedback for endoscopists. We utilized the Epic EHR. With the help of an Epic analyst, using existing tools, we developed a method by which endoscopy staff could mark whether an adenoma was detected for a given colonoscopy. Using these responses and all colonoscopies performed by the endoscopist recorded in the EHR, ADR was calculated in a report and displayed to endoscopists within the EHR. One endoscopist piloted the tool, and results of the tool were validated against a manual chart review. Over the pilot period the endoscopist performed 145 colonoscopies, of which 78 had adenomas. The tool correctly identified 76/78 colonoscopies with an adenoma and 67/67 of colonoscopies with no adenomas (97.4% sensitivity, 100% specificity, 98% accuracy). There was no difference in ADR as determined by the tool compared to manual review (53.1% vs. 53.8%, p = 0.912). We successfully developed and pilot tested a tool to measure ADR using existing EHR functionality., (© 2022. This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply.)

Background and Aims: The accurate measurement of technical skill in ERCP is essential for endoscopic training, quality assurance, and coaching of this procedure. Hypothesizing that technical skill can be measured by analysis of ERCP videos, we aimed to develop and validate a video-based ERCP skill assessment tool., Methods: Based on review of procedural videos, the task of ERCP was deconstructed into its basic components by an expert panel that developed an initial version of the Bethesda ERCP Skill Assessment Tool (BESAT). Subsequently, 2 modified Delphi panels and 3 validation exercises were conducted with the goal of iteratively refining the tool. Fully crossed generalizability studies investigated the contributions of assessors, ERCP performance, and technical elements to reliability., Results: Twenty-nine technical elements were initially generated from task deconstruction. Ultimately, after iterative refinement, the tool comprised 6 technical elements and 11 subelements. The developmental process achieved consistent improvements in the performance characteristics of the tool with every iteration. For the most recent version of the tool, BESAT-v4, the generalizability coefficient (a reliability index) was .67. Most variance in BESAT scores (43.55%) was attributed to differences in endoscopists' skill, indicating that the tool can reliably differentiate between endoscopists based on video analysis., Conclusions: Video-based assessment of ERCP skill appears to be feasible with a novel instrument that demonstrates favorable validity evidence. Future steps include determining whether the tool can discriminate between endoscopists of varying experience levels and predict important outcomes in clinical practice., (Copyright © 2021 American Society for Gastrointestinal Endoscopy. All rights reserved.)

Introduction: The impact of radiation prescription dose on postoperative complications during standard of care trimodality therapy for operable stage II-III esophageal and gastroesophageal junction cancers has not been established. Methods: We retrospectively reviewed 82 patients with esophageal or gastroesophageal junction cancers treated between 2004 and 2016 with neoadjuvant chemoradiation followed by resection at a single institution. Post-operative complications within 30 days were reviewed and scored using the Comprehensive Complication Index (CCI). Results were compared between patients treated with <50 Gy and ≥ 50 Gy, as well as to published CROSS study neoadjuvant chemoradiation group data (41.4 Gy). Results: Twenty-nine patients were treated with <50 Gy (range 39.6-46.8 Gy) and 53 patients were treated with ≥ 50 Gy (range 50.0-52.5 Gy) delivered using IMRT/VMAT (41%), 3D-CRT (46%), or tomotherapy IMRT (12%). Complication rates and CCI scores between our <50 Gy and ≥ 50 Gy groups were not significantly different. Assuming a normal distribution of the CROSS data, there was no significant difference in CCI scores between the CROSS study neoadjuvant chemoradiation, <50 Gy, or ≥ 50 Gy groups. Rates of pulmonary complications were greater in the CROSS group (50%) than our <50 Gy (38%) or ≥ 50 Gy (30%) groups. Conclusions: In selected esophageal and gastroesophageal junction cancer patients, radiation doses ≥ 50 Gy do not appear to increase 30 day post-operative complication rates. These findings suggest that the use of definitive doses of radiotherapy (50-50.4 Gy) in the neoadjuvant setting may not increase post-operative complications., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Kastelowitz, Marsh, McCarter, Meguid, Bhardwaj, Mitchell, Weyant, Scott, Schefter, Stumpf, Leong, Messersmith, Lieu, Leal, Davis, Purcell, Kane, Wani, Shah, Hammad, Edmundowicz and Goodman.)

Advanced endoscopy training programs (AETPs) were developed as a result of the lack of comprehensive endoscopic retrograde cholangiopancreatography (ERCP) training during gastroenterology fellowships. There is no standardized curriculum for AETPs and the influence of program- and trainer-associated factors on trainee competence in ERCP has not been investigated adequately. In prior work, we showed that advanced endoscopy trainees (AETs) achieve ERCP competence at varying rates. 1,2 The aims of this study were to measure the variability in time given to AETs to attempt cannulation between AETPs and throughout the 1-year training period, and to determine the association between AET cannulation time and AET competence at the end of training., (Copyright © 2020 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background & Aims: There have been few studies describing the long-term durability of complete eradication of intestinal metaplasia (CE-IM) in patients with Barrett's esophagus (BE)-related neoplasia who received endoscopic eradication therapy (EET). Data are needed to guide surveillance interval protocols and identify patients at risk for recurrence. We assessed the rate of recurrence of intestinal metaplasia and dysplasia, histologic features, and outcomes after recurrence of CE-IM, and identified factors associated with recurrence., Methods: We performed a prospective study of 807 patients with BE who underwent EET, which produced CE-IM, at 4 tertiary-care referral centers, from January 2013 to October 2018. Kaplan-Meier estimates of cumulative incidence rates (IR) of recurrence were calculated for up to 5 years following CE-IM and were stratified by baseline level of histology. Density estimates of recurrence were used to determine the change in the rate of recurrence over time. We conducted logistic regression analysis to identify factors associated with recurrence., Results: Intestinal metaplasia recurred in 121 patients (15%; IR, 5.2/100 person-years), and dysplasia recurred in 41 patients (5.1%; IR, 1.8/100 person-years), after a median follow-up time of 2317 person-years. The rate of recurrence was not constant and the time to any recurrence converged to a normal distribution; recurrences peaked at 1.6 y after patients had CE-IM. Baseline high-grade dysplasia or intramucosal cancer (adjusted odds ratio [aOR], 4.19), presence of reflux symptoms (aOR, 12.1) or hiatal hernia (aOR, 13.8), and number of sessions required to achieve CE-IM (aOR, 1.8) were associated with recurrence., Conclusions: In a prospective study of a large cohort of patients with BE undergoing EET, we found a low rate of recurrence after CE-IM. The rate of recurrence peaked at 1-2 y after CE-IM. These findings indicate that aggressive surveillance might not be necessary more than 1 y after CE-IM and should be considered in surveillance guidelines. Clinicaltrials.gov no: NCT02634645., (Copyright © 2020 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Surveillance endoscopy is recommended after endoscopic eradication therapy (EET) for Barrett's esophagus (BE) because of the risk of recurrence. Currently recommended biopsy protocols are based on expert opinion and consist of sampling visible lesions followed by random 4-quadrant biopsy sampling throughout the length of the original BE segment. Despite this protocol, some recurrences are not visibly identified. We aimed to identify the anatomic location and histology of recurrences after successful EET with the goal of developing a more efficient and evidence-based surveillance biopsy protocol., Methods: We performed an analysis of a large multicenter database of 443 patients who underwent EET and achieved complete eradication of intestinal metaplasia (CE-IM) from 2005 to 2015. The endoscopic location of recurrence relative to the squamocolumnar junction (SCJ), visible recurrence identified during surveillance endoscopy, and time to recurrence after CE-IM were assessed., Results: Fifty patients with BE recurrence were studied in the final analysis. Seventeen patients (34%) had nonvisible recurrences. In this group, biopsy specimens demonstrating recurrence were taken from within 2 cm of the SCJ in 16 of these 17 patients (94%). Overall, 49 of 50 recurrences (98%) occurred either within 2 cm of the SCJ or at the site of a visible lesion. Late recurrences (>1 year) were more likely to be visible than early (<1 year) recurrences (P = .006)., Conclusions: Recurrence after EET detected by random biopsy sampling is identified predominately in the distal esophagus and occurs earlier than visible recurrences. As such, we suggest a modified biopsy protocol with targeted sampling of visible lesions followed by random biopsy sampling within 2 cm of the SCJ to optimize detection of recurrence after EET. (Clinical trial registration number: NCT02634645.)., (Copyright © 2019 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background: Iatrogenic perforations related to endoscopic retrograde cholangiopancreatography (ERCP) are rare events, carrying with it a mortality of up to 8%. Given the rarity of this adverse event, there remains limited data and continued uncertainties when choosing therapeutic strategies. Our aims were to evaluate the management of ERCP-related perforations and compare outcomes based on timing of recognition., Methods: The endoscopic databases of two tertiary care centers were interrogated to identify consecutive adult patients who sustained ERCP-related perforation over a 10-year period from 2006 to 2016. Electronic medical records were reviewed to extract demographic data, perforation type, management strategies, clinical data, and patient outcomes., Results: 14,045 ERCP's were performed during our 10-year study period. Sixty-three patients (average age 62.3 ± 2.38 years, 76% female) with ERCP-related perforations were included. Stapfer I perforations were found in 14 (22.2%) patients, Stapfer II in 24 (38.1%), and Stapfer III and IV perforations were identified in 16 (25.4%) and 9 (14.28%), respectively. Forty-seven (74.6%) perforations were recognized immediately during the ERCP, whereas 16 (25.4%) were recognized late. Endoscopic therapy was attempted in 35 patients in whom perforations were identified immediately, and was technically successful in 33 (94.3%). In all, 4 (1 immediate/ 3 delayed) patients required percutaneous drainage and 9 (5 immediate/ 4 delayed) surgery. Length of hospital stay, ICU admission were significantly shorter and incidence of SIRS was significantly lower when perforation was recognized immediately., Conclusions: Immediate recognition of ERCP-related perforations leads to more favorable patient outcomes; with lower incidence of SIRS, less need for ICU level care, and shorter hospital stay.

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/m 2 , 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/m 2 (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., (Copyright © 2018 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)

Background & Aims: There have been few studies that compared the effects of lumen-apposing metal stents (LAMS) and double-pigtail plastic stents (DPS) in patients with peripancreatic fluid collections from pancreatitis. We aimed to compare technical and clinical success and adverse events in patients who received LAMS vs DPS for pancreatic pseudocysts and walled-off necrosis., Methods: We performed a retrospective study of endoscopic ultrasound-mediated drainage in 149 patients (65% male; mean age, 47 y) with pancreatic pseudocysts or walled-off necrosis (97 received LAMS and 152 received DPS), from January 2011 through September 2016 at a single center. We collected data on patient characteristics, outcomes, hospitalizations, and imaging findings. Technical success was defined as LAMS insertion or a minimum of 2 DPS. Clinical success was defined as resolution of pancreatic pseudocysts or walled-off necrosis based on imaging results. The primary outcome was resolution of peripancreatic fluid collection with reduced abdominal pain or obstructive signs or symptoms. Secondary outcomes included the identification and management of adverse events, number of additional procedures required to resolve fluid collection, and the recurrence of fluid collection., Results: Patients who received LAMS had larger peripancreatic fluid collections than patients who received DPS prior to intervention (P = .001), and underwent an average 1.7 interventions vs 1.9 interventions for patients who received DPS (P = .93). Technical success was achieved for 90 patients with LAMS (92.8%) vs 137 patients with DPS (90.1%) (odds ratio [OR] for success with DPS, 0.82; 95% CI, 0.33-2.0; P = .67). Despite larger fluid collections in the LAMS group, there was no significant difference in proportions of patients with clinical success following placement of LAMS (82 of 84 patients, 97.6%) vs DPS (118 of 122 patients, 96.7%) (OR for clinical success with DPS, 0.73; 95% CI, 0.13-4.0; P = .71). Adverse events developed in 24 patients who received LAMS (24.7%) vs 27 patients who received DPS (17.8%) (OR for an adverse event in a patient receiving a DPS, 0.82; 95% CI, 0.33-2.0; P = .67). However, patients with LAMS had a higher risk of pseudoaneurysm bleeding than patients with DPS (OR, 10.0; 95% CI, 1.19-84.6; P = .009)., Conclusions: In a retrospective study of patients undergoing drainage of pancreatic pseudocysts or walled-off necrosis, we found LAMS and DPS to have comparable rates of technical and clinical success and adverse events. Drainage of walled-off necrosis or pancreatic pseudocysts using DPS was associated with fewer bleeding events overall, including pseudoaneurysm bleeding, but bleeding risk with LAMS should be weighed against the trend of higher actionable perforation and infection rates with DPS., (Copyright © 2018 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background & Aims: On the basis of the Next Accreditation System, trainee assessment should occur on a continuous basis with individualized feedback. We aimed to validate endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP) learning curves among advanced endoscopy trainees (AETs) by using a large national sample of training programs and to develop a centralized database that allows assessment of performance in relation to peers., Methods: ASGE recognized training programs were invited to participate, and AETs were graded on ERCP and EUS exams by using a validated competency assessment tool that assesses technical and cognitive competence in a continuous fashion. Grading for each skill was done by using a 4-point scoring system, and a comprehensive data collection and reporting system was built to create learning curves by using cumulative sum analysis. Individual results and benchmarking to peers were shared with AETs and trainers quarterly., Results: Of the 62 programs invited, 20 programs and 22 AETs participated in this study. At the end of training, median number of EUS and ERCP performed/AET was 300 (range, 155-650) and 350 (125-500), respectively. Overall, 3786 exams were graded (EUS, 1137; ERCP-biliary, 2280; ERCP-pancreatic, 369). Learning curves for individual end points and overall technical/cognitive aspects in EUS and ERCP demonstrated substantial variability and were successfully shared with all programs. The majority of trainees achieved overall technical (EUS, 82%; ERCP, 60%) and cognitive (EUS, 76%; ERCP, 100%) competence at conclusion of training., Conclusions: These results demonstrate the feasibility of establishing a centralized database to report individualized learning curves and confirm the substantial variability in time to achieve competence among AETs in EUS and ERCP. ClinicalTrials.gov: NCT02509416., (Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background & Aims: It is not clear exactly how many passes are required to determine whether pancreatic masses are malignant using endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA). We aimed to define the per-pass diagnostic yield of EUS-FNA for establishing the malignancy of a pancreatic mass, and identify factors associated with detection of malignancies., Methods: In a prospective study, 239 patients with solid pancreatic masses were randomly assigned to groups that underwent EUS-FNA, with the number of passes determined by an on-site cytopathology evaluation or set at 7 passes, at 3 tertiary referral centers. A final diagnosis of pancreatic malignancy was made based on findings from cytology, surgery, or a follow-up evaluation at least 1 year after EUS-FNA. The cumulative sensitivity of detection of malignancy by EUS-FNA was calculated after each pass; in the primary analysis, lesions categorized as malignant or suspicious were considered as positive findings., Results: Pancreatic malignancies were found in 202 patients (84.5% of the study population). EUS-FNA detected malignancies with 96% sensitivity (95% confidence interval [CI], 92%-98%); 4 passes of EUS-FNA detected malignancies with 92% sensitivity (95% CI, 87%-95%). Tumor size greater than 2 cm was the only variable associated with positive results from cytology analysis (odds ratio, 7.8; 95% CI, 1.9-31.6). In masses larger than 2 cm, 4 passes of EUS-FNA detected malignancies with 93% sensitivity (95% CI, 89%-96%) and in masses ≤2 cm, 6 passes was associated with 82% sensitivity (95% CI, 61%-93%). Sensitivity of detection did not increase with increasing number of passes., Conclusions: In a prospective study, we found 4 passes of EUS-FNA to be sufficient to detect malignant pancreatic masses; increasing the number of passes did not increase the sensitivity of detection. Tumor size greater than 2 cm was associated with malignancy, and a greater number of passes may be required to evaluate masses 2 cm or less. ClinicalTrials.gov number, NCT01386931., (Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Objectives: The AspireAssist System (AspireAssist) is an endoscopic weight loss device that is comprised of an endoscopically placed percutaneous gastrostomy tube and an external device to facilitate drainage of about 30% of the calories consumed in a meal, in conjunction with lifestyle (diet and exercise) counseling., Methods: In this 52-week clinical trial, 207 participants with a body-mass index (BMI) of 35.0-55.0 kg/m 2 were randomly assigned in a 2:1 ratio to treatment with AspireAssist plus Lifestyle Counseling (n=137; mean BMI was 42.2±5.1 kg/m 2 ) or Lifestyle Counseling alone (n=70; mean BMI was 40.9±3.9 kg/m 2 ). The co-primary end points were mean percent excess weight loss and the proportion of participants who achieved at least a 25% excess weight loss., Results: At 52 weeks, participants in the AspireAssist group, on a modified intent-to-treat basis, had lost a mean (±s.d.) of 31.5±26.7% of their excess body weight (12.1±9.6% total body weight), whereas those in the Lifestyle Counseling group had lost a mean of 9.8±15.5% of their excess body weight (3.5±6.0% total body weight) (P<0.001). A total of 58.6% of participants in the AspireAssist group and 15.3% of participants in the Lifestyle Counseling group lost at least 25% of their excess body weight (P<0.001). The most frequently reported adverse events were abdominal pain and discomfort in the perioperative period and peristomal granulation tissue and peristomal irritation in the postoperative period. Serious adverse events were reported in 3.6% of participants in the AspireAssist group., Conclusions: The AspireAssist System was associated with greater weight loss than Lifestyle Counseling alone.

Background & Aims: Multiple endoscopic bariatric therapies (EBTs) currently are being evaluated or are in clinical use in the United States. EBTs are well positioned to fill an important gap in the management of obesity and metabolic disease. The purpose of this expert review is to update gastroenterologists on these therapies and provide practice advice on how to incorporate them into clinical practice., Methods: The evidence reviewed in this work is a distillation of comprehensive search of several English-language databases and a manual review of relevant publications (including systematic reviews and meeting abstracts). Best Practice Advice 1: EBTs should be considered in patients with obesity who have been unsuccessful in losing or maintaining weight loss with lifestyle interventions. Best Practice Advice 2: EBTs can be used in patients with severe obesity as a bridge to traditional bariatric surgery. They also can be used as a bridge to allow unrelated interventions that are unable to be performed because of weight limits (ie, orthopedic surgery, organ transplantation). Best Practice Advice 3: Clinicians should use EBTs as part of a structured weight loss program that includes dietary intervention, exercise therapy, and behavior modification, in both the active weight loss phase and the long-term maintenance phase. Best Practice Advice 4: Clinicians should screen all potential EBT candidates with a comprehensive evaluation for medical conditions, comorbidities, and psychosocial or behavioral patterns that contribute to their condition before enrolling patients in a weight loss program that includes EBTs. Best Practice Advice 5: Clinicians incorporating EBTs into their clinical practice should follow up patients prospectively to capture the impact of the EBT program on weight and weight-related comorbidities, and all related adverse outcomes. Poor responders should be identified and offered a detailed evaluation and alternative therapy. Best Practice Advice 6: Clinicians embarking on incorporating EBTs into their clinical practice should have a comprehensive knowledge of the indications, contraindications, risks, benefits, and outcomes of individual EBTs, as well as a practical knowledge of the risks and benefits of alternative therapies for obesity. Best Practice Advice 7: Institutions should establish specific guidelines that are applied consistently across disciplines for granting privileges in EBTs that reflect the necessary knowledge and technical skill a clinician must achieve before being granted privileges to perform these procedures., (Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background: Saline-filled intragastric balloon devices are reversible endoscopic devices designed to occupy stomach volume and reduce food intake., Objective: To evaluate the safety and effectiveness of a dual balloon system plus diet and exercise in the treatment of obesity compared to diet and exercise alone., Setting: Academic and community practice, United States., Methods: Participants (n = 326) with body mass index (BMI) 30-40 kg/m(2) were randomized to endoscopic DBS treatment plus diet and exercise (DUO, n = 187) or sham endoscopy plus diet and exercise alone (DIET, n = 139). Co-primary endpoints were a between-group comparison of percent excess weight loss (%EWL) and DUO subject responder rate, both at 24 weeks. Thereafter DUO patients had the DBS retrieved followed by 24 additional weeks of counseling; DIET patients were offered DBS treatment., Results: Mean BMI was 35.4. Both primary endpoints were met. DUO weight loss was over twice that of DIET. DUO patients had significantly greater %EWL at 24 weeks (25.1% intent-to-treat (ITT), 27.9% completed cases (CC, n = 167) compared with DIET patients (11.3% ITT, P = .004, 12.3% CC, n = 126). DUO patients significantly exceeded a 35% response rate (49.1% ITT, P<.001, 54.5% CC) for weight loss dichotomized at 25%EWL. Accommodative symptoms abated rapidly with support and medication. Balloon deflation occurred in 6% without migrations. Early retrieval for nonulcer intolerance occurred in 9%. Gastric ulcers were observed; a minor device change led to significantly reduced ulcer size and frequency (10%)., Conclusion: The DBS was significantly more effective than diet and exercise in causing weight loss with a low adverse event profile., (Copyright © 2015 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: The management of complex colorectal polyps varies in practice. Accurate descriptions of the endoscopic appearance by using a standardized classification system (Paris classification) and size for complex colon polyps may guide subsequent providers regarding curative endoscopic resection vs. need for surgery. The accuracy of this assessment is not well defined. Furthermore, the factors associated with decisions for endoscopic vs. surgical management are unclear. To characterize the accuracy of physician assessment of polyp morphology, size, and suspicion for malignancy among physician subspecialists performing colonoscopy and colon surgery. In addition, we aimed to assess the influence of these polyp characteristics as well as physician type and patient demographics on recommendations for endoscopic vs. surgical resection of complex colorectal polyps., Methods: An online video-based survey was sent to gastroenterologists (GIs) and gastrointestinal surgeons affiliated with six tertiary academic centers. The survey consisted of high-definition video clips (30-60 s) of six complex colorectal polyps (one malignant) and clinical histories. Respondents were blinded to histology. Respondents were queried regarding polyp characteristics, suspicion for malignancy, and recommendations for resection., Results: The survey response rate was 154/317 (49%). Seventy-eight percent of respondents were attending physicians (91 GIs and 29 surgeons) and 22% were GI trainees. Sixteen percent of respondents self-identified as specialists in complex polypectomy. Accurate estimation of polyp size was poor (28.4%) with moderate interobserver agreement (k=0.52). Accuracy for Paris classification was 47.5%, also with moderate interobserver agreement (k=0.48). Specialists in complex polypectomy were most accurate, whereas surgeons were the least accurate in assigning Paris classification (66.0 vs. 28.7%, P<0.0001). Specialists in complex polypectomy were most likely to correctly identify the malignant lesion compared with other physicians (87.5 vs. 56.2%, P=0.008). Surgical removal of colon adenomas was recommended least frequently by specialists in complex polypectomy (3.1%) compared with nonspecialists in complex polypectomy (13.3%); surgeons were most likely to recommend surgical resection (17.2%, P=0.009). There were no differences in recommendations for endoscopic vs. surgical resection observed on the basis of years in practice, polyp morphology (polypoid vs. nonpolypoid), polyp location (right vs. left colon), or patient ASA class., Conclusions: In this large survey of GIs and surgeons, physician specialty was strongly associated with accurate polyp characterization and a recommendation for endoscopic resection of complex polyps. Surgeons were most likely to recommend surgical resection of complex nonmalignant colorectal polyps compared with specialists in complex polypectomy who were the least likely. Therefore, collaboration with specialists in complex polypectomy may be helpful in determining the appropriate management of complex colon polyps. Further teaching is needed among all specialists to improve accurate communication and ensure optimal management of these lesions.

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., (Copyright © 2013 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background & Aims: Weight regain or insufficient loss after Roux-en-Y gastric bypass (RYGB) is common. This is partially attributable to dilatation of the gastrojejunostomy (GJ), which diminishes the restrictive capacity of RYGB. Endoluminal interventions for GJ reduction are being explored as alternatives to revision surgery. We performed a randomized, blinded, sham-controlled trial to evaluate weight loss after sutured transoral outlet reduction (TORe)., Methods: Patients with weight regain or inadequate loss after RYGB and GJ diameter greater than 2 cm were assigned randomly to groups that underwent TORe (n = 50) or a sham procedure (controls, n = 27). Intraoperative performance, safety, weight loss, and clinical outcomes were assessed., Results: Subjects who received TORe had a significantly greater mean percentage weight loss from baseline (3.5%; 95% confidence interval, 1.8%-5.3%) than controls (0.4%; 95% confidence interval, 2.3% weight gain to 3.0% weight loss) (P = .021), using a last observation carried forward intent-to-treat analysis. As-treated analysis also showed greater mean percentage weight loss in the TORe group than controls (3.9% and 0.2%, respectively; P = .014). Weight loss or stabilization was achieved in 96% subjects receiving TORe and 78% of controls (P = .019). The TORe group had reduced systolic and diastolic blood pressure (P < .001) and a trend toward improved metabolic indices. In addition, 85% of the TORe group reported compliance with the healthy lifestyle eating program, compared with 53.8% of controls; 83% of TORe subjects said they would undergo the procedure again, and 78% said they would recommend the procedure to a friend. The groups had similar frequencies of adverse events., Conclusions: A multicenter randomized trial provides Level I evidence that TORe reduces weight regain after RYGB. These results were achieved using a superficial suction-based device; greater levels of weight loss could be achieved with newer, full-thickness suturing devices. TORe is one approach to avoid weight regain; a longitudinal multidisciplinary approach with dietary counseling and behavioral changes are required for long-term results. ClinicalTrials.gov identifier: NCT00394212., (Copyright © 2013 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background: American Society for Gastrointestinal Endsocopy (ASGE) guidelines for assessing minimal competence in EUS are based on expert opinion and retrospective studies., Objective: To prospectively define learning curves in EUS among advanced endoscopy trainees (AETs)., Design: Prospective trial., Setting: Three tertiary-care referral centers., Patients: AETs with no prior EUS experience., Intervention: AETs were evaluated by attending endosonographers at intervals of 10 EUS examinations (beginning at the 25th examination) during a 12-month training period. A standardized data collection form was used to grade examination of EUS anatomic stations and, when applicable, lesion of interest, accurate uTNM staging, wall layer origin of subepithelial lesions, and technical success with FNA., Main Outcome Measurements: Cumulative sum analysis was applied to assess competency and produce a learning curve for each trainee for overall performance and for each anatomic station. Acceptable and unacceptable failure rates of 10% and 20%, respectively, were used., Results: Five AETs were included, with a total of 1412 EUS examinations (AET1-225, T2-175, T3-402, T4-315, T5-295). Two AETs crossed the threshold for acceptable performance at cases number 255 and 295, two AETs showed a trend toward acceptable performance after 225 and 196 cases but needed ongoing training, and 1 AET demonstrated the need for ongoing training after 402 cases. Similar variable results were noted for individual stations., Limitations: Results from this study may not be generalizable to other centers' AETs., Conclusion: We observed substantial variability in achieving competency and a consistent need for more supervision in all AETs than current recommendations (150 cases). Future studies should focus on standardization of trainee performance, definition of competency, and widespread applicability of AET evaluation., (Copyright © 2013 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)