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Competing Interests: Disclosure This author disclosed financial relationships: T. H. Baron: Consultant for Boston Scientific, W. L. Gore, and Cook Endoscopy. The other author disclosed no financial relationships. Commentary Here, the authors present an interesting case of using a lumen-apposing metallic stent (LAMS) for the management of splenic necrosis/abscess. Since the introduction of LAMSs for the management of peripancreatic fluid collections, endoscopists have explored their use in a variety of other GI conditions, such as perigastric abscess drainage, GI stricture, anastomotic stricture, and the management of chronic fistula. Although the authors describe a successful case of using a LAMS for the management of a splenic necrosis/abscess, this procedure should be performed with caution because puncturing the splenic capsule could be associated with subcapsular hematoma and devastating bleeding. Also, in cases where the collection is within the center of the spleen, there is a risk of direct injury to the splenic artery if proper assessment with Doppler is not performed during the procedure. As described here, preemptive or concurrent embolization of the splenic artery by international radiology should be performed to limit this life-threatening adverse event. Another issue to consider is that the current available LAMS design has 2 large phalanges to prevent migration—with a larger inner diameter in comparison to the plastic stents. While deploying a stent within a solid cavity, endoscopists may face challenges because the phalanges may not open, not only because of lack of space but also as the result of solid components and higher pressure within the cavity. Although not needed routinely, expansion and liquefying of the necrotic collection with sterile water using an FNA needle can be performed by an experienced endoscopist to ease the procedure. Finally, timely necrosectomy is the key because the job is not done after placing the stent—the journey is long! Perhaps it is safer to avoid keeping the LAMS beyond 4 weeks within the abscess in solid organs to prevent delayed adverse events, such as stent migration and bleeding—although the stent can be kept longer if medically necessary with close observation! Tara Keihanian, MD, MPH, Assistant Professor, Division of Gastroenterology and Hepatology, Baylor College of Medicine, Houston, Texas, USA Amy Tyberg, MD, FASGE, FACG, Associate Editor for Focal Points

Competing Interests: Disclosure The following authors disclosed financial relationships: N. B. Marya: Consultant for Boston Scientific Corporation; food and beverage compensation from Boston Scientific Corporation and Apollo Endosurgery US Inc. S. Pawa: Consultant for Boston Scientific Corporation. N. R. Thiruvengadam: Research support from Boston Scientific Corporation. S. Ngamruengphong: Consultant for Boston Scientific Corporation, Olympus, and Neptune Medical. T. H. Baron: Consultant for Boston Scientific Corporation, Olympus Corporation, Medtronic, Inc, WL Gore & Associates, Inc, Cook Endoscopy, and CONMED Corporation; speaker for Boston Scientific Corporation, Olympus Corporation, Medtronic, Inc, and WL Gore & Associates; travel compensation from CONMED Corporation; food and beverage compensation from Olympus Corporation of the Americas, Ambu, Inc, Boston Scientific Corporation, and Cook Medical LLC. A. Y. B. Teoh: Consultant for Boston Scientific Corporation, Cook Medical LLC, Taewoong and Microtech, MI Tech, and CMR Medical Corporations. W. Abidi: Consultant for Ambu Inc, Apollo Endosurgery US Inc, and CONMED Corporation; research support from GI Dynamics; food and beverage compensation from Ambu Inc, Apollo Endosurgery US Inc, CONMED Corporation, Olympus America Inc, AbbVie Inc, Boston Scientific Corporation, RedHill Biopharma Inc, and Salix Pharmaceuticals. S. K. Amateau: Consultant for Boston Scientific Corporation, Merit Medical, Olympus Corporation of the Americas, MTEndoscopy, US Endoscopy, Heraeus Medical Components, LLC, and Cook Medical LLC; travel compensation from Boston Scientific Corporation; food and beverage compensation from Boston Scientific Corporation, Olympus Corporation of the Americas, and Cook Medical LLC; advisory board for Merit Medical. J. M. Chalhoub: Travel compensation from Olympus Corporation of the Americas; food and beverage compensation from Boston Scientific Corporation. N. Coelho-Prabhu: Consultant for Boston Scientific Corporation and Alexion Pharma; research support from Cook Endoscopy and FujiFilm; food and beverage compensation from Olympus America Inc and Boston Scientific Corporation. N. Cosgrove: Consultant for Olympus Corporation of the Americas and Boston Scientific Corporation; food and beverage compensation from Boston Scientific Corporation and Ambu Inc. S. E. Elhanafi: Food and beverage compensation from Medtronic, Inc, Nestle HealthCare Nutrition Inc, Ambu Inc, Salix Pharmaceuticals, Takeda Pharmaceuticals USA, Inc, and Merit Medical Systems Inc. N. Forbes: Consultant for Boston Scientific Corporation, Pentax of America, Inc, AstraZeneca, and Pendopharm Inc; speaker for Pentax of America, Inc and Boston Scientific Corporation; research support from Pentax of America, Inc. L. L. Fujii-Lau: Food and beverage compensation from Pfizer Inc and AbbVie Inc; consultant for Boston Scientific. D. R. Kohli: Research support from Olympus Corporation of the Americas. J. D. Machicado: Consultant for Mauna Kea Technologies, Inc; food and beverage compensation from Mauna Kea Technologies, Inc and Boston Scientific Corporation. U. Navaneethan: Consultant for ER Squibb & Sons, LLC; travel compensation from ER Squibb & Sons, LLC, Janssen Scientific Affairs, LLC, Takeda Pharmaceuticals USA, Inc, and AbbVie Inc; food and beverage compensation from ER Squibb & Sons, LLC, Janssen Scientific Affairs, LLC, Takeda Pharmaceuticals USA, Inc, AbbVie Inc, Pfizer Inc, Apollo Endosurgery US Inc, Celgene Corporation, and Olympus America Inc; speaker for Janssen Scientific Affairs, LLC, Takeda Pharmaceuticals USA, Inc, AbbVie Inc, and Pfizer Inc. S. G. Sheth: Consulted for Janssen Research & Development, LLC. N. C. Thosani: Consultant for Pentax of America, Inc, Boston Scientific Corporation, and Ambu Inc; travel compensation and food and beverage compensation from Pentax of America, Inc, Boston Scientific Corporation, and AbbVie Inc; speaker for AbbVie Inc. B. J. Qumseya: Consultant for Medtronic, Inc and Assertio Management, LLC; food and beverage compensation from Medtronic, Inc, Fujifilm Healthcare Americas Corporation, and Boston Scientific Corporation; speaker for Castle Biosciences. All other authors disclosed no financial relationships.

This clinical practice guideline from the American Society for Gastrointestinal Endoscopy provides an evidence-based approach for the role of therapeutic EUS in the management of biliary tract disorders. This guideline was developed using the Grading of Recommendations Assessment, Development and Evaluation framework and addresses the following: 1: The role of EUS-guided biliary drainage (EUS-BD) versus percutaneous transhepatic biliary drainage (PTBD) in resolving biliary obstruction in patients after failed ERCP. 2: The role of EUS-guided hepaticogastrostomy versus EUS-guided choledochoduodenostomy in resolving distal malignant biliary obstruction after failed ERCP. 3: The role of EUS-directed transgastric ERCP (EDGE) versus laparoscopic-assisted ERCP and enteroscopy-assisted ERCP (E-ERCP) in resolving biliary obstruction in patients with Roux-en-Y gastric bypass (RYGB) anatomy. 4: The role of EUS-BD versus E-ERCP and PTBD in resolving biliary obstruction in patients with surgically altered anatomy other than RYGB. 5: The role of EUS-guided gallbladder drainage (EUS-GBD) versus percutaneous gallbladder drainage and endoscopic transpapillary transcystic gallbladder drainage in resolving acute cholecystitis in patients who are not candidates for cholecystectomy., Competing Interests: Disclosure The following authors disclosed financial relationships: S. Pawa: Consultant for Boston Scientific Corporation. N. B. Marya: Consultant for Boston Scientific Corporation; food and beverage compensation from Boston Scientific Corporation and Apollo Endosurgery US Inc. N. R. Thiruvengadam: Research support from Boston Scientific Corporation. S. Ngamruengphong: Consultant for Boston Scientific Corporation, Olympus, and Neptune Medical. T. H. Baron: Consultant for Boston Scientific Corporation, Olympus Corporation, Medtronic, Inc, WL Gore & Associates, Inc, Cook Endoscopy, and CONMED Corporation; speaker for Boston Scientific Corporation, Olympus Corporation, Medtronic, Inc, and WL Gore & Associates; travel compensation from CONMED Corporation; food and beverage compensation from Olympus Corporation of the Americas, Ambu, Inc, Boston Scientific Corporation, and Cook Medical LLC. A. Y. B. Teoh: Consultant for Boston Scientific Corporation, Cook Medical LLC, Taewoong and Microtech, MI Tech, and CMR Medical Corporations. W. Abidi: Consultant for Ambu Inc, Apollo Endosurgery US Inc, and CONMED Corporation; research support from GI Dynamics; food and beverage compensation from Ambu Inc, Apollo Endosurgery US Inc, CONMED Corporation, Olympus America Inc, AbbVie Inc, Boston Scientific Corporation, RedHill Biopharma Inc, and Salix Pharmaceuticals. S. K. Amateau: Consultant for Boston Scientific Corporation, Merit Medical, Olympus Corporation of the Americas, MTEndoscopy, US Endoscopy, Heraeus Medical Components, LLC, and Cook Medical LLC; travel compensation from Boston Scientific Corporation; food and beverage compensation from Boston Scientific Corporation, Olympus Corporation of the Americas, and Cook Medical LLC; advisory board for Merit Medical. J. M. Chalhoub: Travel compensation from Olympus Corporation of the Americas; food and beverage compensation from Boston Scientific Corporation. N. Coelho-Prabhu: Consultant for Boston Scientific Corporation and Alexion Pharma; research support from Cook Endoscopy and FujiFilm; food and beverage compensation from Olympus America Inc and Boston Scientific Corporation. N. Cosgrove: Consultant for Olympus Corporation of the Americas and Boston Scientific Corporation; food and beverage compensation from Boston Scientific Corporation and Ambu Inc. S. E. Elhanafi: Food and beverage compensation from Medtronic, Inc, Nestle HealthCare Nutrition Inc, Ambu Inc, Salix Pharmaceuticals, Takeda Pharmaceuticals USA, Inc, and Merit Medical Systems Inc. N. Forbes: Consultant for Boston Scientific Corporation, Pentax of America, Inc, AstraZeneca, and Pendopharm Inc; speaker for Pentax of America, Inc and Boston Scientific Corporation; research support from Pentax of America, Inc. L. L. Fujii-Lau: Food and beverage compensation from Pfizer Inc and AbbVie Inc; consultant for Boston Scientific. D. R. Kohli: Research support from Olympus Corporation of the Americas. J. D. Machicado: Consultant for Mauna Kea Technologies, Inc; food and beverage compensation from Mauna Kea Technologies, Inc and Boston Scientific Corporation. U. Navaneethan: Consultant for ER Squibb & Sons, LLC; travel compensation from ER Squibb & Sons, LLC, Janssen Scientific Affairs, LLC, Takeda Pharmaceuticals USA, Inc, and AbbVie Inc; food and beverage compensation from ER Squibb & Sons, LLC, Janssen Scientific Affairs, LLC, Takeda Pharmaceuticals USA, Inc, AbbVie Inc, Pfizer Inc, Apollo Endosurgery US Inc, Celgene Corporation, and Olympus America Inc; speaker for Janssen Scientific Affairs, LLC, Takeda Pharmaceuticals USA, Inc, AbbVie Inc, and Pfizer Inc. S. G. Sheth: Consulted for Janssen Research & Development, LLC. N. C. Thosani: Consultant for Pentax of America, Inc, Boston Scientific Corporation, and Ambu Inc; travel compensation and food and beverage compensation from Pentax of America, Inc, Boston Scientific Corporation, and AbbVie Inc; speaker for AbbVie Inc. B. J. Qumseya: Consultant for Medtronic, Inc and Assertio Management, LLC; food and beverage compensation from Medtronic, Inc, Fujifilm Healthcare Americas Corporation, and Boston Scientific Corporation; speaker for Castle Biosciences. All other authors disclosed no financial relationships., (Copyright © 2024 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Competing Interests: Disclosure T. H. Baron is a consultant for Cook Endoscopy, Boston Scientific, Olympus, Medtronic, ConMed, and W.L. Gore. All other authors disclosed no financial relationships. Commentary GI perforations, once thought to be a surgical emergency, can now commonly be managed endoscopically, thanks to CO(2) insufflation and improved closure devices such as larger through-the-scope clips, OTSCs, and endoscopic suturing. In this case, a duodenal perforation occurred during advancement of a duodenoscope before ERCP. Rather than aborting the procedure and sending the patient to surgery, the authors were able to successfully close the perforation with an OTSC and then complete the indicated ERCP. Interestingly, a piece of colon was noted to be entrapped within the OTSC after closure, with evidence of tethering of the colon to the duodenum on follow-up imaging. However, the patient experienced no symptoms related to this event and did not require repeated intervention in 6 years of follow-up observation. This case emphasizes not only the efficacy of therapeutic endoscopy in perforation closure but also the importance of using the patient’s symptoms as the most important factor in guiding treatment interventions. Amy Tyberg, MD, FASGE, FACG, Associate Editor for Focal Points

Background and Aims: Palliation of malignant gastric outlet obstruction (mGOO) allows resumption of peroral intake. Although surgical gastrojejunostomy (SGJ) provides durable relief, it may be associated with a higher morbidity, interfere with chemotherapy, and require an optimum nutritional status. EUS-guided gastroenterostomy (EUS-GE) has emerged as a minimally invasive alternative. We aimed to conduct the largest comparative series to date between EUS-GE and SGJ for mGOO., Methods: This multicenter retrospective study included consecutive patients undergoing SGJ or EUS-GE at 6 centers. Primary outcomes included time to resumption of oral intake, length of stay (LOS), and mortality. Secondary outcomes included technical and clinical success, reintervention rates, adverse events (AEs), and resumption of chemotherapy., Results: A total of 310 patients were included (EUS-GE, n = 187; SGJ, n = 123). EUS-GE exhibited significantly lower time to resumption of oral intake (1.40 vs 4.06 days, P < .001), at lower albumin levels (2.95 vs 3.33 g/dL, P < .001), and a shorter LOS (5.31 vs 8.54 days, P < .001) compared with SGJ; there was no difference in mortality (48.1% vs 50.4%, P = .78). Technical (97.9% and 100%) and clinical (94.1% vs 94.3%) success was similar in the EUS-GE and SGJ groups, respectively. EUS-GE had lower rates of AEs (13.4% vs 33.3%, P < .001) but higher reintervention rates (15.5% vs 1.63%, P < .001). EUS-GE patients exhibited significantly lower interval time to resumption of chemotherapy (16.6 vs 37.8 days, P < .001). Outcomes between the EUS-GE and laparoscopic (n = 46) surgical approach showed that EUS-GE had shorter interval time to initiation/resumption of oral intake (3.49 vs 1.46 days, P < .001), decreased LOS (9 vs 5.31 days, P < .001), and a lower rate of AEs (11.9% vs 17.9%, P = .003)., Conclusions: This is the largest study to date showing that EUS-GE can be performed among nutritionally deficient patients without affecting the technical and clinical success compared with SGJ. EUS-GE is associated with fewer AEs while allowing earlier resumption of diet and chemotherapy., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Interventions for malignant small-bowel obstruction (SBO) may be limited by extent of peritoneal disease, rendering surgical or traditional endoscopic methods (ie, luminal stenting or decompressive gastrostomy) unfeasible. We demonstrated the novel use of EUS-guided lumen-apposing metal stent placement for enterocolonic bypass in patients with malignant SBO who were deemed high risk for surgery., Methods: Across 3 tertiary U.S. centers, a retrospective series of consecutive patients underwent attempted EUS-guided enterocolostomy (EUS-EC) for palliation of acute SBO because of malignant causes. Technique and devices used were described, and patient demographics and outcome data were collected., Results: Ten patients were included, of whom 9 (90.0%) were men, with a mean age of 64.5 ± 14.0 years and who were 1.5 ± 2.1 years postdiagnosis. Technical success was achieved in 8 of 10 patients (80.0%) and clinical success in 7 of 10 (70.0%), with a single major adverse event (10.0%) of aspiration. Median time until resumption of oral intake was 1.0 day (range, 0-8) after the procedure, with an interval to discharge home of 6.5 days and survival of 57.0 days., Conclusions: EUS-EC is a new alternative for palliation of acute SBO because of advanced malignant disease when conservative measures fail and other surgical or endoscopic options are not possible. Additional larger studies with longer duration of follow-up are needed to further define efficacy and safety of this approach., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Piecemeal EMR of colorectal laterally spreading tumors (LSTs) >20 mm is effective. Experience is limited in the use of cap-assisted EMR (EMR-C) for resection of colonic lesions. We compared the efficacy and the safety of EMR-C for the removal of colonic LSTs ≥30 mm with "inject-and-cut" standard EMR (EMR-S)., Methods: In this randomized trial from 4 Italian centers, 138 patients were treated with EMR-C and 102 with EMR-S. The rates of residual lesions, percentage of recurrence after 12 months, and adverse events were evaluated., Results: One hundred forty-three lesions were resected with EMR-C and 102 with EMR-S. Argon plasma coagulation (APC) was used as adjunctive treatment in 2.9% of EMR-Cs and in 22.5% of EMR-Ss (P < .001). The median time required was 20 minutes for EMR-C and 30 minutes for EMR-S (P < .001). Adverse events (AEs) occurred in 14 EMR-Cs (10.1%; 2 perforations, 11 bleeding events, and 1 stenosis) and in 22 EMR-Ss (21.6%; 1 perforation and 21 bleeding events) (P = .017). Intraprocedural AEs occurred in 3.6% of EMR-Cs and 16.7% of EMR-Ss (P = .001). Overall, residual lesions within 12 months were found to be significantly higher with EMR-S (32 patients, 31.4%) than with EMR-C (8 patients, 5.8%) (P < .001). Recurrence at follow-up colonoscopy in 12 months occurred in 7 EMR-Cs (5.1%) and 17 EMR-Ss (16.7%; P < .001)., Conclusions: The study demonstrated the feasibility and safety of EMR-C for removing large colorectal LSTs, with higher eradication rates, shorter resection time, and less use of APC when compared with EMR-S. (Clinical trial registration number: NCT03498664.)., (Copyright © 2022 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Endoscopy plays a critical role in caring for and evaluating the patient with eosinophilic esophagitis (EoE). Endoscopy is essential for diagnosis, assessment of response to therapy, treatment of esophageal strictures, and ongoing monitoring of patients in histologic remission. To date, less-invasive testing for identifying or grading EoE severity has not been established, whereas diagnostic endoscopy as integral to both remains the criterion standard. Therapeutic endoscopy in patients with adverse events of EoE may also be required. In particular, dilation may be essential to treat and attenuate progression of the disease in select patients to minimize further fibrosis and stricture formation. Using a modified Delphi consensus process, a group of 20 expert clinicians and investigators in EoE were assembled to provide guidance for the use of endoscopy in EoE. Through an iterative process, the group achieved consensus on 20 statements yielding comprehensive advice on tissue-sampling standards, gross assessment of disease activity, use and performance of endoscopic dilation, and monitoring of disease, despite an absence of high-quality evidence. Key areas of controversy were identified when discussions yielded an inability to reach agreement on the merit of a statement. We expect that with ongoing research, higher-quality evidence will be obtained to enable creation of a guideline for these issues. We further anticipate that forthcoming expert-generated and agreed-on statements will provide valuable practice advice on the role and use of endoscopy in patients with EoE., (Copyright © 2022 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: EUS-guided hepaticogastrostomy has been performed for many years with most published experience from outside the United States. The luminal access point can be from the esophagus, stomach, duodenum, or jejunum; biliary access can be either into the right or left intrahepatic system. Thus, we prefer the term EUS-guided transhepatic biliary drainage (ETBD). We describe what is believed to be the largest single-center U.S. experience of ETBD for management of benign and malignant biliary disease., Methods: This was a retrospective study of all ETBD conducted by 1 endoscopist between September 2014 and May 2021., Results: Two hundred fifteen patients underwent attempted ETBD: 85 for benign disease and 130 for malignant disease. Ninety-two patients (43%) had surgically altered anatomy (SAA). In 94 patients previously endoscopic attempts failed. The approach was transesophageal in 9, transgastric in 188, transduodenal in 5, and transjejunal in 5 patients. In 1 patient a bilateral approach was used. Standard fully covered self-expandable stents of 4- to 10-cm lengths and 8- or 10-mm diameters were used. Technical success was 95.3% and clinical success was 87.25%. Forty patients (18.6%) experienced adverse events (13 mild, 21 moderate, and 6 severe according to the modified American Society for Gastrointestinal Endoscopy lexicon). Mean follow-up was 257.31 ± 308.11 days for all patients (124.53 ± 229.86 days for benign disease and 457.27 ± 466.31 days for malignant disease). Seventy-four patients (34.4%) had died at the time of data collection (66 in the malignant cohort, 8 in the benign cohort). Of those with malignancy surviving >6 months, 17.4% required reintervention., Conclusions: ETBD is effective in the management of benign and malignant biliary obstruction for patients with SAA as well as native anatomy, with a modest adverse event rate., (Copyright © 2022 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

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.)

Background and Aims: Anterograde endoscopic ultrasound-guided pancreatic duct drainage (EUS-PDD) refers to transmural drainage of the main pancreatic duct via an endoprosthesis passed anterograde through the gastric (or intestinal) wall. Anterograde EUS-PDD is a rescue procedure for recalcitrant cases of benign obstructive pancreatopathy., Methods: We conducted a dual-center retrospective chart review of 28 patients (mean age, 59 years; 50% female) who underwent attempted anterograde EUS-PDD between April 2016 and September 2019 for chronic pancreatitis (CP) (93%) or pancreaticojejunostomy stenosis (PJS) after Whipple resection (7%). The study endpoint was achievement of transpapillary/transanastomotic drainage (definitive therapy)., Results: Gastropancreaticoenterostomy (ring drainage, definitive therapy) was successfully performed during the index procedure in the 2 patients with PJS (technical success, 100%). Clinical success was 100% in the 2 ring drainage recipients during a mean 18-month follow-up period. The remaining 26 patients with CP underwent attempted pancreaticogastrostomy (PG) with 81% technical success, 75% clinical success, and 15% adverse events (AEs). Repeat endoscopic transmural interventions were performed in the 15 patients with clinical success after PG creation. Definitive therapy transpired in all 15 patients after a median 1 repeat procedure per patient. Clinical success after definitive therapy was maintained in all 15 patients (100%) during a median 4.5-month follow-up., Conclusions: In agreement with previous studies, our study showed mild to moderately high rates of technical failure (19%), clinical failure (25%), and AEs (15%) during index drainage (PG creation). Among patients with CP with both technical and clinical success after index PG creation (n = 15), 100% definitive therapy was achieved and clinical outcomes were excellent (100% clinical success, 0% AEs)., (Copyright © 2020 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Pancreatic necrosis may be categorized as an acute necrotic collection (ANC) or walled-off necrosis (WON) based on complete encapsulation by a wall and collection age (≤4 weeks or >4 weeks). Endoscopic intervention of WON has become the standard of care, but little is known regarding the safety and efficacy of endoscopic intervention of pancreatic necrosis ≤4 weeks from disease onset., Methods: Retrospective review of medical records and imaging studies of all patients undergoing early endoscopic intervention of pancreatic necrosis between 2008 and 2018 was carried out at 1 referral center. Patients who underwent previous interventional treatment were excluded. Control WON patients were matched to early intervention cases. The primary outcome was defined as resolution of the collection after endoscopic treatment, without surgery., Results: Nineteen patients with early intervention were identified. The most common indication for intervention was infection. Median age of these collections at the time of initial endoscopic intervention was 23 days (range, 15-27 days), and all collections had a partial or complete wall discernable on contrast-enhanced CT. Eleven patients underwent concurrent endoscopic necrosectomy. The primary outcome was achieved in all patients in the early intervention group. Total duration of therapy was longer for early intervention compared with controls (103 vs 69 days, P = .042), with no mortality and similar adverse event rates compared with controls., Conclusions: Endoscopic intervention of pancreatic necrosis in the third and fourth weeks of illness appears effective and safe when a partial collection wall is present on cross-sectional imaging studies, with outcomes paralleling those reported for intervention of WON., (Copyright © 2020 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Enteroscopy-assisted ERCP is challenging in patients with surgically altered upper GI anatomy. This study evaluated a novel procedure, EUS-directed transenteric ERCP (EDEE), in the de novo creation of an enteroenteric anastomosis for the performance of ERCP in non-Roux-en Y gastric bypass (RYGB) patients., Methods: This was a multicenter retrospective study involving 7 centers between January 2014 and October 2018. Primary outcome was clinical success (completion of EDEE and ERCP with intended interventions), and secondary outcomes were technical success and rate/severity of adverse events., Results: Eighteen patients (mean age, 63 years; 13 women) were included. The most common type of surgical anatomy was Whipple (10/18) and Roux-en-Y hepaticojejunostomy (6/18). Technical success rate of EUS-guided lumen-apposing metal stent (LAMS) placement was 100% and of ERCP was 94.44% (17/18). Fourteen patients underwent separate-session EDEE with a median of 21 days (interquartile range [IQR], 11.5-36) between the 2 procedures. Median total procedure time was 111 minutes (IQR, 81-192). Clinical success and adverse events occurred in 17 (94.4%) and 1 (5.6%; abdominal pain) patients, respectively, during a median follow-up of 88 days (IQR, 54-142)., Conclusions: This study suggests that EDEE using LAMSs is feasible and safe in patients with non-RYGB surgical anatomy and complex pancreaticobiliary pathologies., (Copyright © 2020 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Benign gastric outlet obstruction (GOO) has typically been managed surgically. However, many patients are poor operative candidates because of comorbidities. EUS-guided gastroenterostomy (EUS-GE) using lumen-apposing metal stents (LAMSs) has previously demonstrated efficacy as a definitive treatment for benign and malignant GOO; however, limited data exist on use as a bridge to resolution of the obstruction in an attempt to avoid or delay definitive surgery., Methods: A retrospective series of consecutive patients who underwent EUS-GE between January 2013 and July 2019 for benign GOO at a tertiary referral center were included in the study. The primary outcome was the rate of definitive surgery; secondary outcomes included technical success and rate of adverse events., Results: During the study period, 22 patients with benign GOO underwent EUS-GE (40% female; mean age, 54.2 years). The mean procedure time was 66 minutes, and technical success was achieved in 21. Five patients developed recurrent GOO while the LAMS was in place after a mean dwell time of 228 days; 1 patient was converted to surgical GE. LAMSs were removed electively in 18 patients after GOO resolution and a mean dwell time of 270 days; 1 patient developed a recurrent GOO after LAMS removal and was converted to surgical GE. The rate of recurrent GOO after LAMS removal was 5.6%. Three severe adverse events occurred in the cohort., Conclusions: EUS-GE was able to prevent surgery for GOO in 83.3% of cases. LAMSs needed to stay in place for a mean of 8.5 months to allow resolution of GOO, and there was a low rate of recurrent GOO (5.6%) after LAMS removal. Prospective, randomized trials comparing surgical and endoscopic anastomoses are needed in patients with benign causes of GOO., (Copyright © 2020 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Pancreatic cysts are common and often incidentally detected on abdominal imaging. Their prevalence in asymptomatic individuals depends on the screening modality used. The incidence of these lesions increases with age and may be detected in nearly half of elderly patients undergoing high-resolution magnetic resonance imaging. Some, but not all, pancreas cysts have malignant potential. The overall risk is small but induces significant anxiety for the patient. When determining management options, it is important to consider the patient's age, medical comorbidities, and surgical risks as well as the wishes of the patient. Current strategies include imaging surveillance or surgical resection. Before embarking on cyst surveillance, a clinician must factor in patients' risk of developing malignancy, their life expectancy, medical comorbidities, and if they are a surgical candidate. Surgery poses significant adverse events and mortality, whereas radiographic surveillance imposes healthcare costs and psychological distress to patients with the looming possibility of malignancy. The development and use of endoscopic ultrasound cyst ablation is a minimally invasive alternative in treating pancreatic cystic lesions. This review focuses on the modalities of ethanol ablation, paclitaxel ablation, and radiofrequency ablation of pancreatic cystic lesions., (Copyright © 2020. Published by Elsevier Inc.)

Background and Aims: Minimum EUS and ERCP volumes that should be offered per trainee in "high quality" advanced endoscopy training programs (AETPs) are not established. We aimed to define the number of procedures required by an "average" advanced endoscopy trainee (AET) to achieve competence in technical and cognitive EUS and ERCP tasks to help structure AETPs., Methods: American Society for Gastrointestinal Endoscopy (ASGE)-recognized AETPs were invited to participate; AETs were graded on every fifth EUS and ERCP examination using a validated tool. Grading for each skill was done using a 4-point scoring system, and learning curves using cumulative sum analysis for overall, technical, and cognitive components of EUS and ERCP were shared with AETs and trainers quarterly. Generalized linear mixed-effects models with a random intercept for each AET were used to generate aggregate learning curves, allowing us to use data from all AETs to estimate the average learning experience for trainees., Results: Among 62 invited AETPs, 37 AETs from 32 AETPs participated. Most AETs reported hands-on EUS (52%, median 20 cases) and ERCP (68%, median 50 cases) experience before starting an AETP. The median number of EUS and ERCPs performed per AET was 400 (range, 200-750) and 361 (range, 250-650), respectively. Overall, 2616 examinations were graded (EUS, 1277; ERCP-biliary, 1143; pancreatic, 196). Most graded EUS examinations were performed for pancreatobiliary indications (69.9%) and ERCP examinations for ASGE biliary grade of difficulty 1 (72.1%). The average AET achieved competence in core EUS and ERCP skills at approximately 225 and 250 cases, respectively. However, overall technical competence was achieved for grade 2 ERCP at about 300 cases., Conclusion: The thresholds provided for an average AET to achieve competence in EUS and ERCP may be used by the ASGE and AETPs in establishing the minimal standards for case volume exposure for AETs during their training. (Clinical trial registration number: NCT02509416.)., (Copyright © 2019 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: EUS-guided hepaticoenterostomy (EUS-HE) usually is reserved for palliation of malignant biliary obstruction after failed endoscopic retrograde cholangiography (ERC) or inaccessible biliary tree in surgically altered anatomy (SAA). We describe the outcome of EUS-HE and antegrade therapy for benign biliary disease in patients with SAA., Methods: Retrospective review of 20 consecutive patients with surgically altered anatomy and benign biliary obstruction who underwent EUS-HE performed by 1 endoscopist at a tertiary-care center over a 3-year period., Results: During the study period, 37 patients underwent EUS-HE; 24 for benign disease. Of these, 20 patients had SAA and were analyzed (15 women, mean age, 62 years). SAA consisted of 9 Roux-en-Y gastric bypasses, 6 Roux-en-Y hepaticojejunostomy, 2 Billroth II procedures, and 3 Whipple procedures. Indications for ERC were common bile duct stones (n = 8), benign postoperative strictures (n = 7), chronic pancreatitis (n = 3), inflammatory stricture (n = 1), and treatment of a bile leak (n = 1). Five patients had previously failed balloon enteroscopy-assisted ERCs. The approach was transgastric in 15 and transjejunal in 5. In all cases, a branch of the left hepatic duct with a mean diameter of 7.8 mm was accessed. Median stent length was 80 mm, with diameters of 8 or 10 mm. Antegrade, definitive endoscopic therapy via the HE was performed in 18 patients, with an average of 2.7 procedures performed for resolution of stones and/or downstream strictures. HE stents were removed in 17 patients after a mean of 91 days without adverse events. Three patients experienced mild adverse events (1 with postprocedural pancreatitis after placement of a 10F transpapillary stent, 1 with postprocedural abdominal pain, and 1 with postprocedural cholangitis) requiring hospitalization for fewer than 3 nights; no severe adverse events occurred. The average postprocedural hospital stay was 1.3 days. No deaths occurred during follow-up., Conclusions: EUS-HE is safe and effective in the management of benign biliary obstruction in patients with surgically altered anatomy. It creates a portal to allow definitive, antegrade therapy and is a viable alternative to other endoscopic methods in this patient population., (Copyright © 2018 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Self-expandable metal stents (SEMSs) are used to relieve malignant biliary obstructions. We aimed to compare stent patency, the adverse events rate, and overall survival of covered versus uncovered self-conformable metal stents in patients with primary malignant extrahepatic biliary strictures, not eligible for surgery., Methods: This is a multicenter randomized trial analyzing 158 patients with inoperable distal malignant biliary obstruction conducted in 5 Italian referral centers between December 2014 and October 2016. Seventy-eight patients were randomized to receive a fully covered SEMS (FCSEMS), and 80 patients received uncovered SEMSs (USEMSs). Data from 148 (72 FCSEMSs and 76 USEMSs) of 158 patients were analyzed., Results: Median time of stent patency was lower for FCSEMSs (240 days vs 541 days for USEMSs; P = .031). Adverse events occurred with 19 FCSEMSs (26.4%) and 10 USEMSs (13.2%); P = .061. The main causes of FCSEMS dysfunction were migration (7% vs 0% in the USEMS group) and early occlusion mainly because of sludge or overgrowth; late stent occlusion because of tumor ingrowth occurred in 13.2% of patients in the USEMS group. There were no significant differences either in levels of conjugated bilirubin improvement or in overall survival between the FCSEMS and USEMS groups. Median survival was 134 days in the FCSEMS group and 112 days in the USEMS group (P = .23)., Conclusion: The number of stent-related adverse events was higher, although not significantly, among patients in the FCSEMS group. FCSEMSs had a significantly higher rate of migration than USEMSs, and stent occlusion occurred earlier. A significant difference in the patency rate was observed in favor of the USEMS group. (Clinical trial registration number: NCT02102984.)., (Copyright © 2018 American Society for Gastrointestinal Endoscopy. All rights reserved.)

Background: EUS-guided gastroenterostomy (EUS-GE) is a developing modality in the management of gastric outlet obstruction (GOO) with several technical approaches, including the direct and balloon-assisted techniques. The aim of this study was to compare the direct with the balloon-assisted modality while further defining the role of EUS-GE in GOO., Methods: This multicenter, retrospective study involved consecutive patients who underwent EUS-GE with the direct or balloon-assisted technique for GOO (January 2014 to October 2016). The primary outcome was technical success. Secondary outcomes were success (ability to tolerate at least a full fluid diet), procedure time, and rate/severity of adverse events (AEs)., Results: A total of 74 patients (44.6% women; mean age 63.0 ± 11.7 years) underwent EUS-GE for GOO (direct gastroenterostomy, n = 52; balloon-assisted gastroenterostomy, n = 22). GOO was of malignant and benign etiology in 66.2% and 33.8% of patients, respectively. Technical success was achieved in 94.2% of the direct and 90.9% of the balloon-assisted approach (P = .63). Mean procedure time was shorter with the direct technique (35.7 ± 32.1 minutes vs 89.9 ± 33.3 minutes, P < .001). The clinical success rate was 92.3% for the direct technique and 90.9% for the balloon-assisted modality (P = 1.00), with a mean time to oral intake of 1.32 ± 2.76 days. The AE rate was 6.8% with only 1 severe AE noted. Rate of AEs, postprocedure length of stay, need for reintervention, and survival were similar between the 2 groups., Conclusions: EUS-GE is effective and safe in the management of GOO. The direct technique may be the preferred method given its shorter procedure time when compared with the balloon-assisted approach. Prospective trials are needed to confirm these findings., (Copyright © 2018 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Two second-generation, flexible EUS fine-needle biopsy (FNB) needles have been marketed recently in the United States. Thus far, there have been no comparative studies of the diagnostic yield of these needles. The aim of this study was to compare the diagnostic yield achieved with FNB by using 1 needle during 1 time period and the other needle during a second time period., Methods: Consecutive patients with solid lesions undergoing EUS-FNB by using 1 of two 22-gauge FNB needles (Franseen needle or fork-tip) at 2 different time intervals were included. The final diagnosis was based on positive pathology results. In cases of a negative pathology result, the final diagnosis was based on clinical and imaging follow-up., Results: A total of 194 lesions (97 in each group) were sampled in 179 patients. Rapid on-site evaluation (ROSE) was used in 12% of cases. The overall diagnostic yield was lower in the Franseen needle group compared with the fork-tip needle group (61/97 [63%] vs 75/97 [77%], odds ratio (OR) 2.01, 1.07-3.8; P = .027). Similarly, subanalysis of the yield for solid pancreatic masses demonstrated a lower yield with the Franseen needle (34/53 [64%] vs 40/47 [85%], OR 3.4, 9.1-8.9; P = .017). Multivariate analysis controlling for the number of passes, site, and lesion size did not have any effect on diagnostic yield. There were no adverse events in either group., Conclusion: In this first, large, single-center comparative cohort study of 2 new, second-generation EUS-FNB needles of different design, the diagnostic yield when used primarily without ROSE was high in both groups but was significantly higher when a fork-tip needle was used., (Copyright © 2018 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: EUS-guided fine-needle core biopsy sampling is a safe and effective technique for diagnosis of focal liver lesions. However, data are limited in its role in parenchymal disease. We evaluated the utility of EUS-guided parenchymal liver biopsy sampling with a modified 1-pass wet suction technique (EUS-modified liver biopsy sampling [EUS-MLB]) in patients with unexplained increase in liver-associated tests., Methods: We retrospectively evaluated the safety and efficacy of EUS-MLB in patients referred for EUS to evaluate for biliary obstruction and pancreatic disorders but with associated unexplained liver tests. EUS-MLB was performed during the same session after biliary obstruction was excluded., Results: One hundred sixty-five consecutive patients underwent EUS-MLB. The median age was 52 years (interquartile range [IQR], 42-65). Sixty-eight patients (41%) were men. The median of the maximum intact core tissue length was 2.4 cm (IQR, 1.8-3.5). The median total specimen length (TSL) was 6 cm (IQR, 4.3-8). The median number of complete portal tracts (CPTs) per TSL was 18 (IQR, 13- 24). The mean number of CPTs per sample length was 7.5 cm. Adverse events were uncommon (1.8%) and included abdominal pain and self-limited hematoma., Conclusions: EUS-guided fine-needle biopsy sampling using a novel 19-gauge core needle with a modified 1-pass 1 actuation wet suction technique (EUS-MLB) is a safe and effective way to evaluate patients with unexplained liver tests abnormalities who are undergoing EUS for exclusion of biliary obstruction., (Copyright © 2018 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Symptomatic pancreatic walled-off necrosis (WON) may be managed by endoscopic transmural drainage and endoscopic transmural necrosectomy, with stent placement at endoscopic drainage sites. The optimal stent choice is yet to be determined. We compared outcomes after endoscopic management of WON using either large-caliber fully covered self-expandable metal stents (LC-SEMSs) or double-pigtail plastic stents (DPPSs)., Methods: We performed a retrospective comparison of outcomes among patients who received LC-SEMSs or DPPSs before endoscopic transmural necrosectomy for WON., Results: Among 94 patients included, WON resolution rates did not differ between the DPPS (36 patients) and LC-SEMS (58 patients) groups, whether concomitant percutaneous drainage was considered a failure (75% vs 82.8%; P = .36) or not (91.7% vs 94.8%; P = .55). Of 75 patients (80%) successfully treated without percutaneous drainage, 37 (49%) underwent endoscopic transmural drainage without subsequent endoscopic transmural necrosectomy. WON was more likely to resolve without subsequent endoscopic transmural necrosectomy in the LC-SEMS group than the DPPS group (60.4% vs 30.8%; P = .01). WON resolution without subsequent endoscopic transmural necrosectomy remained more likely with LC-SEMSs (odds ratio, 4.5 [95% confidence interval, 1.5-15.5]) after adjusting for patient age and size and location of WON. Rates of adverse events were similar except for clinically significant bleeding requiring endoscopic intervention, which was higher with DPPSs than LC-SEMSs (14% vs 2%; P = .02)., Conclusion: Management of pancreatic WON with LC-SEMSs appears to decrease both the need for repeated necrosectomy procedures and the risk of intervention-related hemorrhage., (Copyright © 2018 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Despite evidence that most nonmalignant colorectal polyps can be managed endoscopically, a substantial proportion of patients with a nonmalignant colorectal polyp are still sent to surgery. Risks associated with this surgery are not well characterized. We describe 30-day postoperative morbidity and mortality and explore risk factors for adverse events in patients undergoing surgical resection for nonmalignant colorectal polyps., Methods: We analyzed data collected prospectively as part of the National Surgical Quality Improvement Program. Our analysis included 12,732 patients who underwent elective surgery for a nonmalignant colorectal polyp from 2011 through 2014. We report adverse events within 30 days of the index surgery. Modified Poisson regression was used to estimate risk ratios and 95% confidence intervals., Results: Thirty-day mortality was .7%. The risk of a major postoperative adverse event was 14%. Within 30 days of resection, 7.8% of patients were readmitted and 3.6% of patients had a second major surgery. The index surgery resulted in a colostomy in 1.8% and ileostomy in .4% of patients. Patients who had surgical resection of a nonmalignant polyp in the rectum or anal canal compared with the colon had a risk ratio of 1.58 (95% confidence interval, 1.09-2.28) for surgical site infection and 6.51 (95% confidence interval, 4.97-8.52) for ostomy., Conclusions: Surgery for a nonmalignant colorectal polyp is associated with significant morbidity and mortality. A better understanding of the risks and benefits associated with surgical management of nonmalignant colorectal polyps will better inform discussions regarding the relative merits of management strategies., (Copyright © 2018 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Extension of ampullary adenomas into the common bile duct (CBD) or pancreatic duct (PD) may be difficult to treat endoscopically. We evaluated the feasibility, safety, and efficacy of endoscopic radiofrequency ablation (RFA) in the management of ampullary neoplasms with intraductal extension., Methods: This was a multicenter, retrospective analysis of all patients with intraductal extension of ampullary neoplasms treated with endoscopic RFA between February 2012 and June 2015. Treatment success was defined as the absence of detectable intraductal polyps by ductography, visual inspection, and biopsy sampling., Results: Fourteen patients with adenoma extension into the CBD (13 ± 7 mm, n = 14) and PD (7 ± 2 mm, n = 3) underwent a median of 1 RFA sessions (range, 1-5). Additional modalities (thermal probes, argon plasma coagulation, and/or photodynamic therapy) were also used in 7 patients, and prophylactic stents were routinely placed. Thirteen assessable patients underwent a median of 2 surveillance ERCPs after completion of treatment over a median follow-up of 16 months (range, 5-46), with intraductal biopsy specimens showing no neoplasm in 12 patients at the conclusion of endoscopic treatment. Treatment success was achieved in 92%, including 100% of those treated with RFA alone. Adverse events occurred in 43% and included ductal strictures (5 patients) and retroduodenal abscess (1 patient), all of which were successfully treated endoscopically., Conclusions: Endoscopic RFA, alone or in combination with other modalities, may effectively treat intraductal extension of ampullary neoplasms. Ductal strictures were common after RFA but responded to endoscopic stent therapy. RFA may be appropriate in selected patients, particularly when the main treatment alternative is pancreaticoduodenectomy., (Copyright © 2017 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Benign GI strictures occur typically in the esophagus and pyloric channel but can occur anywhere in the GI tract and at anastomotic sites. Such strictures can be treated with dilation, incisional therapy, steroid injection, and stents. Our aim was to describe the use of a lumen-apposing metal stent (LAMS) to treat short, benign GI strictures., Patients and Methods: Consecutive patients who underwent LAMS placement for various benign strictures at 2 tertiary care centers from August 2014 to November 2015 were reviewed retrospectively. The main outcome measures were technical success, clinical success, stent migration, and adverse events., Results: Twenty-five patients (7 males, 18 females) with a median age of 54 years (33-85 years) underwent 28 LAMS placements to treat various benign strictures. The location of the strictures included esophagogastric anastomoses (n=4), gastrojejunal anastomoses (n=13), pylorus (n=6), vertical banded gastroplasty (n=1), and ileocolonic anastomosis (n=1). Twenty patients had been previously treated with dilation alone (9 patients with ≥3 dilations), 11 patients with dilation and steroid injection, 2 patients with additional needle-knife therapy, and 1 patient with placement of a traditional fully covered self-expandable metal stent. A 15-mm internal diameter LAMS was placed in all patients; 3 patients had been treated previously with a 10-mm LAMS. Technical success was achieved in all patients, whereas clinical success was achieved in 15 of 25 patients (60%) who completed a minimum of 6 months of follow-up after placement. Median stent dwell time was 92 days (range, 3-273 days). Stent migration was seen in 2 of 28 stent placements (7%). Four of 25 patients (16%) developed 5 moderate adverse events (pain requiring removal, 2; new stricture formation, 2; bleeding, 1). Median follow-up was 301 days after stent placement. Study limitations include the small, select group of patients, the retrospective study design, and short follow-up., Conclusions: LAMS placement for benign GI strictures is technically easy and safe with low migration rates and may be an option to treat selected patients with short-length strictures., (Copyright © 2017 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Although the rule of 3 is recommended to minimize the risk of perforation when esophageal dilation is performed using bougie dilators, there are no data to validate its use. Our aim was to investigate the association between the rule of 3 and adverse events (AEs) in esophageal dilation., Methods: A retrospective chart review in patients who underwent esophageal bougie or balloon dilation between December 1991 and February 2013 at a tertiary hospital was performed. Data collection included patient demographics, stricture and procedural characteristics, AEs, and follow-up. Univariate logistic regression models were used to assess the risk of AEs and perforations., Results: A total of 297 patients (median age, 63 years; 60% men) underwent 2216 esophageal bougie or balloon dilations. Major AEs occurred in 22 (1%) dilation sessions, including 11 (0.5%) perforations, 4 (0.2%) fistulas, 3 (0.1%) hospitalizations for pain management, 2 (0.09%) clinically significant hemorrhages, 1 (0.04%) fever, and 1 (0.04%) tracheoesophageal voice prosthesis leak. Mean duration of treatment was 43.2 months (standard deviation, 47.7 months). Most strictures were benign (n = 275; 93%) and complex in nature (n = 198; 67%). Non-adherence to the rule of 3 occurred in 190 (13%) dilations with bougie dilators. Non-adherence was not associated with a higher rate of major AEs (1/190, 0.5% vs 15/953, 1.6%; P = .18) and perforations (0/190, 0% vs 7/952, 0.7%; P = .18). Gender, complex strictures, location of the stricture, type of dilator, and additional interventions were also not associated with major AEs or perforations. However, malignant strictures were associated with an increased risk of major AEs (odds ratio, 3.5; 95% confidence interval, 1.1-12.0) and perforations (odds ratio, 8.3; 95% confidence interval, 2.2-31.9)., Conclusions: Non-adherence to the rule of 3 does not appear to increase the risk of AEs, particularly perforation, after esophageal dilation using bougie dilators. Caution is needed with the dilation of malignant strictures, as there is an increased risk of perforations and AEs. However, large prospective studies are needed to verify the results of this study., (Copyright © 2017 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: The efficacy and safety of endoscopic gallbladder drainage (EGBD) performed via endoscopic retrograde cholangiography (ERC)-based transpapillary stenting or EUS-based transmural stenting are unknown. We aimed to conduct a proportion meta-analysis to evaluate the cumulative efficacy and safety of these procedures and to compare them with percutaneous gallbladder drainage (PGBD)., Methods: We searched several databases from inception through December 10, 2015 to identify studies (with 10 or more patients) reporting technical success and postprocedure adverse events of EGBD. Weighted pooled rates (WPRs) for technical and clinical success, postprocedure adverse events, and recurrent cholecystitis were calculated for both methods of EGBD. Pooled odds ratios (ORs) were also calculated to compare the technical success and postprocedure adverse events in patients undergoing EGBD versus PGBD., Results: The WPRs with 95% confidence intervals (CIs) of technical success, clinical success, postprocedure adverse events, and recurrent cholecystitis for ERC-based transpapillary drainage were 83% (95% CI, 78%-87%; I 2  = 38%), 93% (95% CI, 89%-96%; I 2  = 39%), 10% (95% CI, 7%-13%; I 2  = 27%), and 3% (95% CI, 1%-5%; I 2  = 0%), respectively. The WPRs for EUS-based drainage for technical success, clinical success, postprocedure adverse events, and recurrent cholecystitis were 93% (95% CI, 87%-96%; I 2  = 0%), 97% (95% CI, 93%-99%; I 2  = 0%), 13% (95% CI, 8%-19%; I 2  = 0%), and 4% (95% CI, 2%-9%; I 2  = 0%), respectively. On proportionate difference, EUS-based drainage had better technical (10%) and clinical success (4%) in comparison with ERC-based drainage. The pooled OR for technical success of EGBD versus PGBD was .51 (95% CI, .09-2.88; I 2  = 23%) and for postprocedure adverse events was .33 (95% CI, .14-.80; I 2  = 16%) in favor of EGBD., Conclusions: EGBD is an efficacious and safe therapeutic modality for treatment of patients with acute cholecystitis who cannot undergo surgery. EGBD shows a similar technical success as PGBD but appears to be safer than PGBD., (Copyright © 2017 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: FNA is the primary method of EUS tissue acquisition. In an attempt to improve our yield of EUS-guided tissue acquisition, we compared fine-needle biopsy (FNB) sampling without rapid onsite evaluation (ROSE) with FNA with ROSE and assessed the concordance of FNA and FNB sampling., Methods: This was a retrospective review of prospectively collected data from consecutive patients. Patients underwent FNB sampling and FNA of the same single lesion, with the same needle gauge and number of passes. FNA with ROSE was performed with a standard FNA needle. FNB sampling was performed with a new dedicated core needle. FNA samples were assessed with ROSE, and a final interpretation was provided by cytopathology staff; FNB samples were analyzed by surgical pathologists, each not made aware of the other's opinion., Results: Thirty-three patients underwent 312 passes in 42 different lesions. A diagnosis of malignancy was more likely with FNB sampling than with FNA (72.7% vs 66.7%, P = .727), although statistical significance was not reached. FNA and FNB sampling had similar sensitivities, specificities, and accuracies for cancer (81.5% vs 88.9%, 100% vs 100%, and 84.8% vs 90.9%, respectively). FNB sampling provided qualitative information not reported on FNA, such as degree of differentiation in malignancy, metastatic origin, and rate of proliferation in neuroendocrine tumors., Conclusions: FNB sampling without ROSE using a dedicated core needle performed as well as FNA with ROSE in this small cohort, suggesting that FNB sampling with this new core needle may eliminate the need for an onsite cytopathologic assessment, without loss of diagnostic accuracy., (Copyright © 2016 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Initial reports suggest that fully covered self-expandable metal stents (FCSEMSs) may be better suited for drainage of dense pancreatic fluid collections (PFCs), such as walled-off pancreatic necrosis. The primary aim was to analyze the effectiveness and safety of FCSEMSs for drainage of different types of PFCs in a large cohort. The secondary aim was to investigate which type of FCSEMS is superior., Methods: This was a retrospective, noncomparative review of a nationwide database involving all hospitals in Spain performing EUS-guided PFC drainage. From April 2008 to August 2013, all patients undergoing PFC drainage with an FCSEMS were included in a database. The main outcome measurements were technical success, short-term (2 weeks) and long-term (6 months) effectiveness, adverse events, and need for surgery., Results: The study included 211 patients (pseudocyst/walled-off pancreatic necrosis, 53%/47%). The FCSEMSs used were straight biliary (66%) or lumen-apposing (34%). Technical success was achieved in 97% of patients (95% confidence interval [CI], 93%-99%). Short-term- and long-term clinical success was obtained in 94% (95% CI, 89%-97%) and 85% (95% CI, 79%-89%) of patients, respectively. Adverse events occurred in 21% of patients (95% CI, 16%-27%): infection (11%), bleeding (7%), and stent migration and/or perforation (3%). By multivariate analysis, patient age (>58 years) and previous failed drainage were the most important factors associated with negative outcome., Conclusions: An FCSEMS is effective and safe for PFC drainage. Older patients with a history of unsuccessful drainage are more likely to fail EUS-guided drainage. The type of FCSEMS does not seem to influence patient outcome., (Copyright © 2016 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Flexible endoscopic septum division (FESD) is a rapidly evolving technique for the treatment of Zenker's diverticulum (ZD). The aim was to perform a systematic review and meta-analysis of the literature focusing on FESD for ZD, including an in-depth evaluation of its efficacy, safety, and limitations., Methods: A comprehensive literature search was completed to identify papers that examined the efficacy and safety of FESD for ZD. Demographic, clinical, and technical information was retrieved. Main outcomes were extracted, pooled, and analyzed. Heterogeneity among studies was assessed using the I(2) statistic. A random effect model was used as the pooling method in cases of high heterogeneity; otherwise the fixed effect model was applied. Meta-regression was also performed. Main outcomes such as rates of success, adverse events, and recurrences were evaluated., Results: Twenty studies with a total of 813 patients were selected. The pooled success, adverse events, and recurrence rates were 91% (95% confidence interval [CI], 86%-95%; I(2) = 69.5%), 11.3% (95% CI, 8%-16%; I(2) = 64%), and 11% (95% CI, 8%-15%; I(2) = 38.4%), respectively. Substantial heterogeneity across studies was found. However, for success rates, excluding 3 studies reduced heterogeneity to non-significant rates [I(2) = 25.6%; P = .154]. Adverse event rates decreased with larger samples (coefficient, -0.0123; 95% CI, -0.03 to -0.003; P = .017), whereas recurrence rates increased (coefficient, 0.006; 95% CI, -0.0010 to 0.0125; P = .093). Year of publication was negatively associated with success rate, whereas the opposite pattern was found for recurrence rates., Conclusions: FESD is a feasible, safe, and effective treatment for symptomatic ZD, with low adverse event and recurrence rates., (Copyright © 2016 American Society for Gastrointestinal Endoscopy. All rights reserved.)