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Pancreatic cancer is the fourth leading cause of cancer mortality for both men and women in the United States. Overall 5-year survival from time of diagnosis is less than 5%. The only meaningful chance for cure results from early detection while the tumor remains resectable without locoregional extension or metastasis. Endoscopic ultrasound (EUS) is uniquely suited to the examination and treatment of the pancreas. Endoscopic ultrasound can provide important information with regard to disease stage including involvement of the mesenteric vasculature, adjacent organ invasion, and regional lymph node metastasis. In addition, EUS is considered the procedure of choice for tissue diagnosis of pancreatic cancer. More recently, EUS has developed therapeutic roles in an array of other clinical situations including EUS-guided fine needle injection, EUS-guided biliary drainage, celiac plexus neurolysis, brachytherapy, fiducial placement, and emerging antitumor agents delivered directly into the tumor. [ABSTRACT FROM AUTHOR]

Background: Endoscopic ultrasound (EUS)-guided gastroenterostomy (EUS-GE) is a minimally invasive therapy for patients with gastric outlet obstruction without the risks of surgical bypass and the limited long-term efficacy of enteral self-expanding metal stent placement. However, due to its novelty, there is a lack of significant data comparing long-term outcomes of patients with EUS-GE, based on the underlying disease. In this study, we compare outcomes of EUS-GE on benign versus malignant indications., Methods: Consecutive patients from 12 international, tertiary care centers who underwent EUS-GE over 3 years were extracted in a retrospective registry. Demographic characteristics, procedure-related information and follow-up data was collected. Primary outcome was the rate of adverse events associated with EUS-GE and the comparison of the rate of adverse events in benign versus malignant diseases. Secondary outcomes included technical and clinical success as well as hospitalization admission., Results: A total of 103 patients were included: 72 malignant and 31 benign. The characteristics of the patients undergoing EUS-GE is shown in Table 1. The mean age of the cohort was 68 years and 58 years for malignant and benign etiology. Gender distribution was 57% and 39% being females in malignant and benign etiology group, respectively. Clinical success, technical success, average procedure time, and hospital length of stay were similar in both groups. Patients with benign underlying etiology had significantly higher number of surgically altered midgut anatomy ( P =0.0379)., Conclusion: EUS-GE is equally efficient regardless of the underlying etiology (malignant vs. benign), and the adverse events both groups were comparable., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Background and study aims Endoscopic ultrasound (EUS)-guided transmural (TM) deployment of lumen-apposing metal stents (LAMS) is considered relatively safe in non-cirrhotic patients and is cautiously offered to cirrhotic patients. Patients and methods This was a retrospective, multicenter, international matched case-control study to study the safety of EUS-guided TM deployment of LAMS in cirrhotic patients. Results Forty-three cirrhotic patients with model for end-stage liver disease score 12.5 ± 5, with 23 having ascites and 16 with varices underwent EUS-guided TM LAMS deployment, including 19 for pancreatic fluid collection (PFC) drainage, 13 gallbladder drainage, six for endoscopic ultrasound-directed transgastric endoscopic retrograde cholangiopancreatography (ERCP), three for EDGI, one for endoscopic ultrasound-directed transenteric ERCP, and one postsurgical collection drainage. Technical failure occurred in one LAMS for PFC drainage. Clinical failure was encountered in another PFC. Nine adverse events (AEs) occurred. The most common AE was LAMS migration (3), followed by non-bleeding mucosal erosion (2), delayed bleeding (2), sepsis (1), and anesthesia-related complication (pulseless electrical activity) (1). Most AEs were graded as mild (6), followed by severe (2), and moderate (1); the majority were managed conservatively. On univariable comparison, risk of AE was higher when using a 20 × 10 mm LAMS and the absence of through-the-LAMS plastic stent(s). Conditional logistic regression of matched case-control patients did not show any association between potential predicting factors and occurrence of AEs. Conclusions Our study demonstrated that mainly in patients with Child-Pugh scores A and B cirrhosis and despite the presence of mild-to-moderate ascites in over half of cases, the majority of AEs were mild and could be managed conservatively. Further studies are warranted to verify the safety of LAMS in cirrhotic patients., Competing Interests: Conflict of Interest T. Zuchelli: Consultant for Boston Scientific, C. Piraka is recipient of study funding from Aries and US Endoscopy. A. Kumar: Consultant for Boston Scientific. T. Kowalski: Consultant for Olympus and Boston Scientific, D. Loren: Consultant for Olympus, A. Schlachterman: consultant for Fujifilm Healthcare and Olympus, M. A. Khashab: Consultant for Boston Scientific, Medtronic, Olympus, Pentax, Apollo, and Laborie; research support from Boston Scientific and royalties from Elsevier and UpToDate. All other authors have no relevant conflicts of interest., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Background and Aims: Mucosal closure adds time but reduces adverse events associated with endoscopic submucosal dissection (ESD). We aimed to assess the closure time (CT), technical success, and cost-effectiveness between a novel through-the-scope helix tack suture system (TTSS) and the over-the-scope suturing system (OTSS)., Methods: In this single-center, prospective, randomized trial, all patients undergoing ESD with anticipated closure were randomized 1:1 to TTSS (study group) or OTSS (control group). Primary outcomes were CT and overall CT (OCT; CT + setup time). Secondary outcomes were rates of technical success, adverse events, and cost-effectiveness., Results: Forty patients were randomized to OTSS (n = 20) or TTSS (n = 20). OTSS and TTSS groups were similar with respect to age, gender, proportion of colorectal polyps, proximal colon polyps, and mean size of the resected specimen (40.9 mm vs 40.4 mm). The mean CT was 18.4 minutes for OTSS and 23.3 minutes for TTSS (P = .36). The mean OCT was 32 minutes for OTSS and 39.5 minutes for TTSS (P = .36). Closure with a primary device was successful in 17 cases (85%) with OTSS and 18 cases (90%) with TTSS (P = .63). No closure-related intraprocedural adverse events or delayed perforations were noted. Mean cost of closure was significantly lower in the TTSS group for lesions <35 mm (P = .008)., Conclusions: TTSS was not found to be superior to OTSS with respect to CT and technical and clinical success for closure of gastric and colorectal ESD defects. TTSS is more cost-effective for closure of lesions <35 mm. (Clinical trial registration number: NCT04925271.)., Competing Interests: Disclosure The following authors disclosed financial relationships: A. Chiang: Chief Medical Officer (GI) at Medtronic. D. E. Loren: Consultant for Boston Scientific, Pinnacle Biologics, and Olympus. T. E. Kowalski: Consultant for Boston Scientific, Ambu USA, and Olympus. A. Schlachterman: Consultant for Fujifilm, Olympus, Apollo Endosurgery, and Lumendi. A. R. Kumar: Consultant for Olympus. All other authors disclosed no financial relationships., (Copyright © 2024 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Introduction: Single-use disposable duodenoscopes (SDD) have been developed to mitigate infectious risks related to reusable duodenoscopes. The aim of this study is to compare the safety and efficacy of the two available SDDs in the United States., Methods: We conducted a comparative study of 2 SDD in consecutive ERCP procedures performed by expert endoscopists from 9 academic centers. Performance ratings, procedure details, and adverse events were collected., Results: A total of 201 patients were included: 129 patients underwent ERCP with Exalt (mean age 63, Males- 66 (51%), 72 with aScope Duodeno (mean age 65, males=30 (42%). A majority of endoscopists had performed >2000 ERCPs in both groups (71% Exalt, 93% aScope Duodeno). Technical success was 92% in both groups (n=119 Exalt-group, n=66 aScope-Duodeno-group). The procedural complexity for the ERCP cases performed were: Grade 1: 35 cases (18%), Grade 2: 83 cases (41%), Grade 3: 65 cases (32%), and Grade 4: 18 cases (9%). Thirteen patients (10%) from the Exalt group and 16 patients (22%) from the aScope Duodeno group required conversion to a reusable duodenoscope. On a scale of 1 to 5, Exalt and aScope Duodeno, respectively, were rated: 2.31 versus 2.60 for location and visualization quality, 1.38 versus 1.57 for maneuverability based on papillary orientation, 1.48 versus 1.15 for suction/air control, and 2.31 versus 2.34 for elevator efficiency. None of the adverse events were related to the SDDs., Conclusions: The 2 SDDs were comparable. Further ongoing enhancements to these devices will improve maneuverability and clinical effectiveness., Competing Interests: A.T.: Consultant for Ninepoint Medical, Endogastric Solutions, Obalon Therapeutics. A.S. has done consulting work for US Endoscopy and Obalon Therapeutics. H.S. has done consulting work for US Endoscopy. M.K. has received grants support from Boston Scientific, Fujinon, W.L. Gore, Apollo Endosurgery, Cook Endoscopy, GI Dynamics, Merit Medical, Interscope Med, Olympus, ERBE, and MI Tech. He is a consultant for Boston Scientific and Laboratories Inc., ABBvie. None of those funding was related to this paper. The remaining authors declare that they have no conflicts of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Background and Aims: EUS-directed transgastric ERCP (EDGE) is an established method for managing pancreaticobiliary pathology in Roux-en-Y gastric bypass patients, with high rates of technical success and low rates of serious adverse events (AEs). However, widespread adoption of the technique has been limited because of concerns about the development of persistent gastrogastric or jejunogastric fistulas. Gastrogastric and jejunogastric fistulas have been reported in up to 20% of cases in some series, but predictive risk factors and long-term management and outcomes are lacking. Therefore, our aims were to assess factors associated with the development of persistent fistulas and the technical success of endoscopic fistula closure., Methods: This is a case-control study involving 9 centers (8 USA, 1 Europe) from February 2015 to September 2021. Cases of persistent fistulas were defined as endoscopic or imaging evidence of fistula more than 8 weeks after lumen-apposing metal stent (LAMS) removal. Control subjects were defined as endoscopic or imaging confirmation of no fistula more than 8 weeks after LAMS removal. AEs were defined and graded according to the American Society for Gastrointestinal Endoscopy lexicon., Results: Twenty-five patients identified to have evidence of a persistent fistula on follow-up surveillance (cases) were matched with 50 patients with no evidence of a persistent fistula on follow-up surveillance (control subjects) based on age and sex. Mean LAMS dwell time was 74.7 ± 106.2 days. After LAMS removal, argon plasma coagulation (APC) ablation of the fistula was performed in 46 patients (61.3%). Primary closure of the fistula was performed in 26.7% of patients (20: endoscopic suturing in 17, endoscopic tacking in 2, and over-the-scope clips + endoscopic suturing in 1). When comparing cases with control subjects, there was no difference in baseline demographics, fistula site, LAMS size, or primary closure frequency between the 2 groups (P > .05). However, in the persistent fistula group, the mean LAMS dwell time was significantly longer (127 vs 48 days, P = .02) and more patients had ≥5% total body weight gain (33.3% vs 10.3%, P = .03). LAMS dwell time was a significant predictor of persistent fistula (odds ratio, 4.5 after >40 days in situ, P = .01). The odds of developing a persistent fistula increased by 9.5% for every 7 days the LAMS was left in situ. In patients with a persistent fistula, endoscopic closure was attempted in 19 (76%) with successful resolution in 14 (73.7%)., Conclusions: Longer LAMS dwell time was found to be associated with a higher risk of persistent fistulas in EDGE patients. APC or primary closure of the fistula on LAMS removal was not found to be protective against developing a persistent fistula, which, if present, can be effectively managed through endoscopic closure in most cases., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Placement of a lumen-apposing metal stent (LAMS) between the gastric pouch and the excluded stomach allows for EUS-guided transgastric interventions (EDGIs) in patients with Roux-en-Y gastric bypass (RYGB). Although EUS-guided transgastric ERCP (EDGE) outcomes have been reported, data are scant on other endoscopic interventions. We aimed to evaluate the outcomes and safety of EDGIs., Methods: This retrospective study involved 9 centers (United States, 8; Europe, 1) and included patients with RYGB who underwent EDGIs between June 2015 and September 2021. The primary outcome was the technical success of EDGIs. Secondary outcomes were adverse events (AEs), length of hospital stay, and fistula follow-up and management., Results: Fifty-four EDGI procedures were performed in 47 patients (mean age, 61 years; 72% women), most commonly for the evaluation of a pancreatic mass (n = 16) and management of pancreatic fluid collections (n = 10). A 20-mm LAMS was used in 26 patients and a 15-mm LAMS in 21, creating a gastrogastrostomy in 37 patients and jejunogastrostomy in 10. Most patients (n = 30, 64%) underwent a dual-session EDGI, with a median interval of 17 days between the 2 procedures. Single-session EDGI was performed in 17 patients, of whom 10 (59%) had anchoring of the LAMS. The most common interventions were diagnostic EUS (with or without FNA or fine-needle biopsy sampling; n = 28) and EUS-guided cystgastrostomy (n = 8). The mean procedural time was 97.6 ± 78.9 minutes. Technical success was achieved in 52 patients (96%). AEs occurred in 5 patients (10.6%), of which only 1 AE (2.1%) was graded as severe. Intraprocedural LAMS migration was the most common AE, occurring in 3 patients (6.4%), whereas delayed spontaneous LAMS migration occurred in 2 (4.3%). Four of the 5 LAMS migration events were managed endoscopically, and 1 required surgical repair. LAMS anchoring was found to be protective against LAMS migration (P = .001). The median duration of hospital stay was 2.1 ± 3.7 days. Of the 17 patients who underwent objective fistula assessment endoscopically or radiologically after LAMS removal, 2 (11.7%) were found to have persistent fistulas. In 1 case the fistula was intentionally left open to assist with weight gain. The other fistula was successfully closed endoscopically., Conclusions: EDGI is effective and safe for the diagnosis and management of pancreaticobiliary and foregut disorders in RYGB patients. It is associated with high rates of technical success and low rates of severe AEs. LAMS migration is the most common AE with evidence that anchoring can be protective against its occurrence. Persistent fistulas may occur, but endoscopic closure seems to be effective., (Copyright © 2022 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background: Most studies on endoscopic ultrasound (EUS)-guided gastroenterostomy (EUS-GE) for palliation of malignant gastric outlet obstruction (GOO) utilized a 15-mm lumen-apposing metal stent (LAMS). More recently, a 20-mm LAMS has become available. This study aimed to compare rates of technical and clinical success and adverse events (AEs) in patients undergoing EUS-GE using a 20-mm vs. 15-mm LAMS., Methods: Patients who underwent EUS-GE with 15-mm or 20-mm LAMS for malignant GOO during the period from January 2018 to October 2020 were included. The primary outcome was clinical success, defined as an increase in the gastric outlet obstruction score (GOOS) by at least 1 point during follow-up. Secondary outcomes were technical success, maximum tolerated diet, re-intervention rate, and rate/severity of AEs., Results: 267 patients (mean age 67 years, 43 % women) with malignant GOO from 19 centers underwent EUS-GE. Clinical success rates were similar for the 15-mm and 20-mm stents (89.2 % [95 %CI 84.2 %-94.2 %] vs. 84.1 % [77.4%-90.6 %], respectively). However, a significantly higher proportion of patients in the 20-mm group tolerated a soft solid/complete diet at the end of follow-up (91.2 % [84.4 %-95.7 %] vs. 81.2 % [73.9 %-87.2 %], P  = 0.04). Overall, AEs occurred in 33 patients (12.4 % [8.4 %-16.3 %]), with similar rates for 15-mm and 20-mm stents (12.8 % [7.5 %-18.2 %] vs. 11.8 % [6 %-17.6 %]), including incidence of severe/fatal AEs (2 % [0.4 %-5.8 %] vs. 3.4 % [0.9 %-8.4 %])., Conclusions: The 20-mm and 15-mm LAMS show similar safety and efficacy for patients undergoing EUS-GE for malignant GOO. The 20-mm LAMS allows a more advanced diet and is, thus preferred for EUS-GE., Competing Interests: A. Anderloni is a consultant for Boston Scientific, Medtronic and Olympus. J.R. Aparicio is a consultant for Boston Scientific. J.M. Buscaglia is a consultant for Abbvie. B. Confer is a consultant for Boston Scientific. D.L. Diehl is a consultant for Boston Scientific. C.J. DiMaio is a consultant for Boston Scientific, Covidien, and SafeHeal; and a speaker for AbbVie, Mauna Kea, and STERIS. A. Fugazza is a consultant for Boston Scientific and Olympus. M.T. Huggett is a consultant for Boston Scientific, Olympus America, and Cook Medical. M.A. Khashab is a consultant for Boston Scientific, Olympus, Medtronic, GI Supply, MicroTech, and Apollo. H.S. Khara is a consultant for Boston Scientific. T.E. Kowalski is a consultant for Boston Scientific and Medtronic. N.A. Kumta is a consultant for Boston Scientific, Apollo Endosurgery, Intuitive Surgery, Medtronic, and Olympus. D. Loren is a consultant for Boston Scientific, Olympus, and Pinnacle Biologics; and receives research support from Medtronic. J.M. Nieto is a consultant for Boston Scientific. B. Paranandi is a consultant for Boston Scientific and Olympus America. K. D-C. Pham is a consultant for Boston Scientific; he is a speaker for Boston Scientific, Cook Medical, Olympus America and Taewoong Medical; and he is on on the advisory board of Ambu. D.K. Pleskow is a consultant for Boston Scientific, Olympus America, and FujiFilm. D.V. Sejpal is a consultant for Boston Scientific and Olympus America. R.Z. Sharaiha is a consultant for Boston Scientific, Cook Medical, Olympus, and Lumendi. A.J. Trindade is a consultant for Pentax Medical and Olympus America. R.R. Watson is a consultant for Boston Scientific. The remaining authors declare that they have no conflict of interest., (Thieme. All rights reserved.)

Competing Interests: Disclosure The authors report no conflicts of interest in this work.

Background and Aims: The American Society for Gastrointestinal Endoscopy (ASGE) advanced endoscopy fellowship (AEF) match offers a structured application process for AEF training in the United States. Our aim was to describe recent trends in AEF match, trainee experience, and postfellowship employment., Methods: ASGE AEF match data from 2012 to 2020 were reviewed. Online surveys were sent to advanced endoscopy trainees in 2019 and 2020 to explore their perceptions about AEF training and postfellowship jobs., Results: Data for 2020 showed 19% of matched applicants were women, 55% foreign medical graduates, and 17.5% U.S. visa holders. The number of AEF match applicants increased by 15.6% (90 in 2012 to 104 in 2020) and number of AEF programs increased by 23.5% (51 in 2012 to 63 in 2020). The average applicant match rate was 57% (range, 52.8%-60.6%) and position match rate 87.9% (range, 79.1%-94.6%). Ninety-one percent of trainees (n = 58) rated the quality of their training as very good/excellent; 75% of trainees participated in >300 ERCPs and 64.1% in >300 EUS cases. Seventy percent of trainees reported that advanced endoscopic procedures comprised ≤50% of their procedure volume in their first job, and 71.9% believed it was not easy to find a job after fellowship; however, 97% believed they would make the same decision to pursue AEF training again., Conclusions: There has been a steady increase in the number of advanced endoscopy applicants and training positions over recent years. Most graduating fellows reported 50% or less of their upcoming clinical practice would involve advanced endoscopic procedures. Future studies are needed to further clarify employment opportunities and personnel needs for advanced endoscopists., (Copyright © 2021 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background: Endoscopic ultrasound-directed transgastric endoscopic retrograde cholangiopancreatography (ERCP; EDGE) is an alternative to enteroscopy- and laparoscopy-assisted ERCP in patients with Roux-en-Y gastric bypass anatomy. Although short-term results are promising, the long-term outcomes are not known. The aims of this study were: (1) to determine the rates of long-term adverse events after EDGE, with a focus on rates of persistent gastrogastric or jejunogastric fistula; (2) to identify predictors of persistent fistula; (3) to assess the outcomes of endoscopic closure when persistent fistula is encountered., Methods: This was a multicenter retrospective study involving 13 centers between February 2015 and March 2019. Adverse events were defined according to the ASGE lexicon. Persistent fistula was defined as an upper gastrointestinal series or esophagogastroduodenoscopy showing evidence of fistula., Results: 178 patients (mean age 58 years, 79 % women) underwent EDGE. Technical success was achieved in 98 % of cases (175/178), with a mean procedure time of 92 minutes. Periprocedural adverse events occurred in 28 patients (15.7 %; mild 10.1 %, moderate 3.4 %, severe 2.2 %). The four severe adverse events were managed laparoscopically. Persistent fistula was diagnosed in 10 % of those sent for objective testing (9/90). Following identification of a fistula, 5 /9 patients underwent endoscopic closure procedures, which were successful in all cases., Conclusions: The EDGE procedure is associated with high clinical success rates and an acceptable risk profile. Persistent fistulas after lumen-apposing stent removal are uncommon, but objective testing is recommended to identify their presence. When persistent fistulas are identified, endoscopic treatment is warranted, and should be successful in closing the fistula., Competing Interests: A.L. Chang has received consultancy fees and research support from Boston Scientific; T.E. Kowalski has received consultancy fees from Boston Scientific and Medtronic; T.H. Baron has received consultancy fees from Boston Scientific, Cook Endoscopy, W.L. Gore, Medtronic, and Olympus America, and speaker’s fees from Medtronic; J. Nieto has received consultancy fees from Boston Scientific and Olympus America, and speaker’s fees from AbbVie; J.Y. Nasr has received consultancy fees from Boston Scientific; H.S. Khara has received consultancy fees from Boston Scientific and speaker’s fees from Olympus America, Covidien, Gyrus ACMI, Inc., and US Endoscopy; S. Irani has received research support from Boston Scientific; R.J. Law has received consultancy fees from Boston Scientific, Olympus America, and ERBE, and research support from Cook Medical; D.E. Loren has received consultancy fees from Boston Scientific and Olympus America; D.L. Diehl has received consultancy fees from Boston Scientific, Cook Endoscopy, Olympus America, Pentax Medical, Lumendi, US Endoscopy, and C2 Therapeutics, and speaker’s fees from Boston Scientific and Olympus America; M.A. Al-Haddad has received consultancy fees and research support from Boston Scientific; D.K. Pleskow has received consultancy fees from Boston Scientific, Olympus, Fuji, Nine Point Medical, and Medtronic; M. Huggett has received consultancy fees from Boston Scientific and Cook Endoscopy, and speaker’s fees from Boston Scientific, Cook Endoscopy, and Olympus; A.J. Trindade has received consultancy fees from Olympus America, C2 Therapeutics, and Pentax Medical; V. Kumbhari has received consultancy fees from Apollo Endosurgery, Boston Scientific, Medtronic, Pentax Medical, and ReShape Lifescience, and research support from ERBE, C2 Therapeutics, and Ovesco; M.A. Khashab has received consultancy fees from and is on the advisory board of Boston Scientific and Olympus America, and has received consultancy fees from Medtronic. The remaining authors declare that they have no conflict of interest., (Thieme. All rights reserved.)

Background: Introduction of the full-thickness resection device (FTRD) has allowed endoscopic resection of difficult lesions such as those with deep wall origin/infiltration or those located in difficult anatomic locations. The aim of this study is to assess the outcomes of the FTRD among its early users in the USA., Methods: Patients who underwent endoscopic full-thickness resection (EFTR) for lower gastrointestinal tract lesions using the FTRD at 26 US tertiary care centers between 10/2017 and 12/2018 were included. Primary outcome was R0 resection rate. Secondary outcomes included rate of technical success (en bloc resection), achievement of histologic full-thickness resection (FTR), and adverse events (AE)., Results: A total of 95 patients (mean age 65.5 ± 12.6 year, 38.9% F) were included. The most common indication, for use of FTRD, was resection of difficult adenomas (non-lifting, recurrent, residual, or involving appendiceal orifice/diverticular opening) (66.3%), followed by adenocarcinomas (22.1%), and subepithelial tumors (SET) (11.6%). Lesions were located in the proximal colon (61.1%), distal colon (18.9%), or rectum (20%). Mean lesion diameter was 15.5 ± 6.4 mm and 61.1% had a prior resection attempt. The mean total procedure time was 59.7 ± 31.8 min. R0 resection was achieved in 82.7% while technical success was achieved in 84.2%. Histologically FTR was demonstrated in 88.1% of patients. There were five clinical AE (5.3%) with 2 (2.1%) requiring surgical intervention., Conclusions: Results from this first US multicenter study suggest that EFTR with the FTRD is a technically feasible, safe, and effective technique for resecting difficult colonic lesions.

Background: To compare fully covered bi-flanged metal stents (BFMS) and lumen-apposing metal stents (LAMS) for endoscopic ultrasound (EUS)-guided drainage/debridement of pancreatic walled-off necrosis (WON)., Methods: Patients with WON managed by EUS-guided therapy were divided into those who underwent: 1) drainage using BFMS; and 2) drainage using LAMS and scheduled direct endoscopic necrosectomy (DEN). Clinical success (resolution of the WON), technical success (successful stent placement), and adverse events (AEs) were evaluated., Results: 387 patients underwent WON endoscopic drainage, 205 using BFMS and 182 using LAMS. The clinical success in the BFMS or LAMS groups were similar (197 [96.1%] vs. 174 [95.6%]; P=0.81). Median number of procedures required for WON resolution was significantly lower in BFMS compared to LAMS (2 vs. 3, P<0.001). Technical success for stent placement was similar in BFMS and LAMS groups (203 [99%] vs. 180 [99%], P=0.90). Procedure-related AEs were similar in the BFMS and LAMS groups (19 [9.3%] vs. 20 [10.9%], P=0.61). Stent dysfunction with occluding debris was higher in the BFMS group compared to LAMS group (21 [10.2 %] vs. 11 [5.9%], P=0.04). The migration rate was higher in the BFMS group than in the LAMS group (15 [7.3%] vs. 3 [1.6%]; P<0.001). DEN was required in 23 [11.2%] patients in the BFMS group after lack of WON resolution by conservative means., Conclusion: BFMS with a "step-up approach" and LAMS with scheduled DEN are both safe and effective for EUS-guided drainage/debridement of WON., Competing Interests: Conflict of Interest: None, (Copyright: © 2021 Hellenic Society of Gastroenterology.)

Background and study aims  The Full-Thickness Resection Device (FTRD) provides a novel treatment option for lesions not amenable to conventional endoscopic resection techniques. There are limited data on the efficacy and safety of FTRD for resection of upper gastrointestinal tract (GIT) lesions. Patients and methods  This was an international multicenter retrospective study, including patients who had an endoscopic resection of an upper GIT lesion using the FTRD between January 2017 and February 2019. Results  Fifty-six patients from 13 centers were included. The most common lesions were mesenchymal neoplasms (n = 23, 41 %), adenomas (n = 7, 13 %), and hamartomas (n = 6, 11 %). Eighty-four percent of lesions were located in the stomach, and 14 % in the duodenum. The average size of lesions was 14 mm (range 3 to 33 mm). Deployment of the FTRD was technically successful in 93 % of patients (n = 52) leading to complete and partial resection in 43 (77 %) and 9 (16 %) patients, respectively. Overall, the FTRD led to negative histological margins (R0 resection) in 38 (68 %) of patients. A total of 12 (21 %) mild or moderate adverse events (AEs) were reported. Follow-up endoscopy was performed in 31 patients (55 %), on average 88 days after the procedure (IQR 68-138 days). Of these, 30 patients (97 %) did not have any residual or recurrent lesion on endoscopic examination and biopsy, with residual adenoma in one patient (3 %). Conclusions  Our results suggest a high technical success rate and an acceptable histologically complete resection rate, with a low risk of AEs and early recurrence for FTRD resection of upper GIT lesions., Competing Interests: Competing interests Dr. Khashab is a consultant for Boston Scientific, Medtronic and Olympus. Dr. Grimm is a consultant for Boston Scientific. Dr. Irani is a consultant for Boston Scientific. Dr. Kumbhari is a consultant for ReShape Life Sciences, Apollo Endosurgery, Medtronic, and Boston Scientific. Dr. Nikhil is a consultant for Apollo Endosurgery, Boston scientific, and Olympus. Dr. Amateau is a consultant for Merit Endoscopy, Boston Scientific, US Endoscopy, and Neurotronic and the recipient of research support from Cook Medical. Dr. Smallfield has research funding from CSA Medical and C2 Therapeutics. Dr. Aadam is a consultant for Boston Scientific. Dr. Diehl is a consultant for Boston Scientific, Olympus, Pentax, and Cook Medical. Dr. Chang is a consultant for Apollo, Boston Scientific, Cook, Covidien, Erbe, Endogastric Solutions, Mauna Kea Technologies, Mederi, Medtronic, Olympus, Ovesco, Pentax, and Torax. Dr. Samarasena has an educational grant from Cook and is a consultant for Mauna Kea Technologies, Medtronic, Olympus, Pentax, and US Endoscopy. Dr. Al-Haddad received research and teaching support from Boston Scientific. Dr. Friedland is a consultant for Boston Scientific and CapsoVision. Dr. Templeton is a consultant for Boston Scientific and Medtronic. Dr. Ginsberg is a consultant for Olympus and Boston Scientific. Dr. Fukami is a consultant for Boston Scientific and Olympus. Dr. Mahadev is a consultant for Olympus and Conmed. Dr Sharaiha is a consultant for Olympus, Boston Scientific, and Cook. Dr Carr-Locke is a consultant for Boston Scientific Endoscopy and receives royalties from Steris Corporation and Telemed Systems. Dr. Schmidt has received lecture fees and research funding from Ovesco Endoscopy., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commecial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Backgrounds: Endoscopic ultrasound (EUS)-guided placement of lumen-apposing metal stents (LAMSs) has gained popularity for the treatment of pancreatic walled-off necrosis (WON). We compared the 20-mm and 15-mm LAMSs for the treatment of symptomatic WON in terms of clinical success and adverse events., Methods: We conducted a retrospective, case-matched study of 306 adults at 22 tertiary centers from 04/2014 to 10/2018. A total of 102 patients with symptomatic WON who underwent drainage with 20-mm LAMS (cases) and 204 patients who underwent drainage with 15-mm LAMS (controls) were matched by age, sex, and drainage approach. Conditional logistic regression analysis was performed to compare clinical success (resolution of WON on follow-up imaging without reintervention) and adverse events (according to American Society for Gastrointestinal Endoscopy criteria)., Results: Clinical success was achieved in 92.2 % of patients with 20-mm LAMS and 91.7 % of patients with 15-mm LAMS (odds ratio 0.92; P  = 0.91). Patients with 20-mm LAMS underwent fewer direct endoscopic necrosectomy (DEN) sessions (mean 1.3 vs. 2.1; P  < 0.001), despite having larger WON collections (transverse axis 118.2 vs. 101.9 mm, P  = 0.003; anteroposterior axis 95.9 vs. 80.1 mm, P  = 0.01). There was no difference in overall adverse events (21.6 % vs. 15.2 %; P  = 0.72) and bleeding events (4.9 % vs. 3.4 %; P  = 0.54) between the 20-mm and 15-mm LAMS groups, respectively., Conclusions: The 20-mm LAMS showed comparable clinical success and safety profile to the 15-mm LAMS, with the need for fewer DEN sessions for WON resolution., Competing Interests: Drs. Arlt, Ellrichmann, Aparicio, Sejpal, Irani, Pawa, Ahmed, Sedarat, Hampe, Sharaiha, Berzin, Stevens, Willingham, Kushnir, Ngamruengphong, Hugget, Baron, Repici, Adler, Nasr, Kowalski, Kumbhari, and Khashab are consultants for Boston Scientific. Dr. Trindade is a consultant for Pentax Medical and CSA Medical. Dr. Benias is a consultant for Fujifilm, Medtronic, and Apollo. Dr. Sejpal is also a consultant for Olympus America. Dr. Ahmed is also a consultant for Cook Medical. Dr. Hampe is also a consultant for Cook Medical, Olympus America, and B. Braun. Dr. Sharaiha is also a consultant for Olympus America and Apollo. Dr. Chahal is a consultant for Medtronic. Dr. Willingham is also a consultant for RedPath, Cook Medical, Xlumena, Oncolys Biopharma, and has received research funding to the university from Cancer Prevention Pharmaceuticals. Dr. Hugget is also a consultant for Cook Medical. Dr. Repici has also received research funding from Boston Scientific. Dr. Kumbhari is also a consultant for Medtronic, Reshape Lifesciences, and Apollo Endosurgery, and has received research support from ERBE and Apollo Endosurgery. Dr. Singh is a consultant for Abbvie and Novo Nordisk, and is a member of an advisory board for Akcea. Dr. Khashab is also a consultant for Olympus America and Medtronic. All other authors have no conflict of interest to disclose., (© Georg Thieme Verlag KG Stuttgart · New York.)

Introduction: Lumen apposing metal stents (LAMS) have been used increasingly for drainage of pancreatic fluid collections (PFC). We present an international, multicenter study evaluating the safety and efficacy of LAMS in PFCs., Methods: Consecutive patients undergoing LAMS placement for PFC at 12 international centers were included (ClinicalTrials.gov NCT01522573). Demographics, clinical history, and procedural details were recorded. Technical success was defined as successful LAMS deployment. Clinical success was defined as PFC resolution at three-month follow-up., Results: 192 patients were included (140 males (72.9%), mean-age 53.8 years), with mean follow-up of 4.2 months ± 3.8. Mean PFC size was 11.9 cm (range 2-25). The median number of endoscopic interventions was 2 (range 1-14). Etiologies for PFC were gallstone (n = 82, 42.7%), alcohol (n = 50, 26%), idiopathic (n = 26, 13.5%), and other (n = 34, 17.7%). Technical success was achieved in 189 patients (98.4%). Clinical success was observed in 125 of 135 patients (92.6%). Adverse events included bleeding (n = 11, 5.7), infection (n = 2, 1%), and perforation (n = 2, 1%). Three or more endoscopy sessions were a positive predictor for PFC resolution and the only significant predictor for AEs., Conclusion: LAMS has a high technical and clinical success rate with a low rate of AEs. PFC drainage via LAMS provides a minimally invasive, safe, and efficacious procedure for PFC resolution., (Copyright © 2019 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background and Objectives: Endoscopic drainage/debridement of symptomatic walled off necrosis (WON) using lumen-apposing metal stents (LAMS) is both safe and effective. While endoscopic management of WON is the standard approach to treatment, the ideal concomitant medical therapy remains unclear. The purpose of this study was to further elucidate the effect of proton pump inhibitor (PPIs) therapy on the technical and clinical success of endoscopic treatment of WON., Methods: Two hundred and seventy-two patients in 8 centers with WON managed by endoscopic drainage using LAMS were evaluated. Patients were followed for at least 6 months following treatment. The patients were divided into two groups: Those that used PPIs continuously during the therapy and those not on PPIs continuously during the interval of therapy. Outcomes included but were not limited to technical success, clinical success, number of procedures performed, and adverse events., Results: From 2013 to 2016, 272 patients underwent WON drainage with successful transmural LAMS placement. The two groups were split evenly into PPI users and non-PPI users, and matched in regards to demographics, etiology of pancreatitis, WON size, and location. There was no difference in the technical success between the two groups (100% vs. 98.8%, P = 1), or in clinical success rates (78.7% vs. 77.9%). There was a significant difference in the required number of direct endoscopic necrosectomies to achieve clinical success in the PPI vs. non-PPI group (3.2 vs. 4.6 respectively, P < 0.01). There were significantly more cases of stent occlusion in the non-PPI group vs. PPI group (9.5% vs. 20.1% P = 0.012), but all other documented adverse events were not significantly different., Conclusion: Discontinuing PPIs during endoscopic drainage and necrosectomy of symptomatic WON appears to reduce the number of endoscopic procedures required to achieve resolution. Continuous PPI results in higher rates of early stent occlusion., Competing Interests: None

Background: Percutaneous cholecystostomy tube (PTGBD), endoscopic retrograde cholangiopancreatography with transpapillary gallbladder drainage (TP), and endoscopic ultrasound-guided transmural gallbladder drainage (EGBD) using lumen-apposing metal stents (LAMS) have been offered for gallbladder decompression for acute cholecystitis in high-risk surgical patients. Yet, there are limited data comparing these therapies. Our aim was to compare the safety and efficacy of EGBD to TP and PTGBD for gallbladder drainage., Methods: We retrospectively collected high-risk surgical patients from six centers with acute cholecystitis who underwent gallbladder drainage by EGBD, TP, or PTGBD. Data included technical success (gallbladder drainage), clinical success (acute cholecystitis resolution), adverse events (AE), and follow-up., Results: From 2010 to 2016, 372 patients underwent gallbladder drainage, with 146 by PTGBD, 124 by TP, and 102 drained by EGBD. Technical (98% vs. 88% vs. 94%; p = 0.004) and Clinical (97% vs. 90% vs. 80%; p < 0.001) success rates were significantly higher with PTGBD and EGBD compared to TP. PTGBD group had statistically significantly higher number of complications as compared to EGBD and TP groups (2 0% vs. 2% vs. 5%; p = 0.01). Mean hospital stay in the EGBD group was significantly less than TP and PTGBD (16 vs. 18 vs. 19 days; p = 0.01), while additional surgical intervention was significantly higher in the PTGBD group compared to the EGBD and TP groups (49% vs. 4% vs. 11%; p < 0.0001)., Conclusions: EGBD with LAMS is an effective and safer alternative to TP and PTGBD for treatment of patients with acute cholecystitis who cannot undergo surgery. EGBD with LAMS has significantly lower overall AEs, hospital stay, and unplanned admissions compared to PTGBD., Trial Registration: ClinicalTrials.gov Identifier: NCT01522573.

Indeterminate biliary strictures pose a diagnostic and therapeutic challenge. Although underlying malignancy is a primary concern, biliary strictures may result from benign processes. An accurate diagnosis is paramount to define the treatment strategy and minimize morbidity. The limitations of traditional endoscopic retrograde cholangiopancreatography-based tissue acquisition with cytology brushings are well-documented. Endoscopic retrograde cholangiopancreatography is generally unable to determine a stricture's etiology. Complementary advanced endoscopic imaging and multimodal tissue acquisition have evolved. Careful consideration of the clinical presentation, location of the stricture, and interpretation of imaging constitute the most optimal approach for diagnosis and management., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Fully-covered self-expandable metal stents (FCSEMS) have been used in benign biliary diseases although reported data is limited. These devices are most commonly used to treat biliary leaks, strictures, or both. The aim of this study was to evaluate effectiveness of FCSEMS in treating benign biliary disease and recognize the associated complications., Methods: We performed a multicenter longitudinal retrospective cohort study of patients with benign biliary disease needing FCSEMS between 2011 and 2016. Descriptive statistics were performed using SPSS version 24 (SPSS Inc, Chicago, IL, USA) and continuous variables were presented as mean±standard deviation., Results: 75, 57% M/43% F, with a mean age of 58.5±14.9 years, were included. 64 (85%) had benign strictures, 7 patients had leaks, and 4 patients had both a leak and a stricture. Chronic pancreatitis was the most common cause of BBS (47%) and cholecystectomy was the most common cause of leaks. FCSEMS placement was technically successful in all patients. Four patients died of unrelated causes. A recurrent stricture was observed in 24 (32%) of the patients. Recurrent strictures were most commonly seen in patients with chronic pancreatitis 12/35 (34%). Stent migration occurred in 8/75 patients (10.7%). Seven patients (9.3%) had adverse events, acute pancreatitis (N.=4) was most common., Conclusions: FCSEMS are safe and effective for treating biliary strictures and leaks. We report decreased rates of stent migration compared to previous studies. Prospective studies are needed to compare plastic stents with FCSEMS, determine optimal stent in-dwell times and cost effectiveness of FCSEMS.

Background and Aims: The obesity epidemic has led to increased use of Roux-en-Y gastric bypass (RYGB). These patients have an increased incidence of pancreaticobiliary diseases, yet standard ERCP is not possible because of surgically altered gastroduodenal anatomy. Laparoscopy-assisted ERCP (LA-ERCP) has been proposed as an option, but supporting data are derived from single-center small case series. Therefore, we conducted a large multicenter study to evaluate the feasibility, safety, and outcomes of LA-ERCP., Methods: This is a retrospective cohort study of adult patients with RYGB who underwent LA-ERCP in 34 centers. Data on demographics, indications, procedure success, and adverse events were collected. Procedure success was defined when all the following were achieved: reaching the papilla, cannulating the desired duct, and providing endoscopic therapy as clinically indicated., Results: A total of 579 patients (median age, 51; 84% women) were included. Indication for LA-ERCP was biliary in 89%, pancreatic in 8%, and both in 3%. Procedure success was achieved in 98%. Median total procedure time was 152 minutes (interquartile range [IQR], 109-210), with a median ERCP time of 40 minutes (IQR, 28-56). Median hospital stay was 2 days (IQR, 1-3). Adverse events were 18% (laparoscopy related, 10%; ERCP related, 7%; both, 1%) with the clear majority (92%) classified as mild/moderate, whereas 8% were severe and 1 death occurred., Conclusions: Our large multicenter study indicates that LA-ERCP in patients with RYGB is feasible with a high procedure success rate comparable with that of standard ERCP in patients with normal anatomy. The ERCP-related adverse events rate is comparable with conventional ERCP, but the overall adverse event rate was higher because of the added laparoscopy-related events., (Copyright © 2018 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Objectives: To use subharmonic imaging (SHI) to depict the vascularity of pancreatic masses compared to contrast-enhanced endoscopic ultrasound (EUS) and pathologic results., Methods: Sixteen patients scheduled for biopsy of a pancreatic mass were enrolled in an Institutional Review Board-approved study. Pulse-inversion SHI (transmitting/receiving at 2.5/1.25 MHz) was performed on a LOGIQ 9 system (GE Healthcare, Milwaukee, WI) with a 4C transducer, whereas contrast harmonic EUS (transmitting/receiving at 4.7/9.4 MHz) was performed with a radial endoscope (GF-UTC180; Olympus Corporation, Tokyo, Japan) connected to a ProSound SSD α-10 scanner (Hitachi Aloka, Tokyo, Japan). Two injections of the contrast agent Definity (Lantheus Medical Imaging, North Billerica, MA) were administrated (0.3-0.4 and 0.6-0.8 mL for EUS and SHI, respectively). Contrast-to-tissue ratios (CTRs) in the mass and an adjacent vessel were calculated. Four physicians independently scored the images (benign to malignant) for diagnostic accuracy and inter-reader agreement., Results: One patient dropped out before imaging, leaving 11 adenocarcinomas, 1 gastrointestinal stromal tumor with pancreatic infiltration, and 3 benign masses. Marked subharmonic signals were obtained in all patients, with intratumoral blood flow clearly visualized with SHI. Significantly greater CTRs were obtained in the masses with SHI than with EUS (mean ± SD, 1.71 ± 1.63 versus 0.63 ± 0.89; P = .016). There were no differences in the CTR in the surrounding vessels or when grouped by pathologic results (P > .60). The accuracies for contrast EUS and SHI were low (<53%), albeit with a greater κ value for SHI (0.34) than for EUS (0.13)., Conclusions: Diagnostic accuracy of contrast EUS and transabdominal SHI for assessment of pancreatic masses was quite low in this pilot study. However, SHI had improved tumoral CTRs relative to contrast EUS., (© 2017 by the American Institute of Ultrasound in Medicine.)

Background and Objectives: The ability to obtain adequate tissue of solid pancreatic lesions by EUS-guided remains a challenge. The aim of this study was to compare the performance characteristics and safety of EUS-FNA for evaluating solid pancreatic lesions using the standard 22-gauge needle versus a novel EUS biopsy needle., Methods: This was a multicenter retrospective study of EUS-guided sampling of solid pancreatic lesions between 2009 and 2015. Patients underwent EUS-guided sampling with a 22-gauge SharkCore (SC) needle or a standard 22-gauge FNA needle. Technical success, performance characteristics of EUS-FNA, the number of needle passes required to obtain a diagnosis, diagnostic accuracy, and complications were compared., Results: A total of 1088 patients (mean age = 66 years; 49% female) with pancreatic masses underwent EUS-guided sampling with a 22-gauge SC needle (n = 115) or a standard 22-gauge FNA needle (n = 973). Technical success was 100%. The frequency of obtaining an adequate cytology by EUS-FNA was similar when using the SC and the standard needle (94.1% vs. 92.7%, respectively). The sensitivity, specificity, and diagnostic accuracy of EUS-FNA for tissue diagnosis were not significantly different between two needles. Adequate sample collection leading to a definite diagnosis was achieved by the 1 st , 2 nd , and 3 rd pass in 73%, 92%, and 98% of procedures using the SC needle and 20%, 37%, and 94% procedures using the standard needle (P < 0.001), respectively. The median number of passes to obtain a tissue diagnosis using the SC needle was significantly less as compared to the standard needle (1 and 3, respectively; P< 0.001)., Conclusions: The EUS SC biopsy needle is safe and technically feasible for EUS-FNA of solid pancreatic mass lesions. Preliminary results suggest that the SC needle has a diagnostic yield similar to the standard EUS needle and significantly reduces the number of needle passes required to obtain a tissue diagnosis., Competing Interests: There are no conflicts of interest.

Background and Aims: The optimal method for endoscopic placement of bilateral self-expanding metal stents (SEMS) for the management of malignant hilar biliary obstruction has not been determined. The aim of this study was to compare the efficacies and complication rates between SEMS placed above and across the sphincter of Oddi (SO) in patients with malignant hilar biliary obstruction., Materials and Methods: A retrospective review of patients with malignant hilar strictures who underwent bilateral SEMS placement at 3 centers was performed. Patients were divided into 2 groups: group A (above SO, n=52) or B (across SO, n=120). Patient demographics, technical success (successful SEMS placement across the stricture), functional success (decrease in pretreatment bilirubin level), complications, stent occlusion, and patient survival in the 2 groups were evaluated., Results: We identified 172 patients with malignant hilar biliary obstruction (106 males, mean age 67 y). Significantly more early complications (1.9% vs. 11.7%, P=0.04) were seen in group B, mainly post-endoscopic retrograde cholangio-pancreatography pancreatitis. Mean SEMS patency periods were 33 weeks for group A and 29.6 weeks for group B (P=0.3). Occlusion rates were 50% and 45% for groups A and B (P=0.61); occlusion was due to tumor in-growth or overgrowth in all patients. SEMS occlusion was successfully treated endoscopically in 85% (22/26) patients in group A and 96% (52/54) in group B (P=0.24). The median survival time was 26 weeks in the group A and 29 weeks in group B (P=0.49)., Discussion: Bilateral side-by-side SEMS placement above or below the SO results in similar success rates, stent patency duration, and stent occlusion rates. Significantly fewer complications, with a trend toward lower rates of pancreatitis, were observed for SEMS placed above the SO.

Background and Aims: Endoscopic transmural drainage/debridement of pancreatic walled-off necrosis (WON) has been performed using double-pigtail plastic (DP), fully covered self-expanding metal stents (FCSEMSs), or the novel lumen-apposing fully covered self-expanding metal stent (LAMS). Our aim was to perform a retrospective cohort study to compare the clinical outcomes and adverse events of EUS-guided drainage/debridement of WON with DP stents, FCSEMSs, and LAMSs., Methods: Consecutive patients in 2 centers with WON managed by EUS-guided debridement were divided into 3 groups: (1) those who underwent debridement using DP stents, (2) debridement using FCSEMSs, (3) debridement using LAMSs. Technical success (ability to access and drain a WON by placement of transmural stents), early adverse events, number of procedures performed per patient to achieve WON resolution, and long-term success (complete resolution of the WON without need for further reintervention at 6 months after treatment) were evaluated., Results: From 2010 to 2015, 313 patients (23.3% female; mean age, 53 years) underwent WON debridement, including 106 who were drained using DP stents, 121 using FCSEMSs, and 86 using LAMSs. The 3 groups were matched for age, cause of the pancreatitis, WON size, and location. The cause of the patients' pancreatitis was gallstones (40.6%), alcohol (30.7%), idiopathic (13.1%), and other causes (15.6%). The mean cyst size was 102 mm (range, 20-510 mm). The mean number of endoscopy sessions was 2.5 (range, 1-13). The technical success rate of stent placement was 99%. Early adverse events were noted in 27 of 313 (8.6%) patients (perforation in 6, bleeding in 8, suprainfection in 9, other in 7). Successful endoscopic therapy was noted in 277 of 313 (89.6%) patients. When comparing the 3 groups, there was no difference in the technical success (P = .37). Early adverse events were significantly lower in the FCSEMS group compared with the DP and LAMS groups (1.6%, 7.5%, and 9.3%; P < .01). At 6-month follow-up, the rate of complete resolution of WON was lower with DP stents compared with FCSEMSs and LAMSs (81% vs 95% vs 90%; P = .001). The mean number of procedures required for WON resolution was significantly lower in the LAMS group compared with the FCSEMS and DP groups (2.2 vs 3 vs 3.6, respectively; P = .04). On multivariable analysis, DP stents remain the sole negative predictor for successful resolution of WON (odds ratio [OR], 0.18; 95% confidence interval, 0.06-0.53; P = .002) after adjusting for age, sex, and WON size. Although there was no significant difference between FCSEMSs and LAMSs for WON resolution, the LAMS was more likely to have early adverse events (OR, 6.6; P = .02)., Conclusions: EUS-guided drainage/debridement of WON using FCSEMSs and LAMSs is superior to DP stents in terms of overall treatment efficacy. The number of procedures required for WON resolution was significantly lower with LAMSs compared with FCSEMSs and DP stents., (Copyright © 2017 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background: Endoscopic placement of fully covered self-expanding metal stents (FCSEMS) to treat malignant dysphagia in patients with esophageal cancer significantly improves dysphagia; however, these stents have a high migration rate., Aim: To determine whether FCSEMS fixation using an endoscopic suturing device treated malignant dysphagia and prevented stent migration in patients with locally advanced esophageal cancer receiving neoadjuvant therapy when compared to patients with FCSEMS placement alone., Method: A review of patients with locally advanced esophageal cancer who underwent FCSEMS placement at 3 centers was performed. Patients were divided into two groups: Group A (n = 26) was composed of patients who underwent FCSEMS placement with suture placement, and Group B (n = 67) was composed of patients with FCSEMS placement alone., Results: There were no significant differences between Groups A and B in demographics, and tumor characteristics. The technical success rate for stent placement was 100 %. There was no difference between Groups A and B in the median stent diameter and stent lengths. Mean dysphagia score obtained at 1 week after stent placement had improved significantly from baseline (2.4 and 1, respectively, p < 0.001). Patients had a median follow-up of 4 months. Immediate adverse events were mild chest discomfort in 4 patients in Group A and 2 patients in Group B (p = 0.05), and significant acid reflux in 3 patient in Group A compared to 2 patients in Group B (p = 0.1). The stent migration rate was significantly lower in Group A compared to compared to Group B (7.7 vs 26.9 %, respectively, p = 0.004). There was a delayed perforation in 1 patient and 1 death due to aspiration pneumonia in Group B., Conclusion: Fixation of esophageal FCSEMSs by using an endoscopic suturing device in patients receiving neoadjuvant therapy was shown to be feasible, safe, and relatively effective at preventing stent migration compared to those who had stent placed alone.

Background: The aim of this study was to assess the operating characteristics of using the confocal endomicroscopy miniprobe (pCLE) compared to cholangioscopic targeted biopsies for the detection of malignancy in biliary tract strictures., Methods: We conducted a retrospective analysis of data of patients who underwent evaluation of indeterminate biliary strictures after inconclusive brush cytology. Only those patients with a final pathologic diagnosis or a conclusive >12 months follow-up were included. Patients were divided into 2 groups: those who underwent pCLE assessment (pCLE) and those who underwent cholangioscopic targeted biopsies (SB) of biliary strictures. Cholangioscopic biopsies were considered positive for malignancy when adenocarcinoma cells were identified. pCLE was considered positive for malignancy according to the Miami and Paris criteria., Results: A total of 195 patients (median age, 66 years; 54.9% male) were included; 61 underwent C-pCLE and 134 underwent SB. Patient and biliary stricture characteristics were similar in the 2 groups. Final diagnoses were cholangiocarcinoma (N.=93), pancreatic adenocarcinoma (N.=6); and benign strictures (N.=96). The overall sensitivity of pCLE and SB for the detection of malignancy were 76.4% and 78.4% respectively (P=0.7). Similarly, there was no difference in the specificity of pCLE and CB for the diagnosis of malignancy (97.7% and 98.5% respectively; P=1). The diagnostic accuracy of pCLE was 83.6% versus 88.8% in SB (P=0.8). However, the specificity to detect a malignancy was higher for CB compared to pCLE (98.5 vs. 86.3%; P=0.04)., Conclusions: In patients with indeterminate bile duct strictures, cytology combined with pCLE has a similar sensitivity, and diagnostic accuracy when compared to cholangioscopic biopsies for the diagnosis of malignant strictures. pCLE may be beneficial for in vivo, real-time histopathologic examination of biliary strictures and help in the instantaneous characterization of biliary strictures.

Background & Aims: Plastic stents, placed via endoscopy to drain pancreatic fluid collections (PFCs), require repeat access. Covered metal stents are larger in diameter and can be inserted in a single step, but can migrate. We evaluated the safety and efficacy of a lumen-apposing, covered, self-expanding metal stent (LACSEMS) for PFC drainage., Methods: We performed a prospective study of the outcomes of stent placement in 33 patients (18 men; age, 53 ± 14 y; 28 with chronic pancreatitis) with symptomatic pancreatic pseudocysts and walled-off necrosis (≥ 6 cm with ≥ 70% fluid content). Subjects were enrolled at 7 tertiary care centers (6 in the United States and 1 in Europe) from October 2011 through August 2013. Cystenterostomies were created based on endoscopist preference. Safety outcomes included infection, bleeding, perforation, tissue injury, and stent migration. Efficacy end points included LACSEMS placement, patency, and removal, as well as 50% or more reduction in PFCs., Results: The mean size of the patients' PFCs was 9 ± 3.3 cm. LACSEMSs were placed successfully via endoscopic ultrasound guidance in 30 patients (91%); the remaining 3 patients received 2 double-pigtail stents. One subject could not be evaluated because of a pseudoaneurysm. In the patients receiving LACSEMS, PFCs resolved in 27 of 29 (93%). Overall, PFCs resolved in 30 of 33 patients (91%). Endoscopic debridement through the LACSEMS was conducted in 11 subjects. Complications (15%) included abdominal pain (n = 3), spontaneous stent migration, back pain (n = 1), access-site infection, and stent dislodgement (n = 1)., Conclusions: LACSEMS were placed successfully in 91% of subjects with PFCs. Overall, 93% had PFC resolution. Advantages of LACSEMSs over other stents include single-step deployment and the ability to perform endoscopic debridement with minimal stent migration. Clinicaltrials.gov: NCT01419769., (Copyright © 2015 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background and Objectives: Data on the risk of acute pancreatitis following endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) of pancreatic cystic lesions are limited. The aim of our study was to evaluate the frequency of acute pancreatitis after EUS-FNA of pancreatic cysts and solid lesions, and determine whether there was a difference in pancreatitis risk in patients with side branch intraductal papillary mucinous neoplasms (SB-IPMN)., Patients and Methods: A retrospective review of patients who underwent EUS-FNA of pancreatic cysts and solid lesions was performed. The primary outcome measure was development of acute pancreatitis after EUS-FNA. Factors associated with acute pancreatitis were examined by statistical analysis to determine independent predictors of acute pancreatitis. Statistical significance was determined at a P ≤ 0.05., Results: We identified 186 patients with pancreatic cystic lesions and 557 with solid lesions in which EUS-FNA was performed. The median size of the cysts was 19 mm (range: 10-66 mm). There were 37 IPMNs, 33 mucinous cystic neoplasms, 58 serous cysts and 46 pseudocysts and 12 solid-cystic ductal carcinomas. The majority of patients (75%) with solid lesions were diagnosed with adenocarcinoma. Patients with pancreatic cysts had a statistically greater frequency of developing pancreatitis after EUS-FNA when compared to those with solid lesions (2.6% vs. 0.36% respectively; P = 0.13). In patients with cysts, there were no statistically significant differences between the two groups (with and without pancreatitis) with regard to a cyst location, size of the cyst, and number of needle passes or trainee involvement. Patients with SB-IPMN had a statistically higher frequency of pancreatitis after EUS-FNA compared to those with other cyst types (8% vs. 1.3% respectively; odds ratio = 6.4, 95% confidence intervals = 1.0-40.3, P = 0.05)., Discussion: Patients with SB-IPMN are at a higher risk of developing acute pancreatitis after a EUS-FNA. Alternative means of diagnosis such as magnetic resonance cholangiopancreatogram might be necessary to avoid risk of EUS-FNA.

Diagnosis of fine-needle aspirations of pancreatic solid masses is complicated by many factors that keep its false-negative rate high. Our novel approach analyzes cell-free cytocentrifugation supernatant, currently a discarded portion of the specimen. Supernatant and cytology slides were collected from 25 patients: 11 cases with confirmed outcome [five positive (adenocarcinoma) and six negative (inflammatory states)], plus 14 without confirmed outcomes. Slides were microdissected, DNA was extracted from microdissections and corresponding supernatants, and all were analyzed for KRAS point mutation and loss of heterozygosity. Notably, higher levels of free DNA were found in supernatants than in corresponding microdissected cells. Supernatants contained sufficient DNA for mutational profiling even when samples contained few to no cells. Mutations were present in 5/5 malignancies and no mutations were present in inflammatory states. In conclusion, these findings support using supernatant for mutational genotyping when diagnostic confirmation is required for pancreatic solid masses., (Copyright © 2013 Wiley Periodicals, Inc.)

Background and Aim: Osteopontin (OPN) is a phosphoprotein that activates pathways that induce cancer cell survival and metastasis. Our aim was to examine the expression pattern of OPN splice variants a, b, and c in fine-needle aspirates and to determine their correlation with stage-adjusted pancreatic ductal adenocarcinoma (PDA) survival., Methods: Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) was performed in patients with solid pancreatic masses. The tissue was collected and analyzed for the expression of OPN isoforms by reverse transcription-polymerase chain reaction. Survival curves of stages and overexpression of OPN splice variants (a, b, c) were estimated according to the Kaplan-Meier and the log-rank test., Results: EUS-FNA was performed in 46 patients with solid pancreatic lesions (40 PDA and 6 chronic pancreatitis). OPNa was highly expressed in 39/40 (98%), OPNb in 24/40 (60%), while OPNc was present in 10/40 (25%) of PDA samples. The median survival was lower in patients whose fine-needle aspiration (FNA) samples expressed OPNb than those without (406 days vs 749 days, P = 0.049). There was no significant difference in survival in patients with OPNc. Cox proportional hazard model demonstrated that OPNb expression had a trend toward decrease overall survival (P = 0.06), with these patients having a hazard of death three times higher than those without. OPNc was found to significantly correlate with metastatic disease (P = 0.009) in PDA patients., Conclusions: Our data show for the first time that in FNA samples, there is a strong association between OPNc and presence of metastasis in PDA, and OPNb and poor survival., (© 2014 Journal of Gastroenterology and Hepatology Foundation and Wiley Publishing Asia Pty Ltd.)

Aim: To compare efficacy and complications of partially covered self-expandable metal stent (pcSEMS) to plastic stent (PS) in patients treated for malignant, infrahilar biliary obstruction., Methods: Multicenter prospective randomized clinical trial with treatment allocation to a pcWallstent(®) (SEMS) or a 10 French PS. Palliative patients aged ≥ 18, for infrahilar malignant biliary obstruction and a Karnofsky performance scale index > 60% from 6 participating North American university centers. Primary endpoint was time to stent failure, with secondary outcomes of death, adverse events, Karnofsky performance score and short-form-36 scale administered on a three-monthly basis for up to 2 years. Survival analyses were performed for stent failure and death, with Cox proportional hazards regression models to determine significant predictive characteristics., Results: Eighty-five patients were accrued over 37 mo, 42 were randomized to the SEMS group and 83 patients were available for analyses. Time to stent failure was 385.3 ± 52.5 d in the SEMS and 153.3 ± 19.8 d in the PS group, P = 0.006. Time to death did not differ between groups (192.3 ± 23.4 d for SEMS vs 211.5 ± 28.0 d for PS, P = 0.70). The only significant predictor was treatment allocation, relating to the time to stent failure (P = 0.01). Amongst other measured outcomes, only cholangitis differed, being more common in the PS group (4.9% vs 24.5%, P = 0.029). The small number of patients in follow-up limits longitudinal assessments of performance and quality of life. From an initially planned 120 patients, only 85 patients were recruited., Conclusion: Partially covered SEMS result in a longer duration till stent failure without increased complication rates, yet without accompanying measurable benefits in survival, performance, or quality of life.