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Goals: To describe the long-term outcomes of patients after EUS-guided gallbladder drainage (EUS-GBD), including those who underwent standardized stent exchanges for permanent plastic stents., Background: EUS-GBD has become one of the first-line alternatives for gallbladder decompression, with outcomes and safety profiles comparable to that of percutaneous gallbladder drainage. However, the long-term outcomes of EUS-GBD are not well-described. We report our single-center experience of a large cohort who underwent EUS-GBD., Study: Patients who underwent EUS-GBD from August 2014 to December 2022 were included in the study. Patient demographics, comorbidities, and procedure details were recorded. Patients were followed until complete stent removal, end of study period, or death. Short and long-term outcomes include technical and clinical success, stent patency, recurrent cholecystitis, cholecystectomy, and death., Results: During the study period, 128 patients were included. One hundred and one patients had benign indications for EUS-GBD, including cholecystitis and choledocholithiasis. Of those with malignant indications, 23 of 27 had distal malignant biliary obstruction. Technical and clinical successes were 95.3% and 95.1%, respectively. Stents were exchanged for 2 permanent double pigtail plastic stents in 43.0%. The mean stent patency was 421 days (488 d among those still alive) without any recurrent cholecystitis., Conclusion: EUS-GBD demonstrates prolonged stent patency and minimal long-term adverse events, particularly among patients who underwent stent exchanges for permanent plastic stents. EUS-GBD is also promising for patients presenting with choledocholithiasis and biliary colic who are not surgical candidates., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Competing Interests: Theodore W. James declares that he has no conflict of interest.Todd H. Baron: Boston Scientific, Olympus, Cook Endoscopy.

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.)

Background: Larger caliber lumen-apposing stents (LAMSs) have been increasingly used in the management of pancreatic fluid collections, specifically when solid debris is present; however, their advantages over smaller caliber plastic stents in the management of pancreatic pseudocysts are unclear. The aim of this study was to investigate the safety and efficacy of LAMS specifically in the management of pancreatic pseudocysts compared with double-pigtail plastic stents (DPPSs)., Methods: We performed a multicenter, international, retrospective study between January 2012 and August 2016. A total of 205 patients with a diagnosis of pancreatic pseudocysts were included, 80 patients received LAMSs and 125 received DPPSs. Measured outcomes included clinical success, technical success, adverse events, stent dysfunction, pancreatic pseudocyst recurrence, and need for surgery., Results: Technical success was similar between the LAMS and the DPPS groups (97.5 % vs. 99.2 %; P  = 0.32). Clinical success was higher for LAMSs than for DPPSs (96.3 % vs. 87.2 %; P  = 0.03). While the need for surgery was similar between the two groups (1.3 % vs. 4.9 %, respectively; P  = 0.17), the use of percutaneous drainage was significantly lower in the LAMS group (1.3 % vs. 8.8 %; P  = 0.03). At 6-month follow-up, the recurrence rate was similar between the groups (6.7 % vs 18.8 %, respectively; P  = 0.12). The rate of adverse events was significantly higher in the DPPS group (7.5 % vs. 17.6 %; P  = 0.04). There was no difference in post-procedure mean length of hospital stay (6.3 days [standard deviation 27.9] vs. 3.7 days [5.7]; P  = 0.31)., Conclusion: When compared to DPPSs, LAMSs are a safe, feasible, and effective modality for the treatment of pancreatic pseudocysts and are associated with a higher rate of clinical success, shorter procedure time, less need for percutaneous interventions, and a lower overall rate of adverse events., Competing Interests: S. Friedland is a consultant for Boston Scientific and C2 Therapeutics; T. Stevens is a speaker and consultant for Boston Scientific and a speaker for AbbVie pharmaceuticals; C. J. DiMaio is a consultant for Boston Scientific and Medtronic; L. H. Jamil is a consultant for Aries pharmaceutical; P. S. Yachimski is a consultant for Boston Scientific; J. Nieto is a consultant for Boston Scientific; V. Kumbhari is a consultant for ReShape Life Sciences, Apollo Endosurgery, Medtronic, and Boston Scientific, and has received consulting fees from Pentax Medical and C2 Therapeutics; V. Singh is a consultant for Abbvie, D-Pharm, and Santarus; E. J. Shin is a consultant for Boston Scientific and C2 Therapeutics; M. Khashab is a consultant for Boston Scientific and Olympus, and is also on the medical advisory board for Boston Scientific and Olympus. All other co-authors have no conflict of interest disclosures., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background and Aims: EUS-guided biliary drainage has emerged as a technique to enable endobiliary drainage in failed ERCP. A newer model, lumen-apposing metal stents (LAMS), with a cautery-enhanced delivery system became available in the USA in late 2015. This cautery-tipped version may facilitate EUS-guided choledochoduodenostomy (EUS-CD), but data using this model are lacking., Methods: We reviewed outcomes of attempted EUS-CD using cautery-enhanced LAMS from 6, US centers. The following data were collected: patient and procedure details, technical success, adverse events, clinical success (resolution of jaundice or improvement in bilirubin > 50%), and biliary re-interventions., Results: EUS-CD was attempted in 67 patients (mean age 68.8) with malignant obstruction after failed ERCP between September 2015 and April 2018. EUS-CD was technically successful in 64 (95.5%). A plastic or metal stent was inserted through the lumen of the deployed LAMS in 50 of 64 (78.1%) patients to maintain a non-perpendicular LAMS axis into the bile duct. Adverse events occurred in 4 (6.3%) and included: abdominal pain (n = 2), peritonitis that responded to antibiotics (n = 1), and bleeding requiring transfusion (n = 1). Among 40 patients with follow-up of > 4 weeks, clinical success was achieved in 100%. Biliary re-interventions for obstruction were needed in 7(17.5%), in 3 of 6 (50.0%) that underwent EUS-CD with LAMS alone versus 4 of 34 (5%) with LAMS plus an axis-orienting stent (p = 0.02)., Conclusion: EUS-CD using LAMS with cautery-enhanced delivery systems has high technical and clinical success rates, with a low rate of adverse events. Inserting an axis-orienting stent through the lumen of the LAMS may reduce the need for biliary re-interventions.

In recent years, the management of symptoms of pancreatic fluid collections has shifted from surgical and percutaneous interventions to endoscopic techniques. Available data show that endoscopic drainage can be achieved with minimal morbidity and procedural-related mortality, a high degree of technical and clinical success, and acceptable risk of adverse events. Although endoscopic management of walled-off necrosis provides a durable, minimally invasive treatment option, it is still generally performed only in tertiary care medical centers because of the overall complexity of this clinical scenario., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background and Aims: Endoscopic enteral stenting (ES) in malignant gastric outlet obstruction (GOO) is limited by high rates of stent obstruction. EUS-guided gastroenterostomy (EUS-GE) is a novel procedure that potentially offers sustained patency without tumor ingrowth/overgrowth. The aim of this study is to compare EUS-GE with ES in terms of (1) symptom recurrence and need for re-intervention, (2) technical success (proper stent positioning as determined via endoscopy and fluoroscopy), (3) clinical success (ability to tolerate oral intake without vomiting), and (4) procedure-related adverse events (AEs)., Methods: Multicenter retrospective study of all consecutive patients who underwent either EUS-GE at four centers between 2013 and 2015 or ES at one center between 2008 and 2010., Results: A total of 82 patients (mean age 66-years ± 13.5 and 40.2% female) were identified: 30 in EUS-GE and 52 in ES. Technical and clinical success was not significantly different: 86.7% EUS-GE versus 94.2% ES (p = 0.2) and 83.3% EUS-GE versus 67.3% ES (p = 0.12), respectively. Symptom recurrence and need for re-intervention, however, was significantly lower in the EUS-GE group (4.0 vs. 28.6%, (p = 0.015). Post-procedure mean length of hospitalization was comparable at 11.3 days ± 6.6 for EUS-GE versus 9.5 days ± 8.3 for ES (p = 0.3). Rates and severity of AEs (as per the ASGE lexicon) were also similar (16.7 vs. 11.5%, p = 0.5). On multivariable analysis, ES was independently associated with need for re-intervention (OR 12.8, p = 0.027)., Conclusion: EUS-GE may be ideal for malignant GOO with comparable effectiveness and safety to ES while being associated with fewer symptom recurrence and requirements for re-intervention.

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: 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.)

Introduction: Endoscopic ultrasound guided translumenal drainage of pancreatic fluid collections (PFCs) has been widely practiced for over a decade, using conventional plastic and self-expandable metal stents. The use of such stents for transmural drainage is off-label and limited by the lack of lumen-to-lumen anchorage, which can lead to leakage, migration and tissue trauma., Areas Covered: Novel stent designs dedicated to applications of translumenal drainage have recently emerged and promise to make transmural drainage quicker, safer, and more effective. Achieving faster resolution of the fluid collection, decreasing adverse events, decreasing recurrence rates, and lowering costs are critical to advancing the endoscopic management of PFCs. Expert commentary: Our paper suggests that the AXIOS stent is an innovative therapeutic approach for PFC drainage with excellent efficacy, safety, and relatively few adverse outcomes. Preliminary reports appear promising and large multicenter prospective studies are needed in the future to further determine its safety and efficacy.

Background: The combination of prophylactic pancreatic stent placement (PSP) - a temporary plastic stent placed in the pancreatic duct - and rectal non-steroidal anti-inflammatory drugs (NSAIDs) is recommended for preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in high-risk cases. Preliminary data, however, suggest that PSP may be unnecessary if rectal NSAIDs are administered. Given the costs and potential risks of PSP, we aim to determine whether rectal indomethacin obviates the need for pancreatic stent placement in patients undergoing high-risk ERCP., Methods/design: The SVI (Stent vs. Indomethacin) trial is a comparative effectiveness, multicenter, randomized, double-blind, non-inferiority study of rectal indomethacin alone versus the combination of rectal indomethacin and PSP for preventing PEP in high-risk cases. One thousand four hundred and thirty subjects undergoing high-risk ERCP, in whom PSP is planned solely for PEP prevention, will be randomized to indomethacin alone or combination therapy. Those who are aware of study group assignment, including the endoscopist, will not be involved in the post-procedure care of the patient for at least 48 hours. Subjects will be assessed for PEP and its severity by a panel of independent and blinded adjudicators. Indomethacin alone will be declared non-inferior to combination therapy if the two-sided 95 % upper confidence bound of the treatment difference is less than 5 % between the two groups. Biological specimens will be obtained from trial participants and centrally banked., Discussion: The SVI trial is designed to determine whether PSP remains necessary in the era of NSAIDs pharmacoprevention. The associated bio-repository will establish the groundwork for important scientific breakthrough., Trial Registration: NCT02476279, registered June 2015.

Patients with acute cholecystitis sometimes require placement of percutaneous cholecystostomy catheters, either as a bridge to surgery or as primary therapy. In patients who cannot undergo surgery, subsequent removal of the catheter can lead to recurrence of cholecystitis, whereas leaving the drain in place can cause adverse events. We investigated internalization of percutaneous cholecystostomy drainage catheters, using endoscopic ultrasound (EUS)-guided placement of lumen-apposing metal stents (LAMS) as an alternative treatment strategy. Seven patients (median age, 57 years; 6 men) underwent EUS-guided cholecystoenterostomy for internalization of gallbladder drainage with EUS-guided placement of a 10- or 15-mm LAMS. All had initially been treated with placement of a percutaneous cholecystostomy catheter for cholecystitis and were later deemed unfit for cholecystectomy. Technical success was achieved in all patients in 1 endoscopic session, with subsequent removal of all percutaneous drains. Two patients required placement of self-expandable metal stents within the LAMS to successfully bridge the gallbladder and gastrointestinal lumen. No adverse events occurred after a median follow-up of 2.5 months. EUS-guided cholecystoenterostomy using a LAMS is therefore a viable option for internal gallbladder drainage in patients who have a percutaneous cholecystostomy catheter and are poor candidates for cholecystectomy., (Copyright © 2016 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Nonsurgical techniques for gallbladder drainage are percutaneous, and endoscopic. EUS-guided transmural gallbladder drainage (EUS-GBD) is a relatively new approach, although data are limited. Our aim was to describe the outcome after EUS-GBD with a lumen-apposing metal stent (LAMS)., Patients and Methods: This was a retrospective review of prospectively collected data on 15 nonsurgical patients who underwent EUS-GBD for various indications. Procedures were performed at 3 tertiary care centers with expertise in the management of complex biliary problems. The main outcome measures were technical and clinical success and adverse events., Results: Fifteen patients (8 male, 7 female) with a median age of 74 years (range 42-89) underwent EUS-GBD by using a LAMS to decompress the gallbladder (7 patients calculous cholecystitis, 4 acalculous cholecystitis, 2 patients biliary obstruction, 1 patient gallbladder hydrops, 1 patient symptomatic cholelithiasis). Patients were nonsurgical candidates according to the American Society of Anesthesiologists Physical Status Classification System; findings were class IV or higher in 9 patients and advanced malignancies in 6. Percutaneous transhepatic gallbladder drainage (PT-GBD) was refused by all patients and was further precluded by perihepatic ascites in 3 patients, coagulopathy or need for anticoagulation in 4 patients, and need for internal biliary drainage in 2 patients. Transduodenal access and stenting was achieved in 14 of 15 patients and transgastric stenting was achieved in 1. Technical success was achieved in 14 of 15 patients (93%), whereas clinical success was achieved in all 15 patients with a median follow-up of 160 days. One mild adverse event (postprocedure fever for 3 days) was noted. The limitations of this study are the small select group of patients and retrospective study design., Conclusions: EUS-GBD with a LAMS is technically safe and effective for decompressing the gallbladder for cholecystitis and biliary or cystic duct obstruction in patients who are poor surgical candidates., (Copyright © 2015 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aim: Selected patients with unresectable perihilar cholangiocarcinoma can undergo neoadjuvant chemoradiotherapy followed by liver transplantation, which has been shown to improve survival. The aim of this study was to determine the feasibility and safety of endoscopic transpapillary insertion of nasobiliary tubes (NBTs) and brachytherapy catheters for high dose-rate (HDR) brachytherapy as part of this neoadjuvant chemoradiotherapy., Patients and Methods: Medical records of patients undergoing biliary brachytherapy for hilar cholangiocarcinoma at the Mayo Clinic, Rochester were reviewed. Patients were treated with curative intent using external beam radiotherapy (4500 cGy), chemotherapy (5-FU or capecitabine), and HDR brachytherapy (930 - 1600 cGy in one to four fractions delivered over 1 - 2 days) prior to planned liver transplantation., Results: Between 2009 and 2013, 40 patients underwent biliary HDR brachytherapy via endoscopically placed NBTs (8.5 - 10 Fr). Patients had a median age of 55 years (range 28 - 68); 25 patients (62.5 %) had primary sclerosing cholangitis. Prior to therapy, 29 patients (72.5 %) had plastic stents, two (5 %) had metal stents, and nine (22.5 %) had no stents. Bilateral NBTs were placed in five patients (12.5 %). NBT/brachytherapy catheter displacement was seen in eight patients (20 %) - five intraprocedure and three post-procedure. A radiotherapy error and NBT kinking each occurred once. Post-procedure adverse events included: cholangitis (n = 5; 12.5 %), severe abdominal pain (n = 3; 7.5 %), duodenopathy (n = 3; 7.5 %), gastropathy (n = 3; 7.5 %), and both duodenopathy and gastropathy (n = 2; 5 %)., Conclusion: HDR biliary brachytherapy administered via endoscopically placed NBTs and brachytherapy catheters is technically feasible and appears reasonably safe in selected patients with unresectable perihilar cholangiocarcinoma., (© Georg Thieme Verlag KG Stuttgart · New York.)

Endoscopic stenting has become a widely method for the management of various malignant and benign pancreatico-biliary disorders. Biliary and pancreatic stents are devices made of plastic or metal used primarily to establish patency of an obstructed bile or pancreatic duct and may also be used to treat biliary or pancreatic leaks, pancreatic fluid collections and to prevent post-endoscopic retrograde cholangiopancreatography pancreatitis. In this review, relevant literature search and expert opinions have been used to evaluate the outcome of stenting in biliary and pancreatic benign and malignant diseases.

Background and Study Aims: Recently, a novel fully covered and biflanged metal stent (BFMS)dedicated to the drainage of walled-off necrosis(WON) was developed. The aim of this study was to retrospectively evaluate the safety, efficacy, and cost performance of drainage of WON using the novel BFMS compared with a traditional plastic stent., Patients and Methods: A total of 70 patients with symptomatic WON were treated under endoscopic ultrasound (EUS) guidance. Initial drainage was conducted using the single gateway technique with placement of one or more plastic stents or a single BFMS.If drainage was unsuccessful,direct endoscopic necrosectomy (DEN)was performed., Results: There were no statistically significant differences in rates of technical success, clinical success,and adverse events between plastics stents and BFMS, despite the size of WON in the BFMS group being significantly larger than that in the plastic stent group (105.6 vs. 77.1 mm; P=0.003).The mean procedure times for the first EUS-guided drainage and for re-intervention were significantly shorter in the BFMS group than in the plastic stent group (28.8±7.1 vs. 42.6±14.2, respectively,for drainage, P<0.001; and 34.9±8.5 vs.41.8±7.6, respectively, for re-intervention, P<0.001). There was no statistically significant difference in the total cost between plastic stent and BFMS use in the treatment of WON ($5352vs. $6274; P=0.25)., Conclusions: Plastic stents and BFMS were safe and effective for the treatment of WON. In particular,BFMS placement appeared to be preferable for initial EUS-guided drainage and additional reintervention(e.g. DEN) as it reduced the procedure time. Prospective randomized controlled trials are warranted.

Purpose of Review: To determine trends in pancreaticobiliary stents over the past 12-18 months., Recent Findings: Metal biliary stents continue to be used for palliation of malignant distal biliary obstruction with superior patency to plastic stents. The use of covered metal biliary stents is increasingly being used for the management of benign biliary disease. Plastic stents predominate in patients with pancreatic disease, with the exception of transmural drainage of pancreatic necrosis. In both biliary and pancreatic disorders, there is a trend towards greater utilization of endoscopic ultrasound-guided interventions., Summary: Endoscopic placement of pancreaticobiliary stents plays an important role in the treatment of complex benign and malignant disease. Further comparative trials are needed to determine the optimal role of endoscopic ultrasound-guided transmural stent placement.

Background: Walled-off pancreatic necrosis (WOPN) is effectively managed with percutaneous and endoscopic techniques such as direct endoscopic necrosectomy. However, they require repeat interventions and lengthy hospital stays., Objective: To evaluate a new platform to manage WOPNs by using a large-bore, through-the-scope, fully covered, self-expandable metal stent (FCSEMS) to overcome the need for repeat interventions and extended hospital stays., Design: Retrospective, single-center study., Setting: Academic tertiary care center., Patients: Five consecutive patients with symptomatic WOPN underwent EUS-guided drainage of WOPN by using a large-bore FCSEMSs., Interventions: EUS-guided transgastric drainage of WOPN by using a large-bore FCSEMS. Cross-sectional imaging was repeated at 6- to 8-week intervals. The FCSEMS was removed after WOPN resolution., Main Outcome Measurements: Clinical success, number of repeat interventions, and length of hospital stay., Results: Five patients (mean age 60 years) with WOPN (mean diameter, 12.3 cm; range 9.8-14.3 cm) underwent drainage with the described technique. Technical and clinical success was achieved in 100% of patients. Direct endoscopic necrosectomy was not required in any patient. The median number of endoscopic procedures was 1. The median length of hospital stay was 1 day. There were no adverse events., Limitations: Small, retrospective study., Conclusions: The described novel platform facilitates resolution of WOPN with a single procedure, avoiding the need for repeat interventions and lengthy hospital stays., (Copyright © 2014 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: The use of endoluminal stents has been proposed for the management of fistulas and anastomotic strictures after bariatric surgery. The objective of our study was to determine the success of endoscopically placed, self-expandable metal stents (SEMS) in bariatric patients specifically with either chronic persistent anastomotic or staple line leaks/fistulas or chronic, persistent anastomotic strictures., Methods: We treated 21 patients including 5 with chronic staple line leaks/fistulas (4 from the gastric sleeve after biliopancreatic diversion with duodenal switch [BPD/DS] and 1 after removal of an eroding laparoscopic adjustable gastric band) and 16 with chronic anastomotic strictures (15 at the gastrojejunostomy after Roux-en-Y gastric bypass and 1 at the duodenoileal anastomosis after BPD/DS). Patients with early leaks or anastomotic strictures were excluded., Results: All but one of these patients had been referred to our institution after chronic treatment elsewhere was unsuccessful with prior stent placement for fistulas or multiple endoscopic dilations for strictures. Their bariatric operations had been performed a mean of 386 days beforehand. Stent placement was performed successfully in all patients without complications but was successful in only 4 of 21 patients (19%)-2 with chronic fistulas and 2 with chronic anastomotic strictures. Stent migration occurred in 10 patients (47%); the migrated stents were removed/replaced endoscopically in 7 patients but required elective operative removal in 3 with concomitant correction of the leak, fistula, or anastomotic stricture; none were operated emergently., Conclusion: Only 4 of 21 patients with a chronic persistent leak or anastomotic stricture were treated definitively using a SEMS. Although endoluminal stents may not lead to resolution of a chronic leak or stricture, SEMS may suppress ongoing sepsis and allow patients to undergo nutritional resuscitation orally before operative correction., (Copyright © 2014 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Recent studies suggest that there is a substantial risk of perforation after colorectal stent placement., Objective: To identify risk factors for perforation from colonic stenting., Design: A meta-analysis of 86 studies published between 2005 and 2011., Setting: Multicenter review., Patients: All patients who underwent colorectal stent placement., Intervention: Colorectal stent placement., Main Outcome Measurements: The occurrence of perforation with subgroup analyses for stent design, stricture etiology, stricture dilation, and concomitant chemotherapy, including the use of bevacizumab., Results: A total of 4086 patients underwent colorectal stent placement; perforation occurred in 207. Meta-analysis revealed an overall perforation rate of 7.4%. Of the 9 most frequently used stent types, the WallFlex, the Comvi, and the Niti-S D-type had a higher perforation rate (>10%). A lower perforation rate (<5%) was found for the Hanarostent and the Niti-S covered stent. Stenting benign strictures was associated with a significantly increased perforation rate of 18.4% compared with 7.5% for malignant strictures. Dilation did not increase the risk of perforation: 8.5% versus 8.5% without dilation. The subgroup of post-stent placement dilation had a significantly increased perforation risk of 20.4%. With a perforation rate of 12.5%, bevacizumab-based therapy was identified as a risk factor for perforation, whereas the risk for chemotherapy without bevacizumab was 7.0% and not increased compared with the group without concomitant therapies during stent therapy (9.0%)., Limitations: Heterogeneity; a considerable proportion of data is unavailable for subgroup analysis., Conclusions: The perforation rate of colonic stenting is 7.4%. Stent design, benign etiology, and bevacizumab were identified as risk factors for perforation. Intraprocedural stricture dilation and concomitant chemotherapy were not associated with an increased risk of perforation., (Copyright © 2014 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background and Aims: Traditional endoscopic management of benign biliary strictures (BBS) consists of placement of one or more plastic stents. Emerging data support the use of covered self-expandable metal stents (CSEMS). We sought to assess outcome of endoscopic temporary placement of CSEMS in patients with BBS., Methods: This was a retrospective study of CSEMS placement for BBS between May 2005 and July 2012 from two tertiary care centers. A total of 145 patients (81 males, median age 59 years) with BBS were identified; 73 of which were classified as extrinsic and were caused by chronic pancreatitis, and 70 were intrinsic. Main outcome measures were resolution of stricture and adverse events (AEs) due to self-expandable metal stents (SEMS)-related therapy., Results: Fully covered and partially covered 8-10 mm diameter SEMS were placed and subsequently removed in 121/125 (97 %) attempts in BBS (failure to remove four partially covered stents). Stricture resolution occurred in 83/125 (66 %) patients after a median stent duration of 26 weeks (median follow-up 90 weeks). Resolution of extrinsic strictures was significantly lower compared to intrinsic strictures (31/65, 48 % vs. 52/60, 87 %, p = 0.004) despite longer median stent duration (30 vs. 20 weeks). Thirty-seven AEs occurred in 25 patients (17 %), with 12 developing multiple AEs including cholangitis (n = 17), pancreatitis (n = 5), proximal stent migration (n = 3), cholecystitis (n = 2), pain requiring SEMS removal and/or hospitalization (n = 3), inability to remove (n = 4), and new stricture formation (n = 3)., Conclusions: Benign biliary strictures can be effectively treated with CSEMS. Successful resolution of biliary strictures due to extrinsic disease is seen significantly less often than those due to intrinsic disease. Removal is successful in all patients with fully covered SEMS.

Background and Study Aim: Controversy exists on optimal endoscopic management for palliation of malignant hilar obstruction, with advocates for metal "side-by-side" (SBS) and "stent-in-stent" (SIS) techniques. We sought to evaluate the technical feasibility, efficacy, and outcomes of bilateral biliary self-expanding metal stents (SEMS) for treatment of malignant hilar obstruction using a stent with a 6Fr delivery system., Patients and Methods: This was a single-center, retrospective review of all patients who underwent bilateral placement of Zilver® biliary SEMS for malignant hilar obstruction from January 2010 to August 2012. Patients underwent endoscopic retrograde cholangiopancreatography with placement of stents using either the SIS or SBS stent techniques., Results: Twenty-four patients (19 men, mean age 63 years) underwent bilateral stenting for malignant hilar obstruction during the study period. Seventeen and seven patients underwent the SBS and SIS technique, respectively. Cholangiocarcinoma (n=14) was the most common cause of hilar obstruction. Initial technical success was achieved in 24/24 (100%) of patients; however, 12 (50%) patients required re-intervention during the study period (median 98 days). Comparison of the SBS and SIS groups revealed no statistical difference with respect to need for re-intervention (P=0.31), successful re-intervention (P=0.60), or procedural length (P=0.89)., Conclusions: Use of bilateral Zilver® SEMS in either the SBS or SIS configuration is safe, technically feasible, and effective for drainage of malignant hilar obstruction; however, duration of stent patency and procedure-free survival remain variable.

Background & Aims: Placement of pancreatic duct (PD) stents prevents pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). There is evidence that rectal administration of nonsteroidal anti-inflammatory drugs (NSAIDs) also prevents post-ERCP pancreatitis, but the 2 approaches alone have not been compared directly. We conducted a network meta-analysis to indirectly compare the efficacies of these procedures., Methods: PubMed and Embase were searched by 2 independent reviewers to identify full-length clinical studies, published in English, investigating use of PD stent placement and rectal NSAIDs to prevent post-ERCP pancreatitis. We identified 29 studies (22 of PD stents and 7 of NSAIDs). We used network meta-analysis to compare rates of post-ERCP pancreatitis among patients who received only rectal NSAIDs, only PD stents, or both., Results: Placement of PD stents and rectal administration of NSAIDs were each superior to placebo in preventing post-ERCP pancreatitis. The combination of rectal NSAIDs and stents was not superior to either approach alone. Pooled results showed that rectal NSAIDs alone were superior to PD stents alone in preventing post-ERCP pancreatitis (odds ratio, 0.48; 95% confidence interval, 0.26-0.87)., Conclusions: Based on a network meta-analysis, rectal NSAIDs alone are superior to PD stents alone in preventing post-ERCP pancreatitis, and should be considered first-line therapy for selected patients. However, these findings were limited by the small number of studies assessed (only 29 studies), potential publication bias, and the indirect nature of the comparison. High-quality, randomized, controlled trials are needed to compare these 2 interventions and confirm these findings., (Copyright © 2013 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background: Esophageal self-expandable stents (SESs) effectively treat strictures and leaks but may be complicated by a stent-associated esophagorespiratory fistula (SERF). Little is known about SERFs., Objective: To determine the incidence, morbidity, mortality, and risk factors for SERF., Design: Retrospective case-control study., Setting: Single referral center., Patients: All adults undergoing esophageal SES placement during a 10-year period., Intervention: Stent placement., Main Outcome Measurements: Occurrence of SERF, morbidity, and mortality., Results: A total of 16 of 397 (4.0%) patients developed SERF at a median of 5 months after stent placement (range 0.4-53 months) including 6 of 94 (6%), 10 of 71 (14%), and 0 of 232 (0%) of those with lesions in the proximal, middle, and distal esophagus, respectively (overall P < .001). SERF occurred in 10% of those with proximal and mid-esophageal lesions, including 14% with benign strictures, 9% with malignant strictures, and none with other indications for SES placement (P = .27). The risk was highest (18%) in patients with benign anastomotic strictures. Risk factors for development of SERF included a higher Charlson comorbidity index score (odds ratio [OR] 1.47 for every 1-point increase; P = .04) and history of radiation therapy (OR 9.41; P = .03). Morbidity associated with SERF included need for lifelong feeding tubes in 11 of 22 (50%) and/or tracheostomy or mechanical ventilation in 5 of 22 (23%). Median survival after diagnosis was 4.5 months (range 0.35-67), and 7 patients survived less than 30 days., Limitations: Retrospective design, limited statistical power., Conclusion: SERF is a morbid complication of SES placement for strictures of the proximal and mid-esophagus. The dominant risk factors for development of SERF are prior radiation therapy and comorbidity score., (Copyright © 2013 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Temporary placement of self-expandable stents has been increasingly used for the management of benign esophageal diseases., Objective: To evaluate the safety of endoscopic removal of esophageal self-expandable stents placed for the treatment of benign esophageal diseases., Design: Multicenter retrospective study., Setting: Six tertiary care centers in the United States and Europe., Patients: A total of 214 patients with benign esophageal diseases undergoing endoscopic stent removal., Intervention: Endoscopic stent removal., Main Outcome Measurements: Endoscopic techniques for stent removal, time to stent removal, and adverse events related to stent removal., Results: A total of 214 patients underwent a total of 329 stent extractions. Stents were mainly placed for refractory strictures (49.2%) and fistulae (49.8%). Of the removed stents, 52% were fully covered self-expandable metal stents (FCSEMSs), 28.6% were partially covered self-expandable metal stents (PCSEMSs), and 19.5% were self-expandable plastic stents. A total of 35 (10.6%) procedure-related adverse events were reported, including 7 (2.1%) major adverse events. Multivariate analysis revealed that use of PCSEMSs (P < .001) was a risk factor for adverse events during stent removal. Favorable factors for successful stent removal were FCSEMSs (P ≤ .012) and stent migration (P = .010). No significant associations were found for stent indwelling time (P = .145) and stent embedding (P = .194)., Limitations: Retrospective analysis, only tertiary care centers., Conclusions: With an acceptable major adverse event rate of 2.1%, esophageal stent removal in the setting of benign disease was found to be a safe and feasible procedure. FCSEMSs were more successfully removed than self-expandable plastic stents and PCSEMSs. Adverse events caused by stent removal were not time dependent., (Copyright © 2013 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: ERCP in Roux-en-Y gastric bypass (RYGB) patients is challenging. Balloon-assisted enteroscopy (BAE) allows access to the excluded stomach with creation of a percutaneous endoscopic gastrostomy (PEG). Transgastric self-expandable metal stent (SEMS) placement may allow antegrade ERCP in 1 session., Objective: To determine the feasibility of transgastric endoscopy and ERCP through a newly created PEG augmented by SEMS placement., Design: Prospective live animal study; human case report., Settings: Animal laboratory and endoscopy units, tertiary care medical center., Subjects: Nine domestic pigs; 1 patient., Interventions: PEG tract with SEMS placement; transgastric endoscopy through SEMS., Main Outcome Measurements: Technical success, feasibility of transgastric endoscopy., Results: Successful SEMS deployment was achieved in 9 of 9 animals. The stent was removed in 6 animals; 3 were killed within 24 hours (group A) and 3 were killed 1 week later (group B). In 3 animals, stents remained in place, they were killed 9 to 15 days later (group C). Duodenoscopy was difficult in 1 animal from group A resulting in stent dislodgment. Peristomal infection occurred in 1 animal in group B. In group C, 1 stent was buried subcutaneously and 1 completely migrated out. Necropsy showed no peritoneal fluid or peritonitis in any animal. In the 1 patient, BAE-assisted PEG and SEMS placement in the excluded stomach allowed antegrade ERCP and biliary sphincterotomy without adverse events., Limitations: Small number of subjects., Conclusions: Performance of PEG with immediate SEMS placement allows for antegrade transgastric ERCP during 1 procedure. With the use of BAE, retrograde PEG/SEMS in excluded stomach allows therapeutic ERCP without need for surgery., (Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)