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Background: An electrocautery-enhanced delivery system with a lumen-apposing metal stent (LAMS) is available for one-step endoscopic ultrasound-guided transmural drainage (EUS-TD). Bipolar electrosurgery has several potential clinical advantages, including reduced collateral thermal damage, enhanced hemostasis, and no requirement for a return electrode plate. In this study, we compared the technical feasibility and safety of a newly developed bipolar electrocautery-enhanced delivery system with a conventional delivery system for EUS-TD using a LAMS in a porcine model., Method: Ten days before the study, 12 mini pigs underwent common bile duct ligation for EUS-guided gallbladder drainage. Transenteric puncture was performed, followed by placement of a guidewire. In six pigs, a bipolar electrocautery-enhanced delivery system with LAMS (Hot SPAXUS) was inserted over the guidewire and advanced into the gallbladder, without prior dilation of the tract, by applying a bipolar cut current. In the remaining six pigs, a conventional delivery system with LAMS (Cold SPAXUS) was inserted after tract dilatation using a cystotome. The stent was removed after 4 weeks., Results: In all pigs, the stent was successfully inserted and deployed in the gallbladder without adverse events. The mean procedure time of EUS-TD was significantly lower in the Hot SPAXUS group than that of the Cold SPAXUS group (mean ± standard deviation: 188.7 ± 5.2 vs 449.5 ± 97.5 s, P = .0019). Stent migration was not observed, and all stents were removed successfully., Conclusions: Endoscopic ultrasound-guided transmural drainage using a bipolar electrocautery-enhanced LAMS is feasible for reducing the procedure time while maintaining the high success rate and safety of conventional LAMS., (© 2022 Japanese Society of Hepato-Biliary-Pancreatic Surgery.)

Background and Aim: There is no clear data to compare the effectiveness and safety of bilateral stent-in-stent (SIS) or stent-by-stent (SBS) deployment for advanced malignant hilar obstruction (MHO). This meta-analysis was done to investigate clinical outcomes of these deployment methods., Methods: We did a literature search to identify studies that reported the clinical outcomes of bilateral metal stents in patients with advanced MHO. Weighed pooled rates (WPR) along with 95% confidence interval (95% CI) were calculated in order to compare outcomes including technical and clinical success, adverse events, and stent occlusion between the two groups. We conducted a meta-analysis using a random-effects model., Results: Five comparative studies with 250 patients, and 20 single-arm studies for the SIS or SBS method were eligible for the meta-analysis and systematic review. The bilateral SIS deployment had a significantly higher technical success rate than did SBS deployment (OR 6.43; 95% CI 1.08-38.09). There was no difference in the clinical success (OR 1.23; 95% CI 0.45-3.38), overall adverse events rates (OR 0.42; 95% CI 0.15-1.18), or overall occlusion rate (OR 1.55; 95% CI 0.89-2.70). As a single-armed group, WPR of technical success of the SIS and SBS groups was 96.4% and 89.6%, respectively. Clinical success was 97.5% and 98.3%. Overall, adverse events were 35.9% and 22.6%. Occlusion rates were 27.7% and 37.7%., Conclusions: Although there was a lack of quality data and heterogeneity, bilateral SIS deployment had a higher technical feasibility than did the SBS method in patients with advanced MHO, without differences in terms of clinical success, adverse events, or occlusion rates., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC part of Springer Nature.)

Background and Aims: Electrocautery-tip lumen-apposing metal stents (EC-LAMSs) have extended the indications of therapeutic EUS. We aimed to retrospectively evaluate safety and technical and clinical success of a newly developed EC-LAMS, the Hot-Spaxus (Taewoong Medical Co, Gimpo, Korea), for various EUS-guided procedures., Methods: We included and retrospectively analyzed consecutive patients at 8 tertiary care referral centers who had undergone EUS interventional procedures using the Hot-Spaxus between October 2018 and February 2021., Results: Of 58 included patients (male-to-female, 36:22; mean age, 63.5 ± 14.9 years), 29 had undergone pancreatic fluid collection drainage (50%), 22 (37.9%) biliary drainage for malignant distal obstruction, 3 (5.1%) gallbladder drainage for acute cholecystitis, 3 gastroenteroanastomoses, and 1 (1.7%) pelvic collection drainage. Technical success was achieved in 54 of 58 patients (93.1%) and clinical success in all 58. Adverse events occurred in 6 patients (11.1%): 2 early (3.7%), 1 late (1.8%), and 3 long term (5.6%). The outcomes were similar to those observed in a control group of patients treated with the Hot-Axios (Boston Scientific, Marlborough, Mass, USA), the other available EC-LAMS., Conclusions: Our study showed that the novel EC-LAMS has high technical and clinical success rates for various interventional EUS indications. Future multicenter prospective studies will better clarify the role of this new EC-LAMS for different indications., (Copyright © 2022 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Fully covered self-expanding metal stents (FCSEMSs) are considered to be more effective than plastic stents for the treatment of main pancreatic duct (MPD) strictures associated with chronic pancreatitis (CP) because of their larger diameter and exertion of a radial expansion force. However, the current FCSEMSs have several limitations. To overcome these, a novel modified nonflared FCSEMS was developed. In this study we conducted a prospective long-term follow-up evaluation of the efficacy of the novel FCSEMS for the treatment of refractory benign PD strictures in patients with CP., Methods: Consecutive patients with symptomatic CP associated with refractory MPD strictures were enrolled prospectively in this single-arm study. The nonflared FCSEMS was placed intraductally or transpapillary according to the location and length of the stricture. Stent removal was performed at 3 months after placement. The primary outcome was the resolution of the pancreatic ductal stricture., Results: Endoscopic placement of modified nonflared FCSEMSs was technically successful in all 25 patients. Intraductal FCSEMS placement was performed in 14 patients (56.0%). Stents of diameter 8 mm were used in 17 patients (68.0%). Stents of lengths 3 and 5 cm were inserted in 22 (88.0%) and 3 (12.0%) patients, respectively. In 1 patient (4.0%), stent migration developed. All other stents were removed successfully. After stent removal, resolution of the MPD stricture was confirmed in all patients, and no FCSEMS-related de novo stricture was observed. During the follow-up period (median, 34 months; interquartile range, 25-56) after the stents had been removed from the 25 patients, reintervention for recurrence of MPD stricture with abdominal pain was performed in 2 patients (8.0%)., Conclusions: Endoscopic placement of a novel modified nonflared FCSEMS resulted in long-term stricture resolution with pain relief and reduced the rate of stent-related adverse events, particularly stent migration and stent-induced de novo MPD stricture. (Clinical trial registration number: UMIN000035681.)., (Copyright © 2020 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background: A novel self-approximating lumen-apposing metallic stent (LAMS; Niti-S Spaxus, Taewoong Medical, Gyeonggi-do, Korea) has recently become available. The aim of the present study was to evaluate the outcomes for drainage of pancreatic fluid collections (PFC)., Methods: This was a prospective international multicentered study conducted in six high-volume institutions across Asia. Consecutive patients suffering from pancreatic pseudocyst or walled-off pancreatic necrosis (WOPN) requiring endoscopic ultrasonography-guided drainage were recruited. Outcomes included technical and clinical success, adverse events, procedural events, interventions through the stent and recurrence rates., Results: Between August 2016 and November 2017, 59 patients were recruited to this study. Thirty-nine patients (66.1%) had WOPN and mean (SD) size of PFC was 11.5 (5.1) cm. Technical and clinical success rates were 100%. Mean (SD) procedural time was 35.0 (17.2) minutes. Sixteen-millimeter stents were used in 66.1% of the patients. Fifty-four sessions of necrosectomy were carried out with the stent in situ in 17 patients. Stent-related adverse event (AE) rate was 6.8%. Three patients (5.1%) suffered from bleeding after stenting and one required angiographic embolization. Two patients (3.4%) suffered from recurrence during a mean (SD) follow-up time of 325.6 (355.5) days. There were no differences in outcomes between those with pseudocysts or WOPN except for the duration of hospital stay (P = 0.012)., Conclusion: Use of a self-approximating LAMS for drainage of PFC was safe and effective. Endoscopic necrosectomy could be carried out through the stent with ease. The device was associated with a low rate of stent-related AE., (© 2019 Japan Gastroenterological Endoscopy Society.)

Background and Aim: Fully covered self-expandable metallic stent (FCSEMS) may be an effective modality for managing anastomotic biliary stricture (ABS) after liver transplantation. However, stent migration and stent-induced ductal injury are the main limitations. The objective of this study was to evaluate the usefulness of an unflared, intraductal FCSEMS that was designed to minimize migration and ductal injury for refractory ABS after living donor liver transplantation (LDLT)., Methods: A total of 32 consecutive patients with symptomatic ABS after LDLT unresolved by plastic stents with or without balloon dilation at four tertiary medical centers were prospectively enrolled. A short (3 or 5 cm) FCSEMS having long lasso (10 cm) used in this study had unflared convex ends to minimize tissue hyperplasia and smaller center portion to prevent migration. The FCSEMS was placed above the papilla and removed at 3-4 months after stenting., Results: Technical and clinical success rates of intraductal placement with FCSEMS were 100% (32/32) and 81.2% (26/32), respectively. Early stent migration was observed in five (15.6%) patients. However, three patients with early stent migration had stricture resolution without needing additional intervention. Intended stent removal was successful in 27 (100%) patients (median, 101 days; range, 23-118 days). No stent-induced ductal change was observed in all patients. Stricture recurrence was observed in 11.5% (3/26) of patients during 639 days of median duration of follow-up (range, 366-2079 days)., Conclusions: Intraductal placement of an unflared short FCSEMS may be a promising option for refractory ABS after LDLT with minimal stent-induced ductal injury and stent migration., (© 2019 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.)

Although endoscopic intervention is the mainstay for palliation of malignant biliary obstruction, a percutaneous approach has been preferred, particularly in patients with advanced high-grade hilar malignant biliary obstruction, because of the technical difficulty and risk of complications. However, recently, primary endoscopic palliation using plastic or metal stents has had higher technical and clinical success with fewer adverse events than the percutaneous approach. Endoscopic interventions are being done more and more frequently because of advances in metal stents, accessories, and techniques. However, several concerns, such as optimal stent type, number, and deployment method, remain to be resolved. Therefore, we reviewed the literature in order to identify the optimal biliary stenting strategy for patients with hilar malignant biliary obstruction, focusing on stent type (plastic vs metal), number (unilateral [single] vs bilateral [multiple]), and deployment method (stent-in-stent vs stent-by-stent)., (© 2019 Japan Gastroenterological Endoscopy Society.)

Background and Aims: Recently, a newly designed lumen-apposing metal stent (LAMS) with a conventional delivery system was developed. The purpose of this study was to evaluate the effectiveness and safety of a newly designed LAMS for EUS-guided drainage to treat symptomatic pancreatic pseudocysts., Methods: This prospective multicenter cohort study included 34 patients with symptomatic pancreatic pseudocysts from 2016 to 2017. The patients underwent EUS-guided drainage with the newly designed LAMS (Niti-S SPAXUS; Taewoong Medical Co, Ltd, Ilsan, South Korea). Effectiveness outcome measurements included technical success rate, clinical success rate, successful stent removal rate, and procedural time. Safety outcome measurements included procedure and/or stent-related adverse events (AEs) and overall AEs. Patients were prospectively followed, and consecutive data were collected at discharge, at stent removal, and 20 days after stent removal., Results: Thirty-four patients (mean age 51.7 ± 13.3 years, 26 men) were enrolled. The mean pseudocyst size was 9.23 ± 3.54 cm. The technical success rate was 97.1% (33/34). The clinical success rate was 94.1% (32/34). All stents were successfully removed. The mean procedural time from needle puncture to stent deployment was 10.3 ± 5.7 minutes. Four patients (11.8%) experienced procedure and/or stent-related AEs, including stent maldeployment (n = 1) and pseudocyst infection (n = 3). All patients completely recovered from the AEs. Bleeding caused by the stent or buried LAMS syndrome was not observed. No unplanned endoscopic procedures were required., Conclusions: This study showed that EUS-guided drainage using the newly designed LAMS is technically feasible and effective for the treatment of symptomatic pancreatic pseudocysts. (Clinical trial registration number: NCT02730663.)., (Copyright © 2019 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Although the efficacy of palliative bilateral biliary drainage using self-expandable metal stents has been demonstrated, it is unclear which bilateral method is optimal for advanced malignant hilar biliary strictures (MHSs). This pilot study compared bilateral stent-in-stent (SIS) with stent-by-stent (SBS) deployment for advanced MHSs., Methods: Patients with inoperable high-grade MHSs were enrolled in this prospective randomized multicenter study. The primary outcome was the rate of adverse events, whereas secondary outcomes were technical and clinical success, reintervention, therapeutic outcomes, stent patency, and survival duration., Results: This study randomized 69 of 74 pathologically diagnosed patients to the SIS (n = 34) or SBS (n = 35) groups. The total adverse event rate after stent deployment did not differ between the 2 groups (23.5% in the SIS group vs 28.6% in the SBS group, P = .633). The primary technical success rate was 100% (34/34) and 91.4% (32/35) in the SIS and SBS groups, respectively (P = .081). The clinical success rate was 94.1% (32/34) and 90.6% (29/32), respectively (P = .668). The stent patency rate at 3 months was 85.3% in the SIS group and 65.7% in the SBS group (P = .059). At 6 months, the stent patency rate was 47.1% and 31.4%, respectively (P = .184). The median cumulative stent patency and survival probability did not differ between the 2 groups., Conclusions: Efficacy of bilateral SIS and SBS deployment may be similar in terms of total adverse events, technical and clinical success, stent patency, and survival. The stent patency rates at 3 and 6 months was higher in the SIS group without statistical difference. (Clinical trial registration number: NCT01141088.)., (Copyright © 2019 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Backgrounds: Fully covered self-expandable metal stent (FCSEMS) are preferred for distal malignant biliary stricture (MBS). However, stent migration is a major adverse event of FCSEMS, especially for far distal MBS. We evaluated the usefulness of newly modified FCSEMS (M-FCSEMS) having 12 mm in diameter and anti-migration feature to minimize stent migration compared with the conventional FCSEMS (C-FCSEMS)., Methods: Total 102 patients were enrolled between January 2015 and September 2017 in this prospective comparative study; 50 were allocated to the M-FCSEMS group and 52 to the C-FCSEMS group. The primary outcome was stent migration, and the secondary outcomes were other adverse events, stent occlusion rate, and stent patency during the follow-up period., Results: The baseline characteristics of the two groups did not significantly differ. Endoscopic stent placement was technically successful in all patients. Stent migration occurred in 8.0% (4/50) of the patients in the M-FCSEMS group and 23.1% (12/52) of those in the C-FCSEMS group (P = 0.036). The other adverse events, including stent-related pancreatitis and cholecystitis did not significantly differ between the two groups (P = 0.415). Stent occlusion occurred in 23.9% (11/46) of the patients in the M-FCSEMS group and 37.5% (15/40) in the C-FCSEMS group (P = 0.171). Stent patency was significantly longer in the M-FCSEMS group than in the C-FCSEMS group (228 vs 157 days, P = 0.048)., Conclusions: Modified FCSEMS with 12-mm diameter and anti-migration feature significantly decreased the risk of stent migration and had longer patency compared with C-FCSEMS in patients with periampullary MBS., (© 2019 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.)

Background/aims: The covered self-expandable metal stent (CMS) was developed to prevent tumor ingrowth-induced stent occlusion during the treatment of malignant biliary obstruction. However, complications such as cholecystitis, pancreatitis, and stent migration can occur after the endoscopic insertion of CMSs. The aim of the present study was to assess the efficacy and safety of a double-layered CMS (DCMS) for the management of malignant bile duct obstruction., Methods: DCMSs were endoscopically introduced into 59 patients with unresectable malignant extrahepatic biliary obstruction at four tertiary referral centers, and the patient medical records were retrospectively reviewed., Results: Both the technical and functional success rates were 100%. Procedure-related complications including pancreatitis, cholangitis, stent migration, and liver abscess occurred in five patients (8.5%). The median follow-up period was 265 days (range, 31 to 752 days). Cumulative stent patency rates were 68.2% and 40.8% at 6 and 12 months, respectively. At the final follow-up, the rate of stent occlusion was 33.9% (20/59), and the median stent patency period was 276 days (range, 2 to 706 days)., Conclusions: The clinical outcomes of DCMSs were comparable to the outcomes previously reported for CMSs with respect to stent patency period and complication rates.

Background and Aims: Several EUS-specific stents have become available. It has been claimed that some of these stents have lumen-apposing properties, but objective data measuring such properties are not available. The aim of this study is to measure the lumen-apposing force (LAF) of these stents., Methods: The LAF of 3 EUS-specific metallic stents (stents A, N, and S) were compared in an ex vivo setting. Four types of anastomoses were performed with the stents including cholecysto-duodenal, cholecysto-gastric, gastro-gastric, and gastro-jejunal and compared with a hand-sewn (HS) equivalent of the anastomosis. The outcome parameter was the LAF created by each type of stent., Results: Sixty-four anastomoses were created. The overall mean (standard deviation) LAFs were significantly higher for stents A and S (P < .001). This difference persisted regardless of the type of anastomosis: gastro-gastric (P = .002), gastro-jejunal (P = .005), cholecysto-gastric (P = .002), and cholecysto-jejunal (P = .003). The differences in LAF created by each type of stent across different types of anastomoses were also compared. A trend to significance was observed in the anastomoses created by stent N (P = .064) and stent A (P =.052); a significant difference in LAF was observed among different anastomoses created by stent S (P = .015). The LAF created by HS anastomosis was significantly higher than that for all stents across all anastomoses., Conclusions: Stents A and S had a higher LAF. The use of these stents should be considered when performing EUS-guided transmural luminal anastomoses in non-adherent organs. Further studies are required to confirm the clinical efficacies of these EUS-specific stents., (Copyright © 2016 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: In patients with unresectable distal malignant biliary obstruction (MBO), endoscopic biliary drainage by using self-expandable metal stents (SEMSs) is an established palliative treatment. However, the placement of a SEMS across the major duodenal papilla prompts reflux of duodenal contents. In this study, we evaluated stent patency and duodenobiliary reflux caused by a newly developed SEMS with an antireflux valve (ARV) of the windsock type, compared with a conventional covered SEMS (cSEMS) in patients with MBO., Methods: Between January 2013 and September 2014, 77 patients with unresectable distal MBO were assigned randomly to groups treated with an ARV metal stent (ARVMS) group (39 patients) or a conventional cSEMS group (38 patients). In all patients, a barium meal examination was performed to evaluate reflux of barium within the SEMS and intrahepatic bile ducts. The primary outcome was stent patency duration. Secondary outcomes were the rates of technical and clinical success, duodenobiliary reflux on barium meal examination, factors causing stent dysfunction, overall patient survival, and adverse events., Results: Stent placement was technically successful in all patients. The clinical success rates were not statistically significantly different between the ARVMS and cSEMS groups (97.4% vs 97.4%, P = 1.000). Overall reflux of barium was significantly lower in the ARVMS group than the cSEMS group (7.7% vs 100%, P < .001). The cumulative duration of stent patency was significantly longer in the ARVMS group than in the cSEMS group (median ± SD, 407 ± 92 vs 220 ± 37 days; P = .013). On multivariate analysis, complete duodenobiliary reflux (odds ratio, 5.7, P = .004) and ampullary cancer (odds ratio, 8.98, P = .012) were identified as independent risk factors for stent dysfunction. There was no significant difference between the 2 groups in overall patient survival or in the incidence of adverse events., Conclusions: The newly developed ARVMS seemed to have a superior duration of stent patency and comparable safety compared with the cSEMS. In addition, the duodenobiliary reflux related to stent dysfunction can be prevented effectively by ARVMS. Further randomized, controlled trials using large numbers of subjects are required to confirm the benefit of SEMSs with antireflux function. (Clinical trial registration number: UMIN000012734.)., (Copyright © 2016 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Endoscopic management of unresectable hilar malignant biliary stricture (MBS) is currently challenging, and the best approach is still controversial. Liver volume is the key to adequate biliary drainage in hilar MBS and multiple stenting is mandatory to drain over 50% of liver volume in most cases. The self-expandable metallic stent (SEMS) has shown superior patency to plastic stents in recent reports. There are two methods of multiple stenting for hilar MBS: stent-in-stent (SIS) and side-by-side (SBS). Advantages of SIS include multiple SEMS placement in one stent caliber at the common bile duct (CBD), which is considered physiologically ideal. The through-the-mesh (TTM) technique with guidewires and the SEMS delivery system can be technically difficult in SIS, although the recent development of dedicated SEMSs having a loose portion facilitating the TTM technique makes SIS technically feasible both at stent deployment and re-interventions. Conversely, the SBS technique, if placed across the papilla, is technically simple at initial placement and re-intervention at stent occlusion. However, SBS has potential disadvantages of overexpansion of the CBD because of parallel placement of multiple SEMS, which can lead to portal vein thrombosis. Given the limited evidence available, a well-designed randomized controlled trial comparing these two techniques is warranted., (© 2015 Japanese Society of Hepato-Biliary-Pancreatic Surgery.)

Background: A lumen-apposing stent can be used effectively under endosonographic guidance., Objective: To evaluate a newly designed, fully covered self-expandable metal stent with folding anchoring flanges for lumen apposition assembled on a conventional delivery system., Design: Retrospective case series and animal study., Setting: Tertiary care academic medical centers., Subjects: Six pigs for animal study and 7 patients, 3 of whom underwent endoscopic drainage for acute cholecystitis (AC) and 4 for pancreatic fluid collection (PFC)., Intervention: Stent deployment under EUS guidance after puncturing, passage of an endoscope through the stent into the gallbladder (GB), or PFC with conventional endoscopic procedures., Main Outcome Measurements: Technical and clinical success, adverse events, and removability., Results: In the animal study, the stent was successfully inserted and deployed in the GB via a transgastric approach under EUS guidance without adverse events in all 6 pigs. Contrast injection demonstrated the absence of leakage. Cholecystoscopy with enhanced endoscopy was performed successfully in all animals after stent placement. All stents were intact and were removed successfully at 4 weeks. GB firmly adhered to the stomach with an intact cholecystogastric tract on necropsy and histopathology. The stents were successfully deployed without adverse effects in 7 patients. AC or PFC was resolved after stent placement in all patients. Endoscopic procedures were possible through the stent. Stent migration was not observed. The stent was successfully removed from the 4 patients with PFC after complete resolution., Limitations: Small sample size, retrospective study., Conclusions: Transenteric drainage and endoscopic intervention by using a novel fully covered self-expandable metal stent for lumen apposition under EUS guidance is feasible for the management of AC and PFC. Further study is warranted., (Copyright © 2014 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Surgical gastrojejunostomy is associated with relatively high morbidity and mortality rates. However, current experimental EUS-guided gastrojejunostomy information is limited., Objective: To evaluate a novel EUS-guided gastrojejunostomy technique using a new enteric balloon and lumen-apposing metal stent., Design: Animal experiment., Setting: Animal laboratory at a referral center., Subjects and Interventions: In 5 pigs, gastrojejunostomies were created under EUS guidance. Fully covered lumen-apposing stents were placed between the stomach and the jejunum., Main Outcome Measurements: Technical success and adverse events of EUS-guided gastrojejunostomy., Results: All stents, with 1 exception, were successfully deployed without any adverse events. The mean time to stent placement was 44.2 minutes (range 28-64 minutes). All animals showed normal eating behavior without signs of infection for 1 month after the procedure. Endoscopic imaging of the stomach site showed the stent to be patent and stable, without dislodgment, in all of the pigs. Necropsy showed complete adhesion between the stomach and the jejunum wall., Limitations: Pilot study., Conclusions: Creation of an EUS-guided gastrojejunostomy by using a novel enteric balloon and metal stent appears to be promising as a minimally invasive treatment., (Copyright © 2013 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Theoretically, the side-by-side bilateral placement of metal stents may be technically easier than stent-in-stent bilateral placement in stent revision. However, side-by-side placement can be technically challenging, as the deployment of the first stent can preclude the passage of the second stent., Aim: We explored the technical feasibility and revision efficacy of endoscopic bilateral side-by-side stent placement for malignant hilar biliary strictures., Methods: Forty-four patients with Bismuth type II or higher malignant hilar biliary strictures were enrolled in seven academic tertiary referral centers. Endoscopic placement of side-by-side bilateral metal stents with 7F thin delivery shaft was performed. The outcome measurements were the technical and functional success, adverse events, endoscopic revision success rate, and stent patency., Results: Overall, the technical and functional success rates were 91 % (40/44), and 98 % (39/40), respectively. Two of the failed patients were converted successfully with subsequent contralateral stent-in-stent placement, and the other patients underwent percutaneous intervention. Early stent-related adverse events occurred in 10 %. The endoscopic revision rate due to stent malfunction during follow-up (median: 180 days) was 45 % (18/40; tumor ingrowth in 4 and in-stent sludge impaction/stone formation in 14 patients). The endoscopic revision success rate was 92 % (12/13). Five patients with comorbidity underwent initial percutaneous intervention. The median survival and stent patency periods were 180 and 157 days, respectively., Conclusions: The sequential placement of a metal stent with a 7F thin delivery shaft in bilateral side-by-side procedures may be feasible and effective for malignant hilar biliary strictures and for endoscopic stent revision.

Objective: To report treatment outcomes and complications of uncovered self-expandable metallic stents (SEMS) as a first-line therapy for inoperable malignant duodenal obstructions in our hospital., Methods: A retrospective analysis was performed in patients who had undergone placement of uncovered SEMS as a first-line therapy for inoperable malignant duodenal obstruction from August 2001 to July 2011. Treatment outcomes and complications of the procedures were investigated., Results: In total, 47 patients (25 men; mean age 65 years) underwent the procedure. The technical and clinical success rates were 93.6% and 83.0%, respectively. Early complications occurred in 8 patients, including two guidewire-induced micro-perforations and six pancreatitis. All these 8 patients recovered with conservative treatment. Six late complications requiring additional procedures consisted of five stent occlusions due to tumor ingrowth and one stent migration. Four stent occlusions and one migration were treated by the placement of an additional covered stent and the remaining case was treated by balloon dilatation. The median primary stent patency period and median survival period after primary stent placement were 103 days and 131 days, respectively., Conclusions: Uncovered SEMS placement is effective as a first-line palliative therapy for inoperable malignant duodenal obstruction. Complications such as stent occlusion or migration can be easily managed with additional covered SEMS., (© 2012 The Authors. Journal of Digestive Diseases © 2012 Chinese Medical Association Shanghai Branch, Chinese Society of Gastroenterology, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine and Wiley Publishing Asia Pty Ltd.)

Background: Post-ERCP pancreatitis (PEP) is the most common and serious complication of ERCP. Difficult biliary cannulation can be a procedure-related risk factor for PEP. Recent studies reported that a prophylactic pancreatic stent (PS) can reduce the frequency and severity of PEP., Objective: To evaluate the efficacy and usefulness of a temporary 3F PS to prevent PEP in patients with difficult biliary cannulations., Design: A multicenter, prospective, randomized study., Setting: Two tertiary-care academic medical centers., Patients: In total, 101 patients with a difficult biliary cannulation were randomly divided into the 3F PS placement group (PS group, n = 50) or the nonstent (NS) group (NS group, n = 51)., Interventions: Endoscopic placement of a 3F unflanged PS., Main Outcome Measurements: The incidence and severity of PEP in the 2 groups, spontaneous dislodgment of stents, and procedure-related complications., Results: The technical success rate of 3F PS placement was 96% (48/50). The lengths of the stents were 4 cm (n = 21), 6 cm (n = 15), and 8 cm (n = 12). Spontaneous stent dislodgment within 7 days occurred in 94% of patients (45/48). The mean duration until spontaneous dislodgment was 3.5 days. The incidence rate of PEP was 12% (6/50: mild, 5; moderate, 1) in the PS group and 29.4% (15/51: mild, 12; moderate, 2; severe, 1) in the NS group. Severe pancreatitis occurred in only 1 patient in the NS group. In a multivariate analysis, prophylactic placement of PS was the only prophylactic factor for PEP (odds ratio, 0.126; 95% CI, 0.025-0.632, P = .012)., Limitations: No comparative results for stent size and diameter and a low-risk cohort group., Conclusions: Prophylactic temporary 3F PS placement in patients with a difficult biliary cannulation during ERCP seems to be a safe and effective method for reducing PEP and results in a high rate of spontaneous passage of stents without complications., (Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Endoscopic placement of fully covered self-expandable metal stents (FCSEMS) has been attempted to manage benign biliary strictures, but currently available FCSEMSs may be associated with unintended complications, including de novo strictures, in patients with normal life expectancy., Objective: To evaluate the feasibility of an intraductally placed modified FCSEMS to minimize stent-induced bile duct injury in patients with benign biliary strictures., Design: Prospective observational clinical feasibility study., Setting: Tertiary-care academic center., Patients: This study involved 21 patients with symptomatic benign biliary strictures in whom conventional endoscopic management failed., Intervention: Strictured segments were 15 mm above the ampulla of Vater. The modified FCSEMS has convex margins, a lasso, and an anti-migrating waist on the central portion. Stents were placed entirely above the papilla and removed after 3 to 5 months., Main Outcome Measurements: Success, complications, removability, midterm outcome., Results: FCSEMSs were successfully placed inside the bile duct in all patients. No episodes of pancreatitis, cholangitis, or sepsis were noted during the stenting period. Stent migration occurred in 4 patients (19.0%), but 3 were asymptomatic during follow-up. All stents were removed successfully with rat-tooth forceps without complications. Post-stenting cholangiograms showed improvement of strictures in 20 of 21 patients, without de novo focal stricture. The clinical success rate was 95.2%, with one recurrent stricture., Limitations: The small number and lack of comparison with other types of FCSEMSs., Conclusion: Temporary intraductal placement of a newly modified FCSEMS effectively improved strictures and prevented potential stent-induced complications in patients with benign biliary strictures. Controlled large-scale trials are needed to confirm the long-term efficacy., (Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Objectives: Fully covered self-expandable metal stents (FCSEMSs) can be effectively placed in patients with benign biliary stricture (BBS). However, stent migration is an inherent problem of FCSEMSs. We evaluated the efficacy of anchoring with a 5F double-pigtail plastic stent (anchoring stent) to prevent migration of an FCSEMS in patients with BBS., Methods: Between January 2007 and December 2009, 33 of 37 consecutive patients with BBS who had experienced treatment failure of at least one plastic stent placement were prospectively enrolled in this study. The patients with BBS were randomly assigned to undergo FCSEMS placement with or without an anchoring stent (anchoring group: 16 patients; non-anchoring group: 17 patients). The main outcome measures were the stent migration rate and success rates., Results: The technical success rate was 100% in both groups. Significantly less stent migration occurred in the anchoring group (6.3%, 1/16) than in the non-anchoring group (41.2%, 7/17; P=0.024). The median indwelling time was significantly longer in the anchoring group (154 days; range, 86-176 days) than in the non-anchoring group (114 days; range, 19-162 days; P=0.010). Improvement or resolution of the BBS was confirmed in 15 of 16 patients (93.8%) in the anchoring group, and in 12 of 17 patients (70.6%) in the non-anchoring group (P=0.101)., Conclusions: The placement of an anchoring stent appears to be a simple and effective method of preventing premature migration of FCSEMSs in patients with BBS. Appropriately powered studies are needed to confirm this finding.

Background: Endoscopic metallic stenting is a safe, effective treatment for malignant biliary obstructions, but can be technically difficult when combined malignant biliary and duodenal obstructions exist. Available duodenal metallic stents feature a tight mesh unsuitable for transpapillary biliary stenting. We evaluated the feasibility and usefulness of new endoscopic procedures for endoscopic double-stent placement in managing such obstructions., Methods: The through-the-scope duodenal metallic stent has a central cross-wired, unfixed structure that allows insertion of the biliary stent through the mesh wall of a duodenal stent. Transpapillary endoscopic placement of a biliary stent was performed through the lumen of this duodenal stent. Endoscopic ultrasound (EUS)-guided biliary drainage was performed successfully through the duodenal bulb after puncturing with a 19G needle. Biliary metallic stenting through the choledochoduodenal tract and effective drainage were achieved., Conclusions: Use of a combined endoscopic biliary and duodenal stent inserted through the mesh of the new duodenal metallic stent is feasible and effective in managing the aforementioned obstructions. EUS-guided biliary metal stenting is a therapeutic option for endoscopic management when a failed transpapillary approach through the lumen of the duodenal stent occurs. The continued development of endoscopic procedures and devices should resolve issues associated with complicated strictures.

Background: Self-expandable metallic stents (SEMS) of varying designs and materials have been developed to reduce complications, but few comparative data are available with regard to the type of stent and the stent manufacturer. We analyzed the success rates and complication rates, according to stent type (uncovered vs. covered stent) and individual stent manufacturer, in malignant colorectal obstruction., Methods: From November 2001 to August 2008, 103 patients were retrospectively included in this study: four types of uncovered stents in 73 patients and two types of covered stents in 30 patients. The SEMS was inserted into the obstructive site by using the through-the-scope method., Results: Technical and clinical success rates were not different between stent type or among stent manufacturers: 100 and 100% (p = ns) and 100 and 96.6% (p > 0.05), respectively, in uncovered and covered stents. Stent occlusion and migration rates were 12.3 and 3.3% (p = 0.274) and 13.7 and 16.7% (p = 0.761), respectively, in uncovered and covered stents, and 11.1, 5, and 9% (p = 0.761) and 25.9, 15, and 0% (p = 0.037) in Wallstent, Niti-S, and Bonastent uncovered stents, respectively., Conclusions: The placement of SEMS is an effective and safe treatment for patients with malignant colorectal obstruction. Although minor differences in outcome were detected according to the type and the manufacturer of the stents, no statistically significant difference was observed, except in stent migration among the stent manufacturer.

Small bowel adenocarcinoma is a relatively rare malignancy. In Korea, 13.1% of small bowel adenocarcinoma occurs in the jejunum. The absence of effective screening methods and relatively obscure symptoms contribute to the higher percentage of advanced cases at the time of diagnosis. Although curative resection is the mainstay of treatment, it is often impossible. Chemotherapy and radiotherapy have shown a disappointing treatment result for advanced staged small bowel adenocarcinoma. We report a 54-year-old woman with locally invasive jejunal cancer who underwent curative resection after stent insertion with enteroscopy and chemotherapy.

Background: Self-expandable metal stents (SEMSs) are an effective palliative treatment for malignant biliary or duodenal strictures, but endoscopic stenting for combined malignant biliary and duodenal obstruction remains technically difficult., Objective: To evaluate the feasibility and clinical success rate of endoscopic double stent-in-stent placement by using a new duodenal metallic stent for the management of malignant biliary and duodenal obstructions., Design: Prospective, observational clinical feasibility study., Setting: Tertiary referral center., Main Outcome Measurement: Technical and clinical success, complications, midterm outcome., Patients and Methods: Eight patients with inoperable malignant biliary and duodenal strictures were enrolled. Endoscopic placement of a biliary SEMS was performed through the mesh of the duodenal stent., Results: The duodenal strictures were in the first part of the duodenum in 3 patients (type 1) and in the second part in 5 patients (type 2). Duodenal stents were successfully deployed in all patients. Endoscopic placement of a biliary SEMS through the mesh of the duodenal stent was successful in 7 (87.5%) of 8 patients. In 2 of 3 patients with type 2 duodenal strictures with failed bile duct cannulation, biliary stenting was successful by using the rendezvous procedure. Early complications occurred in 1 patient. The overall median survival after combined stenting was 91 days (range 36-314 days)., Limitations: Small number of patients and no comparison with other enteral stents., Conclusions: Biliary stenting through the new duodenal metallic stent is technically feasible and has a high success rate. Combined endoscopic biliary and duodenal stent-in-stent placement is a promising solution for the palliation of malignant biliary and duodenal obstruction.

Objectives: For frail, elderly patients with large impacted common bile duct (CBD) stones, long-term treatment with biliary stenting provides palliation. Biliary stenting with choleretic agents such as ursodeoxycholic acid (UDCA) and terpene preparations may promote CBD stone size reduction. We studied the effectiveness of biliary stenting combined with UDCA and a terpene preparation as a medical treatment for difficult-to-remove CBD stones in patients older than 65 years in this multicenter, prospective study., Methods: A total of 28 elderly patients with CBD stones refractory to conventional endoscopic removal, including mechanical lithotripsy, underwent endoscopic placement of a straight 10-F plastic biliary stent. Each patient was administered 600 mg of UDCA and 300 mg of a terpene preparation daily for a mean of 6 months. After 6 months of medication following the initial endoscopic retrograde cholangiopancreatography (ERCP), a second ERCP was performed and endoscopic stone removal was again attempted. Differences in stone size and CBD diameter before and after biliary stenting and medication were compared. The complete stone removal rate after treatment was obtained., Results: The mean size (transverse x longitudinal diameter) of the CBD stones was initially 21.6 x 29.5 mm, and it decreased significantly to 12.2 x 20.1 mm at the second ERCP (P<0.01). The mean CBD diameter measured initially at the cystic duct insertion level was 23.2 mm, and it decreased significantly to 19.5 mm at the second ERCP (P<0.01). After biliary stenting with medication, endoscopic stone removal was successful in 26 of 28 patients (92.8%), with a mean of 1.7 subsequent ERCP sessions., Conclusions: Endoscopic biliary stenting with a period of combined UDCA and terpene preparation administration seems to be a safe and effective method for retained CBD stones in elderly patients. A prospective study with randomization and a control group is required to confirm these results.

Background: Endoscopic management of malignant hilar biliary strictures is difficult even for an experienced endoscopist. Moreover, endoscopic placement of bilateral metal stents is considered very difficult and complicated., Objective: We explored the feasibility and efficacy of the placement of a newly designed metal stent for an endoscopic bilateral stent-in-stent procedure for the management of malignant hilar biliary strictures., Design: Multicenter prospective feasibility study., Setting: Five academic tertiary referral centers., Patients: Thirty-five patients with malignant hilar biliary strictures of Bismuth type II or higher were enrolled., Interventions: Bilateral stent placement by an endoscopic stent-in-stent procedure., Main Outcome Measurements: Technical success, functional success, early and late complications, stent patency., Results: The overall technical success rate of the newly designed metal stent was 94.3% (33/35). The success rate of the stent-in-stent procedure in a single session was 82% (27/33) per protocol and 77% (27/35) as intent to treat. In cases in which the initial stent-in-stent procedure failed, patients underwent the endoscopic stent-in-stent procedure for contralateral stent placement at 2 days (6%, 2/33) or 4 days (12%, 4/33) after the initial stent placement. There was no percutaneous insertion of a contralateral stent in these patients. There was no stent-related early or late complication in any enrolled patient. Functional success was 100% (33/33). Reintervention because of stent malfunction was 6% (2/33). These 2 patients showed sludge formation in the stent. During follow-up, there was no stent tumor ingrowth or overgrowth in the placed stent in any enrolled patient. According to the Kaplan-Meier analysis, median survival and stent patency were 180 days and 150 days, respectively., Limitations: An uncontrolled feasibility study with a small patient population and a limited follow-up period., Conclusion: The newly designed metal stent for the endoscopic bilateral stent-in-stent procedure may be feasible and effective for malignant hilar biliary strictures.

Background/aims: Endoscopic stent insertion with self expandable metal stent (SEMS) is one of the standard palliative treatments for the patients with unresectable bile duct carcinoma. The aim of this study was to determine whether detection of longitudinal spread of extrahepatic bile duct carcinoma by intraductal US (IDUS) would be helpful in the selection of metal stent for the palliative drainage in bile duct carcinoma., Methods: Seventeen patients with histologically proven unresectable extrahepatic bile duct carcinoma who underwent endoscopic retrograde cholangiography with IDUS were included. Longitudinal cancer extension along the bile duct was determined and, then, compared with the cholangiographic image. The type and length of SEMS was selected based on IDUS findings., Results: IDUS demonstrated more extensive tumor spread than ERC in 7 of 17 (41.2%) patients with the hepatic side of strictures and in 7 of 16 (43.8%) patients with the duodenal side of strictures. Five of 17 (29.4%) patients have changed the plan of endoscopic biliary drainage with SEMS after IDUS. There was no early dysfunction associated with endoscopic biliary drainage., Conclusions: IDUS prior to biliary drainage would be useful in demonstrating longitudinal extension of extrahepatic bile duct carcinoma. It has a potential role in helping stent selection and identifying factors which predict early stent dysfunction.

Several cases of recurrent stone formation caused by a surgical material as a nidus have been reported. Recently, we experienced one case in which a migrated metal stent might have been served as a nidus for common duct stone formation. The diagnosis was confirmed by ERCP, the stone was successfully removed with endoscopic therapy. Six years ago, she had undergone a lithotripsy using a percutaneous cholangioscopy (PTCS) because of intrahepatic bile duct stones. Six years later, she developed abdominal pain in the right upper quadrant. ERCP revealed the dilated extrahepatic bile duct and left intrahepatic bile duct and the presence of a large elongated freely mobile filling defect suggestive of common bile duct stone containing metal mesh in the distal common bile duct. The removed stone with endoscopic sphincterotomy was soft and dark brown in color with metal stent.

Distal biliary strictures (DBS) are common and may be caused by both malignant and benign pathologies. While endoscopic procedures play a major role in their management, a comprehensive review of the subject is still lacking. Our consensus statements were formulated by a group of expert Asian pancreatico‐biliary interventional endoscopists, following a proposal from the Digestive Endoscopy Society of Taiwan, the Thai Association for Gastrointestinal Endoscopy, and the Tokyo Conference of Asian Pancreato‐biliary Interventional Endoscopy. Based on a literature review utilizing Medline, Cochrane library, and Embase databases, a total of 19 consensus statements on DBS were made on diagnosis, endoscopic drainage, benign biliary stricture, malignant biliary stricture, and management of recurrent biliary obstruction and other complications. Our consensus statements provide comprehensive guidance for the endoscopic management of DBS. [ABSTRACT FROM AUTHOR]