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Background: Benign choledochojejunal anastomotic stricture (CJS) is a common complication of pancreaticoduodenectomy and choledochojejunostomy. CJS is generally treated with balloon dilation, using balloon endoscopy-assisted endoscopic retrograde cholangiopancreatography (BE-ERCP); however, its long- and short-term outcomes have not been fully evaluated. Therefore, we evaluated the treatment outcomes of balloon dilation with BE-ERCP for CJS. Methods: We retrospectively analyzed 40 patients who had undergone balloon dilation with BE-ERCP for CJS between January 2009 and December 2022. The primary outcomes were technical and clinical success, and adverse event rates of balloon dilation using BE-ERCP for CJS. The secondary outcomes were long-term treatment outcomes for CJS recurrence, and evaluation of risk factors for recurrence. Result: Technical and clinical success rates were 93% (37/40) and 100% (37/37), respectively. CJS recurrence occurred in 32% (20/37). No procedure-related adverse events were observed. The significant risk factors of CJS after balloon dilation were its early occurrence after surgery (unit hazard ratio [HR] for month, 0.87; 95% confidence interval [CI], 0.76–0.99; p-value = 0.04) and residual waist during balloon dilation (HR, 5.46; 95% CI, 1.18–25.1; p-value = 0.03). Receiver operating characteristic curve analysis of time from surgery to balloon dilation revealed an area under the curve of 0.80 (95% CI, 0.65–0.94) and the cut-off value was 13.2 months. Conclusion: Treatment of CJS with balloon dilation was effective, although CJS recurrence occurred in one-third of the patients. The risk factors for recurrence were early occurrence of CJS after surgery and remaining waist circumference during balloon dilation. [ABSTRACT FROM AUTHOR]

Simple Summary: Collecting specimens for pathological diagnosis of malignant biliary stricture (MBS) is not easy. This study shows that cell block (CB) of overnight-stored bile is useful for pathological diagnosis of MBS. Cancer detectability using the CB method (62.2%) is superior to that using cytology (37.8%). When the CB method is combined with biopsy, the cancer detectability (75.6%) and accuracy rates (81.4%) are increased. In addition, immunohistochemistry can be applied to the CB method when encountering difficult cases for pathological diagnosis. The CB method utilizing overnight-stored bile can be routinely used for detecting MBS in local hospitals. The specimen collection and subsequent pathological diagnosis of malignant biliary stricture (MBS) are difficult. This study aimed to determine whether the cell block (CB) method using overnight-stored bile is useful in the diagnosis of MBS. This trial was a single-arm prospective study involving a total of 59 patients with suspected MBS. The primary endpoint was cancer detectability and accuracy using the CB method, and a comparison with the detectability and accuracy achieved with bile cytology was made. The immunohistochemical sensitivity for maspin and p53 was also investigated in the CB and surgical specimens. We were able to collect bile from all 59 patients, and 45 of these patients were clinically diagnosed with MBS. The cancer detectability using the CB method (62.2%) was significantly higher than that using cytology (37.8%) (p = 0.0344). When CB was combined with biopsy, the rates of cancer detectability (75.6%) and accuracy (81.4%) increased. In eight patients who received surgical therapy, maspin- and p53-immunohistochemistry was applied to the surgical and CB specimens, and cancer cells in both specimens showed positive cytoplasmic and nuclear staining for maspin and nuclear staining for p53. The CB method is, thus, useful for detecting malignancy (UMIN000034707). [ABSTRACT FROM AUTHOR]

BACKGROUND : Endoscopic papillary large balloon dilation (EPLBD) has been increasingly used for the management of large common bile duct (CBD) stones. Although EPLBD is often preceded by endoscopic sphincterotomy (EST), EPLBD alone without EST has been increasingly reported as an alternative to EST for large CBD stones. METHODS : This multicenter randomized trial was conducted at 19 Japanese institutions to compare the efficacy and safety of EPLBD alone versus EST for the removal of large (≥ 10 mm) CBD stones. The primary end point was complete stone removal in a single session. The secondary end points included: overall complete stone removal, lithotripsy use, procedure time, adverse events, and cost. RESULTS:  171 patients with large CBD stones were included in the analysis. The rate of single-session complete stone removal was significantly higher in the EPLBD-alone group than in the EST group (90.7 % vs. 78.8 %; P = 0.04). Lithotripsy use was significantly less frequent in the EPLBD group than in the EST group (30.2 % vs. 48.2 %; P = 0.02). The rates of early adverse events were comparable between the two groups: rates of overall adverse events were 9.3 % vs. 9.4 % and of pancreatitis were 4.7 % vs. 5.9 % in the EPLBD and EST groups, respectively. The procedure costs were $1442 vs. $1661 in the EPLBD and EST groups, respectively (P = 0.12). CONCLUSION : EPLBD without EST for the endoscopic treatment of large CBD stones achieved a significantly higher rate of complete stone removal in a single session compared with EST, without increasing adverse events. [ABSTRACT FROM AUTHOR]

Background and Aim: An antireflux metal stent (ARMS) for nonresectable distal malignant biliary obstruction (MBO) may prevent recurrent biliary obstruction (RBO) as a result of duodenobiliary reflux and prolong time to RBO (TRBO). Superiority of ARMS over conventional covered self‐expandable metal stents (SEMS) has not been fully examined. Methods: We conducted a multicenter randomized controlled trial to examine whether TRBO of an ARMS with a funnel‐shaped valve was longer than that of a covered SEMS in SEMS‐naïve patients. We enrolled 104 patients (52 patients per arm) at 11 hospitals in Japan. Secondary outcomes included causes of RBO, adverse events, and patient survival. Results: TRBO did not differ significantly between the ARMS and covered SEMS groups (median, 251 vs 351 days, respectively; P = 0.11). RBO as a result of biliary sludge or food impaction was observed in 13% and 9.8% of patients who received an ARMS and covered SEMS, respectively (P = 0.83). ARMS was associated with a higher rate of stent migration compared with the covered SEMS (31% vs 12%, P = 0.038). Overall rates of adverse events were 20% and 18% in the ARMS and covered SEMS groups, respectively (P = 0.97). No significant between‐group difference in patient survival was observed (P = 0.26). Conclusions: The current ARMS was not associated with longer TRBO compared with the covered SEMS. Modifications including addition of an anti‐migration system are required to use the current ARMS as first‐line palliative treatment of distal MBO (UMIN‐CTR clinical trial registration number: UMIN000014784). [ABSTRACT FROM AUTHOR]

Background: Both fully covered (FC) and partially covered (PC) self-expandable metal stents (SEMSs) are now commercially available for distal malignant biliary obstruction (MBO). While FCSEMS can be easily removed at the time of re-interventions, it is theoretically prone to migration. However, few comparative data between FC and PC SEMSs have been reported.Aims: The aim of this study was to compare clinical outcomes of FCSEMS with those of PCSEMS.Methods: This was a multicenter, prospective study of FCSEMS for unresectable distal MBO with a historical control of PCSEMS, which was previously reported as the WATCH study. The primary outcome was recurrent biliary obstruction (RBO), and secondary outcomes were stent migration, stent removal, stent-related adverse events, and survival.Results: A total of 151 cases with unresectable distal MBO undergoing FCSEMS placement were enrolled and compared with a historical cohort of 141 cases undergoing PCSEMS placement. No significant differences were found in the rate of RBO (29 vs. 33%; P = 0.451), time to RBO (318 vs. 373 days; P = 0.382), and survival (229 vs. 196 days; P = 0.177) between FCSEMS and PCSEMS. The rate of stent migration also did not differ significantly between the two groups (14 vs. 8%; P = 0.113). The removal of FCSEMSs was successful in all 24 attempted cases (100%).Conclusions: FCSEMSs appeared comparable to PCSEMSs in terms of RBO without a significant increase in stent migration rate in patients with unresectable distal MBO.Clinical Trial Registration Number: UMIN000007131. [ABSTRACT FROM AUTHOR]

Background and Aim: Percutaneous transhepatic drainage is the most common method for non‐operative gallbladder drainage, but the technique does have several disadvantages because of its invasive nature and requirement for continuous drainage. To overcome these disadvantages, we developed a novel procedure, endoscopic gallbladder lavage followed by stent placement, carried out in a single endoscopic session. Our aim was to prospectively evaluate the efficacy and safety of this procedure in patients with acute cholecystitis. Methods: Patients diagnosed with moderate cholecystitis at four tertiary care centers were enrolled in this study. We initially placed a 5‐Fr tube to carry out gallbladder lavage. The tube was then cut to the optimal length and placed as a stent. Main outcomes were procedural and clinical success rates. Results: The procedure was attempted in 40 patients and was successful in 30 (75.0%). Minor adverse events occurred in two (5.0%) patients: perforation of the cystic duct by the guidewire in one patient and pancreatitis in the other. Among the 30 patients in whom the procedure was successfully done, clinical resolution was obtained in 29 (96.6%). Elective cholecystectomy was carried out in 37 patients (92.5%), with a median delay after drainage of 42 days (range, 12–138 days). There were no adverse events during the waiting period. Conclusions: Gallbladder rinsing followed by internal drainage using a 5‐Fr nasobiliary tube is considered an effective and safe alternative to other techniques, providing an acceptable success rate in patients with acute cholecystitis prior to elective surgery. Clinical trial information: http://www.umin.ac.jp/ctr/index.htm (ID: UMIN‐000009680). [ABSTRACT FROM AUTHOR]

Background: In Japan and Europe, a retrieval basket is generally used for endoscopic extraction of bile duct stones, while in the US, a retrieval balloon is mainly used. However, the efficacies of these two devices have not been previously compared. Therefore, the present multicenter, prospective, randomized study was performed to compare the efficacies of these two devices for endoscopic biliary stone extraction.Methods: This study was designed as a non-inferiority study in comparing a basket removal with a balloon removal. Six Japanese institutions participated in this study, which included 184 patients with bile duct stones <11 mm in diameter with no limitation in the number of stones. The stones were identified and measured during ERCP, after which the patients were randomly assigned to undergo endoscopic stone extraction using either a basket catheter or a balloon catheter. The primary end point was the rate of complete removals of stones within 10 min, and the secondary end point was the rate of procedure-related complications.Results: There were 91 patients in the basket group and 93 in the balloon group. The rate of successful stone extraction within 10 min was 81.3 % (74/91) in the basket group and 83.9 % (78/93) in the balloon group (p = 0.7000). The complication rate was 6.6 % in the basket group and 11.8 % in the balloon group (p = 0.3092). Complications included bleeding, pancreatitis, and cholangitis.Conclusions: Basket and balloon catheters showed similar efficacies for endoscopic biliary stone extraction when stone size is 11 mm or smaller. [ABSTRACT FROM AUTHOR]

Background and Aim Endoscopic retrograde cholangiography (ERCP) with biliary stenting for the treatment of unresectable malignant biliary obstruction (MBO) is challenging among patients with surgically altered anatomy. Endoscopic ultrasound-guided antegrade biliary stenting (EUS-ABS) was introduced as an alternative biliary drainage method, although it has not yet been well studied. In this single-center prospective pilot study, we aimed to evaluate the feasibility and safety of EUS-ABS for MBO in patients with surgically altered anatomy. Methods EUS-ABS for MBO was attempted in patients with surgically altered anatomy. In EUS-ABS, the bile duct in the left lobe was accessed from the intestine under EUS guidance, and a guidewire was placed. Thereafter, an uncovered metallic stent was deployed at the MBO through the fistula. All devices were then removed. Technical, clinical, and adverse event rates, as well as patient characteristics and procedure details, were evaluated. Results Twenty patients (10 women; median age, 69 years) were enrolled in the present study. Technical and clinical success rates of EUS-ABS were both 95% (19/20). In one patient, unsuccessful EUS-ABS as a result of failed visualization of the left lobe of the liver with EUS was salvaged with percutaneous biliary drainage. Rate of adverse events was 20% (4/20), including mild pancreatitis in three patients and mild fever in one patient, which were successfully managed conservatively. Conclusions EUS-ABS for MBO in patients with surgically altered anatomy was a feasible and safe procedure. Further large scale comparison studies are needed to confirm its efficacy (Clinical Trial Registration Number: UMIN000008589). [ABSTRACT FROM AUTHOR]

Background and Aim In patients with unresectable malignant distal biliary obstruction, covered self-expandable metallic stents (CSEMS) may remain patent longer than uncovered self-expandable metallic stents as a result of tumor ingrowth prevention. One main cause of recurrent biliary obstruction (RBO) in CSEMS is sludge formation, which can be prevented using a large-bore stent. Therefore, we developed a novel, 12-mm diameter fully covered SEMS (FCSEMS) and investigated its clinical safety, efficacy, and rate of adverse events. Methods This prospective, multicenter pilot study, which ran between June 2011 and November 2012, included 38 consecutive patients with unresectable malignant distal biliary obstruction. All patients underwent endoscopic insertion of our novel stent. Primary endpoint was non-RBO rate 6 months after placement. Results Technical and functional success rates of the procedures were 100%. Six-month non-RBO rate was 50%, and median time to RBO was 184 days. Median survival time was 241 days. Twelve patients died within 6 months after stent placement without RBO. RBO was observed in 10 patients (26%), with seven experiencing stent occlusion and three experiencing stent migration. Adverse events other than RBO (at <30 days) developed in six patients (16%; cholecystitis, one; pancreatitis, one; hyperamylasemia, one; pancreatic ductitis, one; abdominal pain, two). Stent removal for reintervention was successfully completed in eight patients. Conclusion Our novel FCSEMS may be safe and effective for managing malignant distal obstruction with an acceptable incidence of adverse events. [ABSTRACT FROM AUTHOR]

Introduction: Endoscopic retrograde cholangiopancreatography in patients with surgically altered anatomy is challenging. Several endoscopic ultrasound (EUS)-guided biliary access techniques have been reported as effective alternatives. EUS-guided antegrade treatments (AG) have been developed more recently but have not yet been studied well. Aims: To evaluate the feasibility and safety of EUS-AG for biliary disorders in patients with surgically altered anatomies. Methods: We retrospectively identified all the patients who underwent EUS-AG. The left intrahepatic bile duct (IHBD) was initially punctured from the intestine followed by cholangiography, antegrade guidewire manipulation, and bougie dilation of the fistula. Either antegrade biliary stenting (ABS) or antegrade balloon dilation (ABD) was performed depending on the biliary disorders. In stone cases, the stones were antegradely pushed out using a balloon. After ABD, a nasobiliary drainage tube was placed to prevent possible bile leak and to keep an access route for any possible repeat procedures. Results: EUS-AG was attempted in seven patients including choledocholithiasis in five, malignant biliary obstruction in one, and bilioenteric anastomosis stricture in one. EUS-AG was not performed in one patient because EUS-cholangiography did not indicate the presence of stones. In the remaining six patients, the IHBD was successfully punctured, followed by cholangiography, guidewire insertion, and bougie dilation. ABS and ABD were successfully performed in one and five patients, respectively. Antegrade procedures with ABD were repeated twice in one patient. Mild complications were observed in two patients. Conclusions: EUS-AG for biliary disorders in patients with surgically altered anatomy is feasible. Further studies are warranted. [ABSTRACT FROM AUTHOR]

Introduction. Endoscopic retrograde cholangiopancreatography (ERCP) in patients with surgically altered upper gastrointestinal anatomy (SAA) is generally challenging despite the use of enteroscopy. After failed biliary cannulation, rendezvous technique (RV) can be an option to assist the biliary access. However, proper needle puncture of biliary ducts, which is critical in the RV procedure, can be difficult because of insufficient biliary dilation. By contrast, the gallbladder can be punctured as a possible access route for RV. Aim. To evaluate the feasibility and safety of percutaneous transgallbladder (PTGB)-RV in patients with SAA. Patients and methods. Six patients who underwent PTGB-RV were included. PTGB drainage was performed in cases without sufficient biliary duct dilation. A guidewire was inserted through the PTGB route with antegrade passage through the cystic duct, common bile duct and duodenal papilla. An enteroscope was inserted up to the papilla, at the guidewire exit site. The guidewire was pulled out through the accessory channel followed by biliary cannulation over the guidewire and endoscopic papillary balloon dilation (EPBD) for stone removal. Results. Six patients with SAA (Roux-en-Y in 4 and Billroth-II in 2) underwent PTGB-RV for removal of bile duct stones. In all patients, a guidewire was successfully inserted into the duodenum followed by insertion of the enteroscope and biliary cannulation. EPBD was then performed, but subsequent stone removal failed in 1 patient. Stone removal was successful in 5 patients without complication, except 1 case of mild pancreatitis. Conclusion. PTGB-RV seems to be a feasible and relatively safe salvage technique in patients with SAA. [ABSTRACT FROM AUTHOR]

Background and Aim: Currently, endoscopic intervention is widely attempted as the first-line treatment of benign biliary strictures because of its convenience and low morbidity. Plastic tube stents (PS) are usually used for such treatment; however, covered self-expandable metallic stents (C-SEMS) are becoming more commonly used at some institutions. The temporary placement of C-SEMS may lead to better outcomes because of their larger diameter and, therefore, better dilation of the stricture, especially in refractory cases. The aim of the present study was to evaluate the efficacy of the temporary placement of C-SEMS in the management of benign biliary strictures. Methods: We retrospectively reviewed our endoscopic retrograde cholangiopancreatography (ERCP) database (May 1996 to December 2010), and extracted the data of patients who underwent endoscopic treatment for benign biliary strictures. Then, the follow-up data from patient charts were reviewed to determine the long-term outcomes of those procedures. Results: All patients ( n = 56) initially had a PS placed, with or without balloon dilation. However, C-SEMS placement was later attempted in 12 patients because the stricture was refractory to placement of the PS. During their follow-up periods, two patients died of unrelated diseases after 15 and 17 months, and another two still had the C-SEMS in place after 9 and 50 months. In the remaining eight patients, the C-SEMS was removed after a median placement period of 6 months (range, 2-15). Seven patients in this group have not experienced a recurrence at a median follow-up time of 48 months. However, in one patient, stenosis did recur 8 months after the C-SEMS was removed. Conclusions: Temporary placement of C-SEMS can be a treatment option for benign biliary strictures, especially in refractory cases. [ABSTRACT FROM AUTHOR]

Background & Aims: Pancreatitis is the most common and potentially serious complication of post-endoscopic retrograde cholangiopancreatography (ERCP). Post-ERCP pancreatitis (PEP) is caused mostly by postprocedural papillary edema and retention of pancreatic juice. We conducted a randomized controlled trial to determine whether placement of a temporary-type, pancreatic duct stent prevents PEP and to identify risk factors for PEP. Methods: We analyzed data from 426 consecutive patients who underwent ERCP-related procedures at 37 endoscopic units. The patients were assigned randomly to groups that received stents (S group, n = 213) or did not (nS group, n = 213). The stent used was temporary, 5F in diameter, 3 cm long, and straight with an unflanged inner end. Results: The overall frequency of PEP was 11.3%. The frequencies of PEP in the S and nS groups were 7.9% and 15.2%, respectively; the lower incidence of PEP in the S group was statistically significant based on the full analysis set (P = .021), although there was no statistically significant differences in an intention-to-treat analysis (P = .076). There were significant differences in PEP incidence between groups in multivariate analysis for the following risk factors: pancreatography first, nonplacement of a pancreatic duct stent after ERCP, procedure time of 30 minutes or more, sampling of pancreatic tissue by any method, intraductal ultrasonography, and difficulty of cannulation (≥15 min). Patients with more than 3 risk factors had a significantly greater incidence of pancreatitis. Conclusions: Placement of a pancreatic duct stent reduces the incidence of PEP. Several risk factors are associated with PEP. [ABSTRACT FROM AUTHOR]

Diagnosis of the upstream extent of extrahepatic bile duct cancer has been difficult via the transpapillary approach, due to the difficulty of obtaining a biopsy sample above the stricture. We developed a new biopsy technique that allows a sample to be taken above the stricture, and prospectively evaluated the new technique's utility. Twenty-four consecutive patients diagnosed as having possible extrahepatic bile duct cancer by endoscopic retrograde cholangiopancreatography and other imaging tests were included in the study. They initially underwent endoscopic placement of a nasobiliary drainage tube. After improvement of jaundice and cholangitis, the cholangiogram obtained via the tube was examined and transpapillary biopsy was performed using a double lumen catheter under fluoroscopic guidance. The biopsy sampling in the stricture was successful in all cases, and pathological diagnosis was confirmed in all cases. The success rate of the method of upstream diagnosis was also sufficient in cases in which stricture was located below the middle extrahepatic bile duct. However, it was relatively low in cases whose stricture was located in the upper extrahepatic bile duct. Biopsy sampling in the hepatic hilum was also difficult. The transpapillary biopsy technique is useful for determination of the upstream extent of extrahepatic bile duct cancer, especially in cases in which stricture is located in the lower extrahepatic bile duct. Compared to the percutaneous transhepatic approach, it is less invasive and can shorten the preoperative period. It was also seen to be relatively safe, easy and convenient. [ABSTRACT FROM AUTHOR]

(1) Background: Endoscopic management of hilar biliary obstruction is still challenging. Compared with unilateral drainage, bilateral drainage could preserve larger functional liver volume and potentially improve clinical outcomes. To evaluate the effectiveness of bilateral drainage, we conducted this multicenter randomized controlled study. (2) Methods: Patients with unresectable malignant hilar biliary obstruction were assigned to unilateral or bilateral group. At first, patients underwent endoscopic nasobiliary drainage (ENBD), and subsequently underwent self-expandable metallic stent (SEMS) deployment. Primary outcomes were the functional success rate of ENBD and time to recurrent biliary obstruction (TRBO) after SEMS deployment. (3) Results: During the study period, 38 and 39 patients were enrolled in the unilateral and bilateral groups. The functional success rate was similar in the uni- and bi-ENBD group (57% vs. 56%; p = 0.99), but the rate of additional drainage was higher in uni-ENBD group. Although TRBO and overall survival time after SEMS deployment were not different between the groups (p = 0.11 and 0.78, respectively), the incidence of early adverse events tended to be higher in the bi-SEMS group (5.3% vs. 28%; p = 0.11). (4) Conclusions: Our study failed to demonstrate the superiority of bilateral over unilateral biliary drainage in terms of functional success rate and TRBO. [ABSTRACT FROM AUTHOR]

The consensus‐based TOKYO criteria were proposed as a standardized reporting system for endoscopic transpapillary biliary drainage. The primary objective was to address issues arising from the inconsistent reporting of stent outcomes across studies, which has complicated the comparability and interpretation of study results. However, the original TOKYO criteria were not readily applicable to recent modalities of endoscopic biliary drainage such as biliary drainage based on endoscopic ultrasound or device‐assisted endoscopy. There are increasing opportunities for managing hilar biliary obstruction and benign biliary strictures through endoscopic drainage. Biliary ablation has been introduced to manage benign and malignant biliary strictures. In addition, the prolonged survival times of cancer patients have increased the importance of evaluating overall outcomes during the period requiring endoscopic biliary drainage rather than solely focusing on the patency of the initial stent. Recognizing these unmet needs, a committee has been established within the Japan Gastroenterological Endoscopy Society to revise the TOKYO criteria for current clinical practice. The revised criteria propose not only common reporting items for endoscopic biliary drainage overall, but also items specific to various conditions and interventions. The term “stent‐demanding time” has been defined to encompass the entire duration of endoscopic biliary drainage, during which the overall stent‐related outcomes are evaluated. The revised TOKYO criteria 2024 are expected to facilitate the design and reporting of clinical studies, providing a goal‐oriented approach to the evaluation of endoscopic biliary drainage. [ABSTRACT FROM AUTHOR]