TOKYO criteria 2024 for the assessment of clinical outcomes of endoscopic biliary drainage.

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.

Measurement of the anchoring force of covered self-expandable and lumen-apposing metal stents for interventional endoscopic ultrasonography.

OBJECTIVES: Interventional endoscopic ultrasonography is performed for various situations that require drainage, after which stent migration is the most severe adverse event. Several lumen-apposing metal stents (LAMS) and covered self-expandable metal stents (CSEMS) provide antimigration systems; however, their anchoring ability has not been studied well. Therefore, we measured and compared the anchoring force (ACF) of commercially available LAMS and CSEMS. METHODS: Anchoring force was measured for five types of LAMS (NAGI, SPAXUS, Plumber, and AXIOS 8 and 10 mm) and seven types of CSEMS (BCL, SHCL, BCG, BPD [four types of HANAROSTENT], HILZO, Niti-S [Spring Stopper], and Wallflex). We created a phantom model for inducing stent migration. It has a rotatable part as a curved fixture, and we measured ACF at angles between 0° and 40°. RESULTS: The mean ACF at 0° and 20° were NAGI 1.50, 1.84 N, SPAXUS 1.73, 1.72 N, Plumber 2.64, 2.03 N, and AXIOS 3.96, 3.61 N, respectively; and BCL 0.48, 0.53 N, Wallflex 0.53, 0.48 N, SHCL 0.64, 0.73 N, HILZO 1.09, 1.09 N, BCG 1.22, 1.20 N, BPD 1.78, 1.67 N, and Spring Stopper 2.29, 2.51 N. CONCLUSION: We measured ACF in LAMS and CSEMS with a new phantom model. The highest value among the LAMS was for the AXIOS and among the CSEMS was for the Spring Stopper. Some of the ACF values varied with the direction of pull. These findings may have a significant impact on stent selection for interventional endoscopic ultrasonography, and this model can be used to evaluate newly developed stents.

Laparoscopic cholecystectomy after endoscopic trans-papillary gallbladder stenting for acute cholecystitis: a pilot study of surgical feasibility.

BACKGROUND: Percutaneous transhepatic gallbladder drainage (PTGBD) is indicated for patients with acute cholecystitis (AC) who are not indicated for urgent surgery, but external tubes reduce quality of life (QOL) while waiting for elective surgery. The objective of the present study was to investigate the feasibility of laparoscopic cholecystectomy after endoscopic trans-papillary gallbladder stenting (ETGBS) comparing with after PTGBD. METHODS: Intraoperative and postoperative outcomes of patients with ETGBS and PTGBD were retrospectively compared. RESULTS: Eighteen ETGBS and ten PTGBD patients were compared. Differences in the duration of ETGBS and PTGBD [median 209 min (range 107-357) and median 161 min (range 130-273), respectively, P = 0.10], median blood loss [ETGBS 2 (range 2-180 ml) and PTGBD 24 (range 2-100 ml), P = 0.89], switch to laparotomy (ETGBS 11% and PTGBD 20%, P = 0.52), and median postoperative hospital stay [ETGBS 8 (range 4-24 days) and ETGBS 8 (range 4-16 days), P = 0.99]. Thickening of the cystic duct that occurred in 60% of the ETGBS patients and none of the PTGBD patients (P = 0.005) interfered with closure of the duct by clipping. No obstruction occurred in ETGBS patients. CONCLUSION: ETGBS did not make laparoscopic cholecystectomy less feasible than after PTGBD. This is a pilot study, and further investigations are needed to validate the results of the present study.

Endoscopic ultrasound-guided antegrade procedures for managing bile duct stones in patients with surgically altered anatomy: Comparison with double-balloon enteroscopy-assisted endoscopic retrograde cholangiography (with video).

BACKGROUND AND STUDY AIM: Management of bile duct stones (BDSs) in patients with surgically altered anatomies (SAAs) remains challenging. An endoscopic ultrasound-guided antegrade (EUS-AG) procedure and double-balloon enteroscopy-assisted endoscopic retrograde cholangiography (DB-ERC) have been used to remove BDSs from patients with SAAs. However, few comparative data have been reported. Therefore, we compared the efficacy and safety of the techniques. METHODS: This was a single-center retrospective study. Patients with SAA who underwent the EUS-AG procedure or DB-ERC to remove intra- or extra-BDSs between November 2010 and March 2020 were included. The primary outcome was the technical success rate, defined as stent insertion or stone removal during the initial session. The secondary outcomes were the procedure time, incidence of adverse events (AEs), and complete stone removal rate. RESULTS: Of the 54 patients enrolled, 23 underwent the EUS-AG procedure and 31 DB-ERC. The technical success rates of EUS-AG and DB-ERC were 87.0% and 64.5%, respectively (P = 0.11). The procedure time was significantly shorter in the EUS-AG group than in the DB-ERC group (51.9 ± 15.4 vs 72.6 ± 32.2 min; P = 0.01), and the early AE rates were 26.1% and 12.9%, respectively (P = 0.71). The complete stone removal rates in patients who underwent previous stone removal were 94.1% in the EUS-AG group and 85.7% in the DB-ERC group (P = 0.61). CONCLUSION: The EUS-AG afforded technical success and complete stone removal rates comparable with those of DB-ERC, but the former procedure was shorter. The AE rate was acceptable.

Dedicated Echoendoscope for Interventional Endoscopic Ultrasound: Comparison with a Conventional Echoendoscope.

Background/Objective: Interventional endoscopic ultrasound (I-EUS) is technically difficult and has risks of severe adverse events due to the scarcity of dedicated endoscopes and tools. A new EUS scope was developed for I-EUS and was modified to increase the puncture range, reduce the blind area, and overcome guidewire difficulties. We evaluated the usefulness and safety of a new EUS scope compared to a conventional EUS scope. Methods: All I-EUS procedures were performed at Juntendo University Hospital from April 2020 to April 2022. The primary outcomes included the procedure time and fluoroscopy time. The secondary outcomes included the technical success rate and the rates of procedure-related adverse events. Clinical data were retrospectively reviewed and statistically analyzed between the new and conventional EUS scopes. Results: In total, 143 procedures in 120 patients were analyzed. The procedure time was significantly shorter with the new EUS scope, but the fluoroscopy time was not different. Among the patients only undergoing EUS-guided biliary drainage (EUS-BD), 79 procedures in 74 patients were analyzed. Both the procedure time and fluoroscopy time were significantly shorter with the new EUS scope. Multivariate analysis revealed that a new EUS scope and use of covered metal stents could reduce the fluoroscopy time. The technical success rate and the adverse event rate were not significantly different between the total I-EUS and the EUS-BD only groups. However, the conventional scope showed stent deviation during stent placement, which did not happen with the new scope. Conclusions: The new EUS scope reduced procedure time for total I-EUS and fluoroscopy time for EUS-BD compared to a conventional EUS scope because of the improvement suitable for I-EUS.

Retrospective evaluation of slim fully covered self-expandable metallic stent for unresectable malignant hilar biliary obstruction.

BACKGROUND: There have been few reports of covered self-expandable metallic stent (SEMS) placement for malignant hilar-biliary obstruction (MHBO) because of risk of biliary branch obstruction. We studied feasibility and efficacy of 6-mm-diameter, slim, fully covered SEMS (SFCSEMS) in a relatively large cohort. METHODS: We retrospectively evaluated SFCSEMS in unresectable MHBO from December 2016 to September 2021 in Juntendo University Hospital. RESULTS: We enrolled consecutive 54 unresectable MHBO (18 bile duct, 11 gallbladder, eight pancreatic, two hepatocellular, and 15 metastatic cancer cases) including Bismuth-type II (n = 11), III (n = 17), and IV (n = 26), and placed two (n = 35) or three (n = 19) SFCSEMS. The technical and clinical success rate was 100% and 92.5%, respectively, with 76.3 min of mean procedure time. Recurrent biliary obstruction (RBO) was observed in 35.2% and the median cumulative time to RBO (TRBO) was 181 days. Other adverse events were 11.1% (four mild-pancreatitis, one segmental-cholangitis, and one cholecystitis). There were no failed cases of stent exchange and second SFCSEMS (n = 6) showed significantly lower RBO (16.7% vs. 81.8%, P = .0364) and longer TRBO (undefined vs 86 days; P = .0617) than plastic stent (n = 11). CONCLUSIONS: Endoscopic placement of SFCSEMS for unresectable MHBO was effective and feasible with low incidence of segmental cholangitis, and exchange strategy of SFCSEMS was promising.

A case of groove pancreatitis with duodenal stenosis successfully treated by endoscopic ultrasonography-guided pancreaticogastrostomy.

One of the reasons for groove pancreatitis is caused by the leakage of pancreatic juice into the space between the pancreatic head, descending duodenum, and common bile duct. Endoscopic drainage of Santorini's duct (SD) via the minor papilla is reportedly efficacious but can be difficult due to duodenal stenosis. We report Santorini's duct drainage using endoscopic ultrasonography-guided pancreaticogastrostomy (EUS-PGS) for a case of groove pancreatitis with gastric outlet obstruction. Gastric outlet obstruction was improved after 7 months of EUS-PGS with internal drainage through the Santorini's duct/minor papilla. EUS-PGS may be effective for treating groove pancreatitis with duodenal stenosis. This is the first report of groove pancreatitis with duodenal stenosis, the symptoms of which were improved by EUS-PGS.

Current Situation and Problems in Diagnosis of Early Chronic Pancreatitis.

OBJECTIVES: The Japan Pancreas Society introduced the concept of early chronic pancreatitis (ECP) in 2009, but its epidemiology remains unclear. This study investigated challenges in ECP diagnosis. METHODS: Early chronic pancreatitis was diagnosed in 4 cohorts between April 2019 and November 2021 using the Clinical Diagnostic Criteria for Chronic Pancreatitis 2019. These cohorts included patients with abdominal/back pain, abnormal pancreatic enzyme levels, ECP suspected due to other reasons, and those who underwent endoscopic ultrasonography for other diseases. RESULTS: A total of 2502 cases were analyzed and 150 (40 alcoholic and 110 nonalcoholic) cases with ECP findings on endoscopic ultrasonography were included. Early chronic pancreatitis was confirmed in 14 cases (9%), including 9 (22.5%) alcoholic and 5 (4.5%) nonalcoholic cases. Early chronic pancreatitis was confirmed in 15%, 0%, 2.2%, and 0.13% cases in the 4 cohorts, respectively. Early chronic pancreatitis was confirmed in 10 (48%) of the 21 (14%) cases with pancreatic pain. CONCLUSIONS: Early chronic pancreatitis diagnostic rate was low, particularly in nonalcoholic cases, but was slightly higher in cases with pancreatic pain. The diagnostic rate was highest in the abdominal/back pain group. Further studies are required to establish appropriate diagnostic criteria for ECP.

A pilot study of Spring Stopper Stents: Novel partially covered self-expandable metallic stents with anti-migration properties for EUS-guided hepaticogastrostomy.

Background and Objectives: EUS-guided hepaticogastrostomy (EUS-HGS) is an effective salvage procedure when conventional endoscopic transpapillary biliary drainage is difficult or fails. However, the risk of stent migration into the abdominal cavity has not been resolved completely. In this study, we evaluated a newly developed partially covered self-expandable metallic stent (PC-SEMS) that has a spring-like anchoring function on the gastric side. Methods: This retrospective pilot study took place at four referral centers in Japan between October 2019 and November 2020. We enrolled 37 cases consecutively who underwent EUS-HGS for unresectable malignant biliary obstruction. Results: The rates of technical and clinical success were 97.3% and 89.2%, respectively. Technical failures included one case in which the stent was dislocated during the removal of the delivery system, requiring additional EUS-HGS on another branch. Early adverse events (AEs) were observed in four patients (10.8%): two with mild peritonitis (5.4%) and one each (2.7%) with fever and bleeding. No late AEs were observed during the mean follow-up period of 5.1 months. All recurrent biliary obstructions (RBOs) were stent occlusions (29.7%). The median cumulative time to RBO was 7.1 months (95% confidence interval, 4.3 to not available). Although stent migration in which the stopper was in contact with the gastric wall on follow-up computed tomography was observed in six patients (16.2%), no migration was observed. Conclusions: The newly developed PC-SEMS is feasible and safe for the EUS-HGS procedure. The spring-like anchoring function on the gastric side is an effective anchor preventing migration.

Recent Advances in Pancreato-Biliary Endoscopic Intervention: How to Resolve Unmet Needs in Pancreato-Biliary Diseases Endoscopically.

Various procedures are available for pancreato-biliary (PB) endoscopic interventions [...].

A case of endoscopic minor duodenal papillectomy after pancreatic stent placement using an endoscopic ultrasonography-guided rendezvous method.

Video 1The duct was cannulated with a modified MTW catheter using the hitch-and-ride method. A duodenal flap of the 5F, 7-cm pancreatic plastic stent was cut with a surgical scalpel and tied to the duodenal edge of the stent with a 0.3-mm silk suture. The suture tied to the stent was ligated at the center. The sutured stent was inserted into the pancreatic duct above the minor duodenal papilla. The tumor and silk suture were held together by a 25-mm oval polypectomy snare and were resected. The suture tied to the pancreatic plastic stent was grasped by biopsy forceps and pulled into the duodenum.

Efficacy and Safety of Peroral Pancreatoscopy Through the Fistula Created by Endoscopic Ultrasound-Guided Pancreaticogastrostomy.

OBJECTIVES: Endoscopic ultrasound/endosonography-guided pancreaticogastrostomy (EUS-PGS) is a useful alternative when endoscopic retrograde pancreatography is difficult. Recently, many procedures, including peroral pancreatoscopy (POPS), have been performed through the mature fistula (MF) created by EUS-PGS. We evaluate the efficacy and safety of POPS to diagnose and treat pancreatic ductal stricture/pancreato-jejunal anastomotic stricture (PDS/PJAS) through the MF. METHODS: Twenty patients underwent EUS-PGS; 13 of these underwent POPS through the MF at Juntendo University Hospital. All patients were studied retrospectively in terms of technical and clinical success rates and adverse events (AEs). RESULTS: The technical and clinical success rates of EUS-PGS were 95% and 100%. The early and late AEs rates were 20% and 15%. The technical success rate of POPS was 100%, with one AE. Biopsy of PDS/PJAS under POPS guidance revealed recurrent/residual intrapapillary mucinous adenoma (3 patients) and benign fibrotic stricture (10 patients). In the latter patients, multiple plastic stents were placed to dilate PDS/PJAS. Four patients with improvement of PDS/PJAS were stent free, but the remaining patients were not yet. CONCLUSIONS: Endoscopic ultrasound/endosonography-guided pancreaticogastrostomy and various procedures (including POPS) performed through the MF are feasible and effective and can diagnose and treat PDS/PJAS with acceptable AEs rates.