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Objectives: Malignant double obstruction, defined as the simultaneous presence of biliary and gastric outlet obstruction, represents a challenging clinical scenario. Previous retrospective experiences have demonstrated shorter dysfunction-free survival (DyFS) of endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) versus EUS-hepaticogastrostomy (EUS-HGS) in this setting, but no prospective evidence is available., Methods: Twenty consecutive patients with malignant double obstruction, treated with EUS-gastroenterostomy (and EUS-guided biliary drainage, following a previously failed ERCP, were enrolled in a prospective observational study (ClinicalTrials.gov NCT04813055) comparing EUS-CDS versus EUS-HGS. Efficacy and safety were evaluated, with Biliary Dysfunctions as the primary outcome and DyFS using Kaplan-Meier estimates as a primary measure., Results: Twenty patients (75% with pancreatic cancer, 50% with metastatic disease) with EUS-gastroenterostomy were included (seven EUS-CDS and 13 EUS-HGS). No significant difference was detected at baseline. Technical success was 100% in both groups. EUS-CDS compared to EUS-HGS showed similar clinical success (100% vs. 92.3%, p = 0.5), a higher rate of post-procedural adverse events (42.9% vs. 7.7%, p = 0.067, mostly related to severe/fatal cholangitis in the EUS-CDS group) and a higher rate of biliary dysfunctions during follow-up (71.4% vs. 16.7%, p = 0.002).DyFS was significantly shorter in the EUS-CDS group (39 [15-62] vs. 268 [192-344] days, p = 0.0023), with a 30-days DyFS probability of 57.1% vs. 100% (hazard ratio = 7.8 [1.4-44.2])., Conclusions: In this prospective comparison of patients with malignant double obstruction undergoing EUS-gastroenterostomy, treating jaundice with EUS-CDS versus EUS-HGS resulted in a reduced probability of survival without biliary events and an increased risk of biliary dysfunctions (number needed to harm = 1.8), with detection of severe/fatal cholangitis., Competing Interests: Giuseppe Vanella reports lecture fees from Boston Scientific and travel grants from Euromedical. Michiel Bronswijk received grant support from Boston Scientific. Roy LJ van Wanrooij holds a consultancy agreement with Boston Scientific. Schalk van der Merwe has consultancy agreements with Cook Medical, Pentax, and Olympus and chairs the Boston Scientific board in Therapeutic Biliopancreatic Endoscopy and the Cook Medical board in Interventional endoscopy. All other authors declare no conflict of interest., (© 2024 The Author(s). DEN Open published by John Wiley & Sons Australia, Ltd on behalf of Japan Gastroenterological Endoscopy Society.)

Objectives: Endoscopic ultrasound-directed transgastric endoscopic retrograde cholangiopancreatography (ERCP; EDGE) is proposed as a less invasive alternative to laparoscopy-assisted ERCP. However, postponing ERCP for 1-2 weeks to reduce the risk of lumen-apposing metal stent (LAMS) migration may not be practical in urgent cases such as cholangitis, leading to increased procedural burden. This study aimed to assess the feasibility and safety of a single-session EDGE utilizing a dedicated over-the-scope fixation device., Methods: A retrospective analysis of prospectively collected data from three referral centers was performed, including consecutive single-session EDGE procedures with the Stentfix device, utilizing only 20 × 10 mm LAMS. The primary outcome was LAMS migration, and key secondary outcomes included adverse events and technical success., Results: Twenty patients (mean age 59 [standard deviation (SD) ± 11.3] years, 65.0% female) with a predominantly classic Roux-en-Y gastric bypass history (90.0%, mini-bypass 10.0%) underwent ERCP for indications such as common bile duct stones (60.0%), cholangitis (25.0%), or biliary pancreatitis (15.0%). No LAMS migration occurred, and technical success was achieved in 95.0%. Over a median follow-up of 102 days (interquartile range [IQR] 24.8-182), two adverse events were reported (10.0%), comprising postprocedural pain (grade I) and post-ERCP pancreatitis (grade II)., Conclusion: While acknowledging potential contributions from LAMS orientation and stent caliber, our data suggest that utilizing a dedicated over-the-scope stent fixation device may effectively prevent LAMS migration during single-session EDGE without the need for endoscopic suturing., (© 2024 Japan Gastroenterological Endoscopy Society.)

Objectives: A new short device for percutaneous endoscopic cholangioscopy was recently developed. However, feasibility and safety has not yet been evaluated. The aim of this study was to assess clinical success, technical success, and adverse events (AEs)., Methods: This observational multicenter retrospective study included all patients who underwent percutaneous cholangioscopy using a short cholangioscope between 2020 and 2022. The clinical success, defined as the complete duct clearance or obtaining at least one cholangioscopy-guided biopsy, was assessed. The histopathological accuracy, technical success, and the AE rate were also evaluated., Results: Fifty-one patients (60 ± 15 years, 45.1% male) were included. The majority of patients had altered anatomy (n = 40, 78.4%), and biliary stones (n = 34, 66.7%) was the commonest indication. The technique was predominantly wire-guided (n = 44, 86.3%) through a percutaneous sheath (n = 36, 70.6%) following a median interval of 8.5 days from percutaneous drainage. Cholangioscopy-guided electrohydraulic lithotripsy was performed in 29 cases (56.9%), combined with a retrieval basket in eight cases (27.6%). The clinical success was 96.6%, requiring a median of one session (range 1-3). Seventeen patients (33.3%) underwent cholangioscopy-guided biopsies. There were four (7.8%) cholangioscopy-related AEs (cholangitis and peritonitis). Overall, the technical success and AE rates were 100% and 19.6%, respectively, in a median follow-up of 7 months., Conclusion: Percutaneous endoscopic cholangioscopy with a new short device is effective and safe, requiring a low number of sessions to achieve duct clearance or accurate histopathological diagnosis., (© 2023 The Authors. Digestive Endoscopy published by John Wiley & Sons Australia, Ltd on behalf of Japan Gastroenterological Endoscopy Society.)

Endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) with lumen apposing metal stent is emerging both as a rescue strategy and a primary treatment for distal malignant biliary obstruction. The large-scale diffusion of the procedure and improved overall survival of patients with pancreatobiliary neoplasms is resulting in a growing population of long-term EUS-CDS lumen apposing metal stent carriers. Recent studies have reported a need for reintervention during follow-up as high as 55%, and the Leuven-Amsterdam-Milan Study Group classification has been developed, identifying five mechanisms of stent dysfunction and 11 possible rescue strategies aimed at restoring biliary drainage. This illustrated technical review aims to further dissect the recent classification through a comprehensive analysis of nine illustrative cases, offering insights into the pathophysiology underlying dysfunction and clinical reasoning behind rescue interventions, as well as technical considerations and practical tips and tricks. By exploring mechanisms of dysfunction, this review also assists clinicians in selecting the ideal candidates for EUS-CDS while identifying patients deemed high risk for dysfunction or clinical failure., (© 2023 The Authors. Digestive Endoscopy published by John Wiley & Sons Australia, Ltd on behalf of Japan Gastroenterological Endoscopy Society.)

Objectives: Long-term outcomes of endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) performed with lumen apposing metal stents (LAMS) have been poorly evaluated in small or retrospective series, leading to an underestimation of LAMS dysfunction., Methods: All consecutive EUS-CDS performed in three academic referral centers were included in prospectively maintained databases. Technical/clinical success, adverse events (AEs), and dysfunction during follow-up were retrospectively analyzed. Kaplan-Meier analysis was used to estimate dysfunction-free survival (DFS), with Cox proportional hazard regression to evaluate independent predictors of dysfunction., Results: Ninety-three patients were included (male 56%; mean age, 70 years [95% confidence interval (CI) 68-72]; pancreatic cancer 81%, metastatic disease 47%). In 67% of procedures, 6 mm LAMS were used. Technical and clinical success were achieved in 97.8% and 93.4% of patients, respectively, with AEs occurring in 9.7% (78% mild/moderate). Dysfunction occurred in 31.8% of patients after a mean of 166 days (95% CI 91-241), with an estimated 6 month and 12 month DFS of 75% and 52%, respectively; mean DFS of 394 (95% CI 307-482) days. Almost all dysfunctions (96%) were successfully managed by endoscopic reintervention. Duodenal invasion (hazard ratio 2.7 [95% CI 1.1-6.8]) was the only independent predictor of dysfunction., Conclusions: Endoscopic ultrasound-guided choledochoduodenostomy shows excellent initial efficacy and safety, although stent dysfunctions occurs frequently during long-term follow-up. Almost all stent dysfunctions can be managed successfully by endoscopic reinterventions. We propose a comprehensive classification of the different types of dysfunction that may be encountered and rescue procedures that may be employed under these circumstances. Duodenal invasion seems to increase the risk of developing EUS-CDS dysfunction, potentially representing a relative contraindication for this technique., (© 2022 The Authors. Digestive Endoscopy published by John Wiley & Sons Australia, Ltd on behalf of Japan Gastroenterological Endoscopy Society.)

Objectives: Both clinical experience and supporting data have improved drastically in the context of endoscopic ultrasound-guided gastrointestinal anastomosis (EUS-GIA). Where outcomes used to be questioned, focus has now moved towards performing comparative studies, optimizing technical approaches, improving patient selection, and developing well-defined treatment algorithms., Methods: The purpose of this review is to provide an overview of technical developments within EUS-GIA and to discuss the current status of EUS-GIA and future directions., Results: EUS-GIA techniques such as EUS-guided gastroenterostomy (EUS-GE), EUS-directed transgastric endoscopic retrograde cholangiopancreatography (ERCP) (EDGE) and EUS-guided treatment afferent loop syndrome have undergone further development, refining technical approaches, improving patient selection and subsequent outcomes. Retrospective evaluations of EUS-GE have shown similar safety when compared to enteral stenting, whilst attaining surgical range efficacy. Whereas, in patients with gastric bypass anatomy, EDGE seems less cumbersome and time consuming than enteroscopy-assisted ERCP, while preventing surgical morbidity associated with laparoscopy-assisted ERCP. Although less evidence is available on EUS-guided treatment of afferent loop syndrome, this technique has been associated with higher clinical success and fewer reinterventions and adverse events when compared to enteral stenting and percutaneous drainage, respectively. Several randomized studies are currently underway evaluating EUS-GE in malignant gastric outlet obstruction (GOO), whereas more prospective data are still required on EDGE and long-term fistula management., Conclusion: EUS-GIA has become a crucial alternative to established techniques, overcoming technical limitations and subsequently improving patient outcomes. Although we should focus on prospective confirmation of these results in the context of GOO and EDGE, the current evidence already allows for a prominent role for EUS-GIA in our everyday practice., (© 2022 Japan Gastroenterological Endoscopy Society.)

Objectives: Endoscopic ultrasound-guided digestive anastomosis (EUS-A) is a new alternative under evaluation in patients presenting with afferent limb syndrome (ALS) after Whipple surgery. The aim of the present study is to analyze the safety and effectiveness of EUS-A in ALS., Methods: This is an observational multicenter study. All patients ≥18 years old with previous Whipple surgery presenting with ALS who underwent an EUS-A using a lumen-apposing metal stent (LAMS) between 2015 and 2021 were included. The primary outcome was clinical success, defined as resolution of the ALS or ALS-related cholangitis. Furthermore, technical success, adverse event rate, and mortality were evaluated., Results: Forty-five patients (mean age: 65.5 ± 10.2 years; 44.4% male) were included. The most common underlying disease was pancreatic cancer (68.9%). EUS-A was performed at a median of 6 weeks after local tumor recurrence. The most common approach used was the direct/freehand technique (66.7%). Technical success was achieved in 95.6%, with no differences between large (≥15 mm) and small LAMS (97.4% vs. 100%, P = 0.664). Clinical success was retained in 91.1% of patients. A complementary treatment by dilation of the stent followed by endoscopic retrograde cholangiopancreatography through the LAMS was performed in three cases (6.7%). There were six recurrent episodes of cholangitis (14.6%) and two procedure-related adverse events (4.4%) after a median follow-up of 4 months. Twenty-six patients (57.8%) died during the follow-up due to disease progression., Conclusion: EUS-A is a safe and effective technique in the treatment of malignant ALS, achieving high clinical success with an acceptable recurrence rate., (© 2022 Japan Gastroenterological Endoscopy Society.)

Objectives: Combined biliary obstruction and gastric outlet obstruction (GOO) represent a challenging clinical scenario despite developments in therapeutic endoscopic ultrasonography (EUS) as GOO might impair EUS-guided biliary drainage. Little is known about the effectiveness of different therapeutic combinations used to treat double obstruction, especially regarding stent patency., Methods: All consecutive patients with double obstruction treated between 2016 and 2021 in three tertiary academic centres were eligible for inclusion. Five combinations involving enteral stenting (ES), EUS-guided gastroenterostomy (EUS-GE), hepaticogastrostomy (EUS-HGS), choledochoduodenostomy (EUS-CDS), and transpapillary biliary stenting (TPS) were evaluated for dysfunction during follow-up, either as proportions or dysfunction-free survival (DFS) using Kaplan-Meier estimates., Results: Ninety-three patients were included (male 46%; age 67 [interquartile range 60-76] years; pancreatic cancer 73%, metastatic 57%), resulting in 103 procedure combinations. Different combinations showed significantly different overall dysfunction rates ( p = 0.009), ranging from the null rate of EUS-GE+HG to the 18% rate of EUS-GE+TPS, 31% of EUS-GE+EUS-CD, 53% of ES+TPS and 83% of ES+EUS-CDS. Sub-analyses restricted to biliary dysfunction confirmed these trends. A multivariate Cox proportional-hazards regression of DFS, a stenosis distal to the papilla (HR 3.2 [1.5-6.9]) and ES+EUS-CDS (HR 5.6 [2-15.7]) independently predicted dysfunction., Conclusions: Despite a lack of statistical power per combination, this study introduces new associations beyond the increased risk of GOO recurrence with ES versus EUS-GE. EUS-CDS showed reduced effectiveness and frequent dysfunction in the context of GOO, especially when combined with ES. EUS-GE+HGS or EUS-GE+TPS in this setting might result in superior patency. These results suggest that a prospective evaluation of the optimal endoscopic approach to malignant double obstruction is needed., Competing Interests: Michiel Bronswijk has consultancy agreements with Taewoong/ Prion Medical, and reports travel grants from Taewoong, Norgine, and Prion Medical; Roy LJ van Wanrooij holds a consultancy agreement with Boston‐Scientific. Wim Laleman co‐chairs the Boston‐Scientific Chair in Therapeutic Biliopancreatic Endoscopy, and has consultancy agreements with Boston Scientific and Cook Medical. Hannah van Malenstein holds a consultancy agreement with Boston‐Scientific. Paul Fockens holds a consultancy agreement with Olympus and Cook Medical. Schalk van der Merwe co‐chairs the Boston‐Scientific Chair in Therapeutic Biliopancreatic Endoscopy, holds the Cook Medical chair in Portal Hypertension, and holds consultancy agreements with Boston Scientific, Cook Medical and Pentax. Rogier P Voermans reports a consultancy agreement and research grant from Boston‐Scientific. All other authors declare no conflict of interest., (© 2022 The Authors. DEN Open published by John Wiley & Sons Australia, Ltd on behalf of Japan Gastroenterological Endoscopy Society.)