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Competing Interests: The authors declare that they have no conflict of interest.

Background and Aims: EUS-guided hepaticogastrostomy (EUS-HGS) is a rescue procedure when ERCP fails. Peritonitis and recurrent biliary obstruction (RBO) are adverse events (AEs) associated with EUS-HGS. Antegrade stent placement across a malignant distal biliary obstruction (DBO) followed by EUS-HGS (EUS-HGAS) creates 2 biliary drainage routes, potentially reducing peritonitis and prolonging time to RBO (TRBO). We compared the outcomes of the 2 techniques., Methods: Data of consecutive patients with malignant DBO who underwent attempted EUS-HGS or EUS-HGAS across 5 institutions from January 2014 to December 2020 were retrospectively analyzed. A matched cohort of patients was obtained using 1-to-1 propensity score matching. The primary outcome was TRBO, and secondary outcomes were AEs except for RBO and overall survival., Results: Among 360 patients, 283 (176 and 107 in the HGS and HGAS groups, respectively) were eligible. The matched cohorts included 81 patients in each group. AEs developed in 10 (12.3%) and 15 (18.5%) patients (P = .38) in the HGS and HGAS groups, respectively. RBO occurred in 18 and 2 patients in the HGS and HGAS groups, respectively (P < .001). TRBO was significantly longer in the HGAS group (median, 194 days vs 716 days; hazard ratio, .050; 95% confidence interval, .0066-.37; P < .01). However, no significant differences occurred in overall survival between the groups (median, 97 days vs 112 days; hazard ratio, .97; 95% confidence interval, .66-1.4; P = .88)., Conclusions: EUS-HGAS extended TRBO compared with EUS-HGS, whereas AEs, except for RBO and overall survival, did not differ. The longer TRBO of EUS-HGAS could benefit patients with longer life expectancy., Competing Interests: Disclosure All authors disclosed no financial relationships., (Copyright © 2024 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background: To prevent stent migration during endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS), intra-scope channel release technique is important, but is unfamiliar to non-expert hands. The self-expandable metal stent (SEMS) is an additional factor to prevent stent migration. However, no comparative studies of laser-cut-type and braided-type during EUS-HGS have been reported. The aim of this study was to compare the distance between the intrahepatic bile duct and stomach wall after EUS-HGS among laser-cut-type and braided-type SEMS., Methods: To evaluate stent anchoring function, we measured the distance between the hepatic parenchyma and stomach wall before EUS-HGS, one day after EUS-HGS, and 7 days after EUS-HGS. Also, propensity score matching was performed to create a propensity score for using laser-cut-type group and braided-type group., Results: A total of 142 patients were enrolled in this study. Among them, 24 patients underwent EUS-HGS using a laser-cut-type SEMS, and 118 patients underwent EUS-HGS using a braided-type SEMS. EUS-HGS using the laser-cut-type SEMS was mainly performed by non-expert endoscopists (n = 21); EUS-HGS using braided-type SEMS was mainly performed by expert endoscopists (n = 98). The distance after 1 day was significantly shorter in the laser-cut-type group than that in the braided-type group [2.00 (1.70-3.75) vs. 6.90 (3.72-11.70) mm, P < 0.001]. In addition, this distance remained significantly shorter in the laser-cut-type group after 7 days. Although these results were similar after propensity score matching analysis, the distance between hepatic parenchyma and stomach after 7 days was increased by 4 mm compared with the distance after 1 day in the braided-type group. On the other hand, in the laser-cut-type group, the distance after 1 day and 7 days was almost the same., Conclusions: EUS-HGS using a laser-cut-type SEMS may be safe to prevent stent migration, even in non-expert hands., Competing Interests: Competing interest No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this article., (Copyright © 2023 First Affiliated Hospital, Zhejiang University School of Medicine in China. Published by Elsevier B.V. All rights reserved.)

Competing Interests: The authors declare that they have no conflict of interest.

Background: Although the SpyGlass Direct Visualization System can be clinically useful for diagnosing indeterminate biliary stricture, it employs SpyBite forceps, which typically obtain only a small amount of tissue and have a low sampling rate. An improved forceps biopsy device for SpyGlass DS has recently been released (SpyBite MAX). The aim of this prospective registration study was to assess the diagnostic yield and efficacy of histological biopsy tissue obtained with SpyBite MAX forceps compared with SpyBite forceps in patients with indeterminate biliary stricture., Methods: The primary outcome of the study was the diagnostic accuracy of biopsy specimens obtained by SpyBite MAX forceps. The secondary outcomes were tissue size, number of forceps biopsies, rate of obtaining adequate tissue, and adverse events in the SpyBite MAX forceps group compared with the SpyBite group., Results: Forceps biopsies using SpyBite MAX (n = 47) and SpyBite (n = 50) were performed successfully in all patients. The number of biopsies performed before visible core tissue was obtained was significantly lower in the SpyBite (mean, 1.5 ± 0.7) than in the SpyBite forceps group (mean, 2.3 ± 1.1 mm; P < .001). Tissue sample size was larger in the SpyBite MAX group (mean, 1.8 ± 1.6 mm 2 ) than in the SpyBite group (mean, 1.0 ± 0.9 mm 2 ; P = .004) but there was no significant difference in diagnostic accuracy., Conclusion: Improvements in dedicated forceps for biopsy in SpyGlass DS may contribute to improving the rates of adequate tissue and tissue sample size obtained, and to reducing the number of forceps biopsies required., (© 2022 Japanese Society of Hepato-Biliary-Pancreatic Surgery.)

Background and Aim: Bilateral stent deployment for malignant biliary obstruction (MHBO) can be achieved using side-by-side (SBS) or stent-in-stent (SIS) procedures. Compared with SBS techniques, the procedural steps of SIS are technically complex due to the necessity of introducing the delivery system into a contralateral biliary tract through the mesh of the SEMS. To overcome this issue, a novel uncovered SEMS, the HILZO Moving Cell Stent (MCS) has been released. The present study examined the technical feasibility of treating MHBO using bilateral deployment of this novel stent without dilating the mesh of the first stent to achieve insertion of the second stent within a single session, using a prospective, multicenter setting., Method: The primary outcome in the present study was the technical success rate. Technical success was defined as deployment of bilateral MCSs into two or more biliary tracts using SIS without a dilation device in a single-session., Results: A total of 27 patients with complications of MHBO were enrolled in this study. Bilateral SIS using two MCS was successfully performed in 23 patients without using dilation devices among 27 patients (initial technical success rate; 85.2%). Median time to recurrent biliary obstruction (TRBO) was 271 days. Stent dysfunction was observed in 12 patients (44.4%), and re-intervention was successfully performed in all patients without one patient who instead received best supportive care., Conclusions: The SIS technique using MCS without dilation of the mesh may be technically feasible and safe. In addition, this may be useful for re-intervention. Further comparative randomized trials are needed., (© 2021 Japanese Society of Hepato-Biliary-Pancreatic Surgery.)

EUS-guided biliary drainage (EUS-BD) has been indicated for benign biliary strictures. However, the intrahepatic bile duct is sometimes much narrower in benign biliary strictures. In this situation, puncture of the intrahepatic bile duct using a 19-G needle is sometimes challenging. Several reports have described attempts at EUS-BD using a 22-G needle, but fistula dilation with a 22-G needle is challenging because the 0.018-inch guidewire is not stiff enough to perform dilatation. Recently, a thin mechanical dilator has become available. After its insertion into the biliary tract, the 0.018-inch guidewire can be replaced with a 0.025-inch guidewire. We herein describe the technical procedure of EUS-guided hepaticogastrostomy using a 22-G needle with a thin mechanical dilator., (© 2021 Japanese Society of Hepato-Biliary-Pancreatic Surgery.)

Introduction: Endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) is a novel drainage option for patients with an inaccessible papilla. Although EUS-HGS has clinical benefits in patients for whom endoscopic retrograde cholangiopancreatography (ERCP) has failed, the rates of adverse events (AEs) associated with EUS-HGS, such as bile peritonitis and stent migration, are higher than for other procedures. The development of a dedicated system for EUS-HGS is therefore desirable to reduce the rate of AEs. We developed a dedicated system for EUS-HGS (HG01 system) which is composed of a 19-gauge needle, 0.025-inch guidewire, a thin delivery system for tract dilation, and an antimigration metal stent. This study is designed to evaluate the efficacy and safety of EUS-HGS using the HG01 system in malignant biliary obstruction., Methods/design: This is a single-arm multicenter prospective study involving 40 patients across six tertiary centers in Japan. Patients with an unresectable malignant biliary obstruction in whom biliary drainage with ERCP failed, is not possible, or is very difficult will be registered in the study. The primary endpoint is the clinical success rate. The secondary endpoints are the technical success rate, procedure-related AE rate, procedure time, procedure success rate using only the HG01 system, stent patency rate, re-intervention success rate, re-intervention method, survival rate, and distance of movement of the stent position., Discussion: We expect use of the HG01 system to reduce the rate of AEs during EUS-HGS, especially bile leakage and stent migration. If the efficacy and safety of EUS-HGS using the HG01 system is confirmed in the present study, it is likely to be considered the first-choice device for use during EUS-HGS., (Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.)

Competing Interests: The authors declare that they have no conflict of interest.

Background and Aim: Endoscopic ultrasound-guided biliary drainage (EUS-BD) can be carried out by two different approaches: choledochoduodenostomy (CDS) and hepaticogastrostomy (HGS). We compared the efficacy and safety of these approaches in malignant distal biliary obstruction (MDBO) patients using a prospective, randomized clinical trial., Methods: Patients with malignant distal biliary obstruction after failed endoscopic retrograde cholangiopancreatography were randomly selected for either CDS or HGS. The procedures were carried out at nine tertiary centers from September 2013 to March 2016. Primary endpoint was technical success rate, and the noninferiority of HGS to CDS was examined with a one-sided significance level of 5%, where the noninferiority margin was set at 15%. Secondary endpoints were clinical success, adverse events (AE), stent patency, survival time, and overall technical success including alternative EUS-BD procedures., Results: Forty-seven patients (HGS, 24; CDS, 23) were enrolled. Technical success rates were 87.5% and 82.6% in the HGS and CDS groups, respectively, where the lower limit of the 90% confidence interval of the risk difference was -12.2% (P = 0.0278). Clinical success rates were 100% and 94.7% in the HGS and CDS groups, respectively (P = 0.475). Overall AE rate, stent patency, and survival time did not differ between the groups. Overall technical success rates were 100% and 95.7% in the HGS and CDS groups, respectively (P = 0.983)., Conclusions: This study suggests that HGS is not inferior to CDS in terms of technical success. When one procedure is particularly challenging, readily switching to the other could increase technical success., (© 2019 Japan Gastroenterological Endoscopy Society.)

Background: Gastric cancer is sometimes complicated by obstructive jaundice. However, ERCP may be challenging in patients who have advanced gastric cancer, or recurrent gastric cancer after surgical resection that is complicated by obstructive jaundice. In such cases, percutaneous transhepatic biliary drainage (PTBD) is considered. Recently, EUS-guided biliary drainage (EUS-BD) has been developed. We conducted a retrospective study to compare the efficacy of EUS-BD and PTBD in patients with obstructive jaundice due to gastric cancer., Methods: Patients with gastric cancer complicated with obstructive jaundice who were contraindicated for standard ERCP were enrolled., Results: A total of 47 consecutive patients were enrolled during the study period. The technical success rates of PTBD and EUS-BD were 88.9% (16/18) and 96.7% (29/30), respectively (P = 0.64). The stent patency period, including patient death was equivalent between the two groups (EUS-BD vs. PTBD: 188.4 days vs. 200.9 days, P = 0.974). Time to stent dysfunction in the EUS-BD group (391.1 days) was not significantly different as compared to that in the PTBD group (398.1 days) (P = 0.78). Adverse events were relatively severe in the PTBD group., Conclusions: Given the relative severity of adverse events in the PTBD group, EUS-BD might be the procedure of choice for gastric cancer patients with contraindications by inability to perform ERCP., (Copyright © 2018 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background: Fully-covered, self-expandable metal stents (FCSEMS) have been deployed to treat symptomatic chronic pancreatitis (CP) complicated with main pancreatic duct (MPD) stricture. Although this strategy can be effective, it has the disadvantages of stent migration or stent-induced ductal change. Removal of an FCSEMS can also be challenging in the face of distal migration because of MPD stricture. Dumbbell-type FCSEMS have been developed to prevent stent-induced ductal changes and improve removability when treating benign biliary stricture. This stent might also confer clinical benefits upon patients with MPD stricture., Aims: The present pilot study aimed to determine the feasibility and safety of deploying dumbbell-type FCSEMS in patients with CP complicated by MPD stricture., Method: Stents were deployed in 22 patients with MPD stricture caused by CP and complicated by abdominal pain., Results: Strictures were located at the head (n = 19), body (n = 2), and head and tail (n = 1) of the MPD. Stents were deployed above the papilla in three patients. All stents were deployed for a median duration of 142 (range, 49-190) days and removed. The resolution of MPD strictures was confirmed by pancreatography in 19 (86.3%) patients. Two metal stents that spontaneously tore during removal from two patients had otherwise functioned normally. Only three patients developed recurrent MPD stricture during a median follow-up of 419 (range, 261-484) days.., Conclusions: Deployment of a dumbbell-type FCSEMS seems feasible for MPD stricture, and the rate of adverse events is acceptable.

Background and Aim: Endoscopic ultrasonography-guided hepaticogastrostomy (EUS-HGS) is often indicated for advanced stage patients. Therefore it is important to prevent adverse events associated with EUS-HGS procedures and obtain long stent patency. EUS-guided antegrade stenting (AS) has been developed as an advanced technique. Thus, to prevent adverse events and achieve long stent patency, EUS-AS combined with EUS-HGS (EUS-HGAS) has been reported. The aim of the present study was to evaluate the technical feasibility and efficacy of EUS-HGAS in a multicenter, prospective study., Methods: This prospective study was carried out at each hospital of the Therapeutic Endoscopic Ultrasound Group. Primary endpoint of this multicenter prospective study was stent patency of EUS-HGAS., Results: A total of 49 patients were enrolled. Technical success rate of EUS-HGS was 95.9% (47/49). EUS-AS failed in five patients because the guidewire could not be advanced into the intestine across the bile duct obstruction site. Therefore, EUS-HGAS was successfully carried out in 40 patients (technical success rate: 85.7%). Median overall survival was 114 days. Median stent patency including stent dysfunction and patient death was 114 days. In contrast, mean stent patency was 320 days. Adverse events were seen in 10.2% (5/49) of cases. Hyperamylasemia was seen in four patients, and bleeding was seen in one patient., Conclusions: The present study is the first to evaluate EUS-HGAS. EUS-HGAS has clinical benefit for obtaining long stent patency and avoiding adverse events, although the possibility of acute pancreatitis as a result of obstruction of the orifice of the pancreatic duct must be considered., (© 2017 Japan Gastroenterological Endoscopy Society.)

Background and Aim: The clinical impact of catheter-based radiofrequency ablation (RFA) under endoscopic retrograde cholangiopancreatography (ERCP) guidance has recently been reported; however, severe adverse events have also been noted. If tumor is not present in the biliary tract, severe adverse events such as perforation or bleeding as a result of vessel injury around the biliary tract may occur. In addition, the effectiveness of RFA may not be sufficient based solely on radiographic guidance. The aim of the present study was to evaluate the actual feasibility of intraductal RFA by peroral cholangioscope (POCS) evaluation before/after RFA., Methods: In this retrospective study carried out between July and September 2016, consecutive patients who underwent RFA for malignant biliary stricture and POCS evaluation before/after RFA were enrolled. Primary endpoint of this study was technical feasibility of RFA, which was evaluated by POCS. Secondary endpoints were rates and types of adverse event., Results: A total of 12 consecutive patients were retrospectively enrolled in this study. Stent placement using uncovered metal stents had been previously done in six patients before RFA. Tumor was seen in the biliary tract in all patients. RFA was technically successful in all patients, and clinical success was confirmed in all patients by POCS imaging. Adverse events were seen in only one patient. Median stent patency was 154 days., Conclusions: RFA for malignant biliary stricture may be safe. To confirm the feasibility and efficacy of RFA, additional cases, prospective studies, and a comparison study between with and without endobiliary RFA are needed., (© 2017 Japan Gastroenterological Endoscopy Society.)