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Introduction: Recently, a novel self-assembling peptide hemostatic gel has become available in Japan. However, the safety and efficacy of this novel self-assembling peptide hemostatic gel remain unclear for bleeding after EST. The aim of this study was to evaluate the safety and efficacy of a novel self-assembling peptide hemostatic gel for bleeding after EST, and to perform a comparison to a conventional endoscopic hemostasis technique. Method: This retrospective study was carried out between January 2019 and October 2022. Patients who developed bleeding associated with EST were enrolled. The patients were divided into two groups based on the hemostasis technique used: a conventional hemostasis technique (Group A) or a novel self-assembling peptide hemostatic gel hemostasis technique (Group B). Result: A total of 62 patients (Group A, n = 36; Group B, n = 26) were included. Endoscopic hemostasis was initially obtained in 72.2% (26/32) of patients in Group A and in 88.4% (23/26) of patients in Group B, which was not significantly different (p = 0.1320). However, the procedure time was significantly shorter in Group B (mean, 9.38 min) compared with Group A (mean, 15.4 min) (p = 0.0103). There were no significant differences in the severity of bleeding between the two groups (p = 0.4530). Post-EST bleeding was observed in six patients (Group A, n = 4; Group B, n = 2). Adverse events were more frequently observed in Group A (n = 12) than in Group B (n = 1) (p = 0.0457). Conclusions: PuraStat application for EST bleeding might be safe and effective, and is comparable to the conventional endoscopic hemostasis technique, although further prospective randomized trials are needed. [ABSTRACT FROM AUTHOR]

Background: After multiple uncovered self-expandable metal stent (UCSEMS) deployments, endoscopic revision becomes complex and potentially challenging. A novel stent delivery system with a dilation function has recently been developed in Japan. This study evaluated the technical feasibility of this device for patients with unresectable malignant hilar biliary obstruction (MHO) after multiple UCSEMS deployments. Method: Participants comprised consecutive patients with unresectable MHO who had undergone multiple UCSEMS deployments and required endoscopic revision for the right or left hepatic bile ducts, as decided by cholangiography under endoscopic retrograde cholangiopancreatography (ERCP) guidance. Results: A total of 14 patients requiring endoscopic revision of right and left hepatic bile ducts were enrolled in this study. Among these 14 patients, guidewire insertion through the mesh of previously placed stents failed in 2 patients. As a result, these two patients underwent only unilateral UCSEMS deployment. Because clinical success was not obtained, transmural placement of the UCSEMS under Endoscopic Ultrasound (EUS) guidance to the segment of the liver not being drained was performed in those patients. The molting technique was attempted in 12 patients, proving successful in all patients. The technical success rate was therefore 92.8% (12/14). Mean procedure time was 23.2 min. Conclusion: This novel stent delivery system with a dilation function may be useful in endoscopic revision techniques for bilateral UCSEMS deployment. [ABSTRACT FROM AUTHOR]

Recently, endoscopic ultrasound (EUS)‐guided biliary drainage has been developed as an alternative biliary drainage technique for failed endoscopic retrograde cholangiopancreatography (ERCP) or inaccessible papilla. Among the various EUS‐guided biliary drainage procedures, EUS‐guided hepaticogastrostomy (HGS) can be performed in patients with surgically altered anatomy. More recently, various transluminal treatments have been described after EUS‐HGS, such as antegrade stone removal. In patients with hepaticojejunostomy strictures, stone extraction into the intestine might be challenging even after performing hepaticojejunostomy stricture dilation using a balloon catheter. In such cases, transluminal stone removal is considered an alternative method. With transluminal stone removal, a small stone that escapes from the conventional basket or from a balloon catheter could migrate into the branch bile ducts. The novel spiral basket catheter available in Japan. The wires form a helix shape, wherein each wire is wound counterclockwise, and the winding pitch becomes gradually tighter from the proximal portion to the tip. As the winding pitch is smaller and the wires are in closer contact with the bile duct wall as compared with conventional basket catheter, small bile duct stones can be easily captured by simply pulling back the catheter while the basket is open. In addition, even during withdrawal inside the bile duct, a high retrieval performance is assured by the special design that maintains the opening width on the top end. Therefore, transluminal stone removal using this novel basket catheter might be clinically useful, although further prospective evaluation of a larger number of cases is needed. [ABSTRACT FROM AUTHOR]

Background: Endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) is a common technique for biliary drainage. However, EUS-CDS is associated with adverse events such as cystic duct obstruction, stent dislocation, and stent kinking caused by powerful axial force. A novel double-bare, covered self-expandable metal stent (DBSEMS) has recently become available in Japan. This pilot study evaluated the clinical outcomes of EUS-CDS using DBSEMS. Method: We retrospectively enrolled patients with malignant lower bile duct obstruction who underwent EUS-CDS due to failed endoscopic retrograde cholangiopancreatography (ERCP). EUS-CDS procedures performed between April 2017 and March 2018 used a conventional fully covered self-expandable metal stent (FCSEMS), and those performed between April 2018 and April 2019 used DBSEMS. In all stents, the diameter was 10 mm and length was 6 cm. Results: A total of 22 patients underwent EUS-CDS, performed using conventional FCSEMS (n = 12) and DBSEMS (n = 10). Four complications occurred with FCSEMS: cholangitis due to kinking (n = 3) and stent dislocation (n = 1). With DBSEMS, there were no instances of kinking, and reflux cholangitis that developed in 1 patient due to duodenal obstruction was resolved by duodenal stenting. Elapsed time to recurrent biliary obstruction was longer with DBSEMS than FCSEMS (200 vs. 99 days), although the difference was not significant (p = 0.06). Conclusion: BSEMS can help prevent cholangitis due to stent kinking after EUS-CDS, thus increasing stent patency. [ABSTRACT FROM AUTHOR]

Background: Recently, lumen-apposing metal stents (LAMS) have been developed as novel devices for not only endoscopic ultrasound (EUS)-guided pancreatic fluid drainage but also for EUS-guided gallbladder drainage (GBD). Although LAMS might be clinically impactful, these stents have not yet become available as EUS-GBD stents in all countries, including Japan. Instead, improved metal stents (NEO stents) have become available. The aim of this pilot study was to evaluate the feasibility and safety of EUS-GBD using the improved metal stent with an anti-stent migration system for acute cholecystitis (AC). Method: The gallbladder was punctured using a 19-G needle, and a 0.025-inch guidewire was inserted into the gallbladder. After fistula dilation, stent deployment was performed from the gallbladder to the duodenum. Finally, a plastic 7-Fr pigtail stent was placed to prevent stent migration. Result: EUS-GBD using NEO stents with the anti-stent migration system was attempted in 12 consecutive patients with AC as a complication of other conditions. EUS-GBD was successfully performed in all patients without any adverse events, and clinical success was achieved in all patients. Median procedure time was 19.0 min (range, 19–24 min). In 4 patients, stent removal was successfully performed after 3 months. Stent migration during follow-up (median, 189 days) was not seen in any of the patients. Conclusion: Although this study has several limitations such as small number of patients and short follow-up period, the results show that NEO stents might be suitable as EUS-GBD stents in selected patients. Our results should be validated by a larger prospective, randomized study. [ABSTRACT FROM AUTHOR]

Background: Endoscopic treatment for malignant biliary obstruction (MBO) in patients bearing surgically altered anatomy (SAA) is not well-established. Although endoscopic ultrasound-guided biliary drainage (EUS-BD) has emerged as a new treatment option for MBO, limited data are available regarding the efficacy and safety of EUS-BD in patients with SAA. We conducted a multicenter prospective registration study to evaluate the efficacy and safety of EUS-BD in this population. Methods: This study involved 10 referral centers in Japan. Patients with SAA who were scheduled to receive EUS-BD for unresectable MBO between May 2016 and September 2018 were prospectively registered. The primary endpoint was technical success and the secondary outcomes were clinical success, procedure time, procedure-related adverse events (AEs), stent patency, and overall survival. Results: In total, 40 patients were prospectively enrolled. The surgical reconstruction methods were gastrectomy with Roux-en-Y reconstruction (47.5%), gastrectomy with Billroth-II reconstruction (15%), pancreaticoduodenectomy (27.5%), and hepaticojejunostomy with Roux-en-Y reconstruction (10%). EUS-BD was performed for primary biliary drainage in 31 patients and for rescue biliary drainage in nine patients. Transmural stenting alone (60%), antegrade stenting alone (5%), and a combination of the two techniques (35%) were selected for patients treated with EUS-BD. Technical and clinical success rates were 100% (95% confidence interval, 91.2-100.0%) and 95% (95% confidence interval, 83.1-99.4%), respectively. Mean procedure time was 36.5 min. Early AEs were noted in six patients (15%): three self-limited bile leak, one bile peritonitis, and two pneumoperitonea. Late AEs occurred in six patients (15%): one jejunal ulcer and five stent occlusions. Stent patency rate after 3 months of survival was 95.7% (22/23). Median overall survival was 96 days. Conclusion: EUS-BD for MBO in patients with SAA appears to be effective and safe not only as a rescue drainage technique after failed endoscopic retrograde cholangiography but also as a primary drainage technique. Clinical Trial Registration: UMIN000022101 [ABSTRACT FROM AUTHOR]

Background: Patients with isolated IgG4-related sclerosing cholangitis (IgG4-SC) often undergo unnecessary resection. The aim of this study was to validate the revised Japanese diagnostic criteria for isolated IgG-4-SC and to improve awareness about this condition in the population., Methods: This was a Japanese retrospective multicenter study. We focused on the data and diagnostic yield obtained using the Japanese diagnostic criteria published initially in 2012 and revised later in 2020 for the diagnosis of isolated IgG4-SC., Results: Patients with isolated IgG4-SC could be classified into two groups based on the primary location of the lesion: the hilar type (n = 40) and the extrahepatic type (n = 13). In total, 10 patients with the hilar type had undergone unnecessary resection. The revised 2020 criteria are useful for the diagnosis of extrahepatic lesions, which are not included in the 2012 criteria. The need for a steroid trial was reduced from 37.7% when the diagnosis was based on the 2012 criteria to 7.6% when the diagnosis was based on the revised 2020 criteria. The diagnostic specificity also improved from 58.5% for the 2012 criteria to 88.7% for the revised 2020 criteria., Conclusion: Our validation of the 2020 criteria for the diagnosis of IgG4-SC could contribute to avoiding unnecessary resection in patients with isolated IgG4-SC, which can be classified into the hilar and extrahepatic types. The 2020 criteria can enhance the diagnosis rate of isolated IgG4-SC and uncover this tough-to-diagnose entity based on inclusion of the imaging findings and decrease the dependence on a steroid trial., (© 2024 Japanese Society of Hepato‐Biliary‐Pancreatic Surgery.)

Background: Endoscopic ultrasound (EUS)-guided transluminal drainage has become a first-line treatment modality for symptomatic pancreatic pseudocysts. Despite the increasing popularity of lumen-apposing metal stents (LAMSs), plastic stents may resolve non-necrotic fluid collections effectively with lower costs and no LAMS-specific adverse events. To date, there has been a paucity of data on the appropriate stent type in this setting. This trial aims to assess the non-inferiority of plastic stents to a LAMS for the initial EUS-guided drainage of pseudocysts., Methods: The WONDER-02 trial is a multicentre, open-label, non-inferiority, randomised controlled trial, which will enrol pancreatic pseudocyst patients requiring EUS-guided treatment in 26 centres in Japan. This trial plans to enrol 80 patients who will be randomised at a 1:1 ratio to receive either plastic stents or a LAMS (40 patients per arm). In the plastic stent group, EUS-guided drainage will be performed using two 7-Fr double pigtail stents. In the LAMS group, the treatment will be performed in the same way except for LAMS use. The step-up treatment will be performed via endoscopic and/or percutaneous procedures at the trial investigator's discretion. The primary endpoint is clinical success, which is defined as a decrease in a pseudocyst size to ≤ 2 cm and an improvement in inflammatory indicators (i.e. body temperature, white blood cell count, and serum C-reactive protein). Secondary endpoints include technical success, adverse events including mortality, pseudocyst recurrence, and medical costs., Discussion: The WONDER-02 trial will investigate the efficacy and safety of plastic stents compared to a LAMS in EUS-guided treatment of symptomatic pancreatic pseudocysts with a particular focus on the non-inferior efficacy of plastic stents. The findings will help establish a new treatment algorithm for this population., Trial Registration: ClinicalTrials.gov NCT06133023 registered on 9 November 2023. UMIN000052647 registered on 30 October 2023. jRCT1032230444 registered on 7 November 2023., (© 2024. The Author(s).)

Background: Self-expandable metal stents (SEMSs) are widely used in patients with distal malignant biliary obstruction. A SEMS that can avoid occlusion as much as possible is desirable., Aims: The aim of this multicenter single-arm prospective study was to assess the clinical effectiveness and safety of a novel fully covered braided SEMS., Methods: We enrolled consecutive patients with distal malignant biliary obstruction between February 2016 and November 2017 at ten tertiary-care medical centers., Results: We included 79 patients with a median age of 76 years; 47 (59.5%) patients were men. The technical and clinical success rate was 98.7% and 93.6%, respectively. Recurrent biliary obstruction occurred in 14 patients (17.9%); stent ingrowth, overgrowth, migration, and other occurred in five (6.4%), four (5.1%), four (5.1%), and one (1.3%) patients, respectively. All reinterventions in patients with recurrent biliary obstruction were successful via the transpapillary approach. Adverse events occurred in 15 patients (19.2%); cholangitis, pancreatitis, and others occurred in ten (12.8%), three (3.8%), and two (2.6%) patients, respectively. The stent patency probability at 6 months was 48.5%. Median time to stent patency was 171 days, median time to recurrent biliary obstruction was 536 days, and median survival time was 195 days., Conclusions: We confirmed the utility and safety of a novel fully covered braided SEMS with low axial force and high radial force in patients with malignance biliary obstruction. This novel SEMS is recommended in patients with distal malignant biliary obstruction.

Background: Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) was developed with the aim of further improving the diagnostic performance of endoscopic ultrasound. Although novel puncture needles have been specifically designed for collecting sufficient tissue specimens, clinical studies have indicated no clear difference in diagnostic performance between these novel needles and conventional puncture needles. Recently, a needle with Franseen geometry was developed specifically for EUS-FNA biopsy. Due to the characteristic shape of its tip, the Franseen needle is expected to be effective for scraping tissues, thus potentially increasing the diagnostic accuracy of EUS-FNA biopsy. We plan to carry out a prospective, multicenter, open-labeled, controlled trial to compare conventional and Franseen needles in terms of the diagnostic accuracy of EUS-FNA for evaluating the malignancy of pancreatic mass lesions., Methods/design: The study will enroll 520 patients with pancreatic mass managed at any of 21 participating endoscopic centers. Lesion samples obtained using 22G conventional and Franseen needles will be assessed to compare the efficacy and safety of these two types of needles in EUS-FNA for evaluating the malignancy of mass lesions in the pancreas. Tissue samples will be fixed in formalin and processed for histologic evaluation. For the purpose of this study, only samples obtained with the first needle pass will be used for comparing the: (i) accuracy of the malignancy diagnosis, (ii) sensitivity and specificity for the malignancy diagnosis, (iii) procedure completion rate, (iv) sample cellularity, and (v) incidence of complications. Patient enrollment begins on July 17, 2018., Discussion: The outcomes of this study may provide insight into the optimal needle choice for evaluating the malignancy of pancreatic solid lesions, thus aiding in the development of practice guidelines for pancreatic diseases., Trial Registration: University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR), UMIN000030634. Registered on 29 December 2017. http://www.umin.ac.jp/ Version number: 01.2017.12.28.

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 and Aim: When endoscopic retrograde cholangiopancreatography (ERCP) fails in patients with malignant distal biliary obstruction, endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) is an alternative. It has high technical and clinical success rates, but also has high adverse event rates. This prospective cohort study was aimed to evaluate the clinical efficacy and safety of EUS-CDS with our newly developed partially covered self-expandable metal stent with a thin delivery system., Methods: Patients consisted of all consecutive patients in three tertiary referral centers with unresectable malignant distal obstruction in whom ERCP failed and in whom EUS-CDS with the thin delivery system was selected as the second-line approach. Rates of clinical success, technical success, technical success in cases not requiring fistulous tract dilation, adverse events, and stent dysfunction were determined., Results: In the 20 patients, technical and clinical success rates were 95.0% (19/20) and 100% (19/19), respectively. In 31.6% (6/19), the delivery system was successfully inserted into the bile duct without requiring a fistulous-tract dilatation device. These patients had significantly shorter procedure times than patients requiring fistulous-tract dilatation (12.7 ± 3.1 vs 23.2 ± 2.1 min; P < 0.01). One patient (5.0%) who required fistulous dilation had an adverse event, which was managed conservatively. There were no procedure-related deaths. During follow up, four patients (21.1%) developed stent dysfunction. Reintervention was successful in all cases., Conclusions: The EUS-CDS approach had 95% technical and 100% clinical success rates, with adverse events reported in 5% of cases. EUS-CDS may become safer if efforts are made to avoid the dilation step (UMIN 000023938)., (© 2018 Japan Gastroenterological Endoscopy Society.)

Objectives: Percutaneous transhepatic gallbladder drainage (PTGBD) is widely used for patients with acute cholecystitis. There are little data on the efficacy and safety of endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) replacement of PTGBD in patients who cannot undergo cholecystectomy., Methods: This multicenter retrospective study in Japan reviewed records of patients who underwent EUS-GBD to replace PTGBD between January 2010 and December 2017. Outcomes evaluated included technical success, defined as successful stent placement between the gastrointestinal lumen and the gallbladder; clinical success, defined as subsequent removal of the percutaneous catheter; adverse events; and stent patency., Results: EUS-GBD was performed in 21 patients (14 women, mean age 77.5 ± 8.0 years) to replace PTGBD that had been instituted for acute cholecystitis (n = 19) or obstructive jaundice (n = 2). Technical success was achieved in 19 (90.5%). The median period from PTGBD placement to EUS-GBD was 11 days (range, 6-68 days). The mean procedure time was 19.5 ± 5.1 min. No early adverse events were observed. There were three late adverse events, distal stent migration in two cases and stent occlusion causing recurrent cholecystitis in one patient. Reintervention was required in two patients. The percutaneous catheter was removed after EUS-GBD in 17 patients at a median of 7 days (range, 2-20 days). The duration of stent patency was 139 days (range, 8-664 days)., Conclusions: Where ongoing gallbladder drainage is required, conversion from PTGBD to EUS-GBD is a feasible, effective, and safe technique for patients who cannot undergo cholecystectomy., (© 2018 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 and Aim: Recently, the digital single-operator cholangioscope (SPY-DS) has become available. This system may allow diagnosis by direct visualization and allow performance of various therapeutic procedures. The aim of the present study was to prospectively evaluate the clinical utility of DSOCS for diagnostic and therapeutic procedures for biliary disease., Methods: Technical success was defined as successful visualization of target lesions in the biliary tract and carrying out forceps biopsy as a diagnostic procedure, and successfully carrying out treatment such as guidewire insertion for the area of interest, electrohydraulic lithotripsy (EHL), or migrated stent removal. Also, the present study aimed at investigating diagnostic yield of the cholangioscopic findings and biopsy specimens., Results: A total of 55 consecutive patients were prospectively enrolled in this study; a diagnostic procedure was done in 33 patients, and a therapeutic procedure was done in 22 patients. Overall accuracy of visual findings was 93%, with a sensitivity of 83%, a specificity of 89%, positive predictive value (PPV) of 83%, and negative predictive value (NPV) of 100%. However, the overall accuracy of forceps biopsy was 89%, with a sensitivity, specificity, and PPV of 100%, and NPV of 90%. Overall technical success rate of therapeutic procedures such as selective guidewire insertion, EHL or migrated stent removal was 91% (20/22). Finally, adverse events were seen in two cases in the diagnostic group, but were not seen in the therapeutic group., Conclusion: Although additional cases and a randomized, controlled study with another cholangioscope are needed, diagnostic and therapeutic procedures using SPY-DS appear to be feasible and safe., (© 2017 Japan Gastroenterological Endoscopy Society.)

We studied the relationship between physiologic parameters in cardiopulmonary exercise testing (CPET) and prognosis in terms of survival time in patients with chronic obstructive pulmonary disease (COPD) in order to accurately assess the severity of the disease. From a group of 195 patients with COPD who had consecutively undergone CPET between July 1989 and October 1997, we enrolled 120 subjects (mean age 67.6 years, 104 males) with exertional dyspnoea into a cohort protocol. Of these subjects, 34 (28.3%) died during the 3-5-year follow-up period after CPET. By univariate analysis, the following factors were significantly associated with survival time: age, body mass index, %FVC, %FEV1, FEV1%, PaCO2 at rest, severity of exercise-induced hypoxemia evaluated by DeltaPaO2/DeltaVO2 (PaO2-slope), oxygen uptake, ventilation, tidal volume, PaCO2 and oxygen pulse at maximum exercise, as well as prescribing long-term oxygen therapy. By multivariate analysis, age and the PaO2-slope showed significance as independent prognostic factors, and the PaO2-slope was most closely associated with the survival time. These results reveal that CPET is a useful technique to accurately assess the relationship between the functional impairments and the prognosis of patients with COPD.