PMID- 33761729 OWN - NLM STAT- MEDLINE DCOM- 20210405 LR - 20230103 IS - 1536-5964 (Electronic) IS - 0025-7974 (Print) IS - 0025-7974 (Linking) VI - 100 IP - 12 DP - 2021 Mar 26 TI - Comparison of endoscopic ultrasound-guided choledochoduodenostomy and endoscopic retrograde cholangiopancreatography in first-line biliary drainage for malignant distal bile duct obstruction: A multicenter randomized controlled trial. PG - e25268 LID - 10.1097/MD.0000000000025268 [doi] LID - e25268 AB - INTRODUCTION: In patients with malignant distal bile duct obstruction and normal gastrointestinal anatomy, endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) is indicated when endoscopic retrograde cholangiopancreatography (ERCP) fails. The ERCP drainage route passes through the tumor, whereas the EUS-CDS route does not. Therefore, EUS-CDS is expected to have a longer stent patency than ERCP. However, for first-line biliary drainage, it remains unclear whether EUS-CDS or ERCP is superior in terms of stent patency. To reduce the frequency of highly adverse events (AEs) such as bile peritonitis or stent migration following EUS-CDS, we developed an antimigration metal stent with a thin delivery system for tract dilatation. This study is designed to assess whether EUS-CDS with this novel stent is superior to ERCP with a traditional metal stent in terms of stent patency when the two techniques are used for first-line drainage of malignant distal biliary obstruction. METHODS/DESIGN: This study is a multicenter single-blinded randomized controlled trial (RCT) involving 95 patients in four tertiary centers. Patients with malignant distal biliary obstruction that is unresectable or presents a very high surgical risk and who pass the inclusion and exclusion criteria will be randomized to EUS-CDS or ERCP in a 1:1 proportion. The primary endpoint is the stent patency rate 180 days after stent insertion. Secondary outcomes include the rates of technical success, clinical success, technical success in cases not requiring fistulous-tract dilation (only EUS-CDS group), procedure-related AEs, re-intervention success, patients receiving post-drainage chemotherapy, procedure time, and overall survival time. DISCUSSION: If EUS-CDS is superior to ERCP in terms of stent patency and safety for the first-line drainage of malignant distal biliary obstruction, it is expected that the first-line drainage method will be changed from ERCP to EUS-CDS, and that interruption of chemotherapy due to stent dysfunction can be avoided. TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR), ID: UMIN000041343. Registered on August 6, 2020. https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047201Version number: 1.2, December 7, 2020. CI - Copyright (c) 2021 the Author(s). Published by Wolters Kluwer Health, Inc. FAU - Itonaga, Masahiro AU - Itonaga M AD - Second Department of Internal Medicine. FAU - Kitano, Masayuki AU - Kitano M AD - Second Department of Internal Medicine. FAU - Yoshikawa, Takanori AU - Yoshikawa T AD - Clinical Study Support Center, Wakayama Medical University, Wakayama. FAU - Ashida, Reiko AU - Ashida R AD - Second Department of Internal Medicine. FAU - Yamashita, Yasunobu AU - Yamashita Y AD - Second Department of Internal Medicine. FAU - Hatamaru, Kenichi AU - Hatamaru K AD - Second Department of Internal Medicine. FAU - Takenaka, Mamoru AU - Takenaka M AD - Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka. FAU - Yamazaki, Tomohiro AU - Yamazaki T AD - Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka. FAU - Ogura, Takeshi AU - Ogura T AD - The Second Department of Internal Medicine, Osaka Medical College, Takatsuki. FAU - Nishioka, Nobu AU - Nishioka N AD - The Second Department of Internal Medicine, Osaka Medical College, Takatsuki. FAU - Sakai, Arata AU - Sakai A AD - Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan. FAU - Masuda, Atsuhiro AU - Masuda A AD - Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan. FAU - Shiomi, Hideyuki AU - Shiomi H AD - Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan. FAU - Shimokawa, Toshio AU - Shimokawa T AD - Clinical Study Support Center, Wakayama Medical University, Wakayama. LA - eng GR - no/the Japanese Foundation for Research and Promotion of Endoscopy/ PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PL - United States TA - Medicine (Baltimore) JT - Medicine JID - 2985248R SB - IM MH - *Bile Duct Neoplasms/complications/pathology MH - *Cholangiopancreatography, Endoscopic Retrograde/adverse effects/instrumentation/methods MH - *Choledochostomy/adverse effects/instrumentation/methods MH - *Cholestasis/diagnostic imaging/etiology/surgery MH - Drainage/methods MH - Endosonography/*methods MH - Female MH - Humans MH - Male MH - Middle Aged MH - Outcome Assessment, Health Care MH - *Peritonitis/etiology/prevention & control MH - *Postoperative Complications/etiology/prevention & control MH - Prosthesis Design MH - Prosthesis Failure MH - *Stents MH - Surgery, Computer-Assisted/methods PMC - PMC9282038 COIS- The authors report no conflicts of interest. EDAT- 2021/03/26 06:00 MHDA- 2021/04/07 06:00 PMCR- 2021/03/26 CRDT- 2021/03/25 01:02 PHST- 2021/03/04 00:00 [received] PHST- 2021/03/05 00:00 [accepted] PHST- 2021/03/25 01:02 [entrez] PHST- 2021/03/26 06:00 [pubmed] PHST- 2021/04/07 06:00 [medline] PHST- 2021/03/26 00:00 [pmc-release] AID - 00005792-202103260-00105 [pii] AID - MD-D-21-01494 [pii] AID - 10.1097/MD.0000000000025268 [doi] PST - ppublish SO - Medicine (Baltimore). 2021 Mar 26;100(12):e25268. doi: 10.1097/MD.0000000000025268.