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.

Abstract

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.

• Authors: Masahiro Itonaga, Masayuki Kitano, Takanori Yoshikawa, Reiko Ashida, Yasunobu Yamashita, Kenichi Hatamaru, Mamoru Takenaka, Tomohiro Yamazaki, Takeshi Ogura, Nobu Nishioka, Arata Sakai, Atsuhiro Masuda, Hideyuki Shiomi, Toshio Shimokawa
• Journal: Medicine (Medicine (Baltimore)) Vol. 100 Issue 12 Pg. e25268 (Mar 26 2021) ISSN: 1536-5964 [Electronic] United States
• PMID: 33761729 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.

Topics

• Bile Duct Neoplasms (complications, pathology)
• Cholangiopancreatography, Endoscopic Retrograde (adverse effects, instrumentation, methods)
• Choledochostomy (adverse effects, instrumentation, methods)
• Cholestasis (diagnostic imaging, etiology, surgery)
• Drainage (methods)
• Endosonography (methods)
• Female
• Humans
• Male
• Middle Aged
• Outcome Assessment, Health Care
• Peritonitis (etiology, prevention & control)
• Postoperative Complications (etiology, prevention & control)
• Prosthesis Design
• Prosthesis Failure
• Stents
• Surgery, Computer-Assisted (methods)