PMID- 36221399
OWN - NLM
STAT- MEDLINE
DCOM- 20221013
LR  - 20230103
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Print)
IS  - 0025-7974 (Linking)
VI  - 101
IP  - 40
DP  - 2022 Oct 7
TI  - Bilateral verses bilateral with tri-segmental endoscopic drainage using metal 
      stents for high-grade malignant hilar biliary obstructions: A multicenter, 
      randomized controlled trial: BRAVE study (BRAVE study).
PG  - e30857
LID - 10.1097/MD.0000000000030857 [doi]
LID - e30857
AB  - INTRODUCTION: Bilateral endoscopic drainage with self-expanding metallic stent 
      (SEMS) can be used to manage hilar malignant biliary obstruction (HMBO) more 
      effectively in comparison to unilateral drainage. An increased drainage area is 
      predicted to prolong stent patency and patient survival. However, few reports 
      have described the utility of trisegmental drainage and the benefits of using 
      trisegmental drainage remain unknown. Thus, we launched a randomized clinical 
      trial (RCT) to compare the clinical outcomes between bilateral and trisegmental 
      drainage using SEMSs in patients with high-grade HMBO. METHODS AND ANALYSIS: This 
      study was conducted as a multicenter randomized control trial (RCT) in 8 
      high-volume medical centers in Japan, and will prove the non-inferiority of 
      bilateral drainage to trisegmental drainage. Patients with unresectable HMBO with 
      Bismuth type IIIa or IV who pass the inclusion and exclusion criteria will be 
      randomized to receive bilateral or trisegmental drainage at a 1:1 ratio. At each 
      center, the on-site study investigators will obtain informed consent from the 
      candidates, and will use an electronic data capture system (REDCap) to input 
      necessary information, and register candidates with the registration secretariat. 
      The primary endpoint is the rate of non-recurrent biliary obstruction (RBO) at 
      180 days after SEMSs placement. A -10% non-inferiority margin is assumed in the 
      statistical analysis of the primary endpoint. Secondary endpoints include the 
      rate of technical and clinical success, time to recurrent biliary obstruction 
      (TRBO), causes of RBO, procedure-related adverse events (AEs), procedure time, 
      TRBO with or without endoscopic sphincterotomy, overall survival, and the 
      technical and clinical success rates at reintervention. DISCUSSION: If the 
      non-inferiority of bilateral drainage is demonstrated, it is predicted that the 
      procedure time will be shortened and the medical cost will be reduced, which will 
      be beneficial to the patient and the medical economy. TRIAL REGISTRATION: 
      Registered in Japan Registry of Clinical Trial-Registration (trial number. 
      jRCTs062220038). This version number 1. Protocol dated Jun 23, 2022.
CI  - Copyright (c) 2022 the Author(s). Published by Wolters Kluwer Health, Inc.
FAU - Matsumoto, Kazuyuki
AU  - Matsumoto K
AUID- ORCID: 0000-0002-5102-7452
AD  - Department of Gastroenterology and Hepatology, Okayama University Hospital, 
      Okayama, Japan.
FAU - Mitsuhashi, Toshiharu
AU  - Mitsuhashi T
AD  - Center for Innovative Clinical Medicine, Okayama University Hospital, Okayama, 
      Japan.
FAU - Kawamoto, Hirofumi
AU  - Kawamoto H
AD  - Department of General Internal Medicine 2, Kawasaki Medical School, Okayama, 
      Japan.
FAU - Ishida, Etsuji
AU  - Ishida E
AD  - Department of Gastroenterology and Hepatology, Kurashiki Central Hospital, 
      Okayama, Japan.
FAU - Fujii, Masakuni
AU  - Fujii M
AD  - Department of Internal Medicine, Okayama Saiseikai General Hospital, Okayama, 
      Japan.
FAU - Akimoto, Yutaka
AU  - Akimoto Y
AD  - Department of Gastroenterology, Japanese Red Cross Okayama Hospital, Okayama, 
      Japan.
FAU - Seki, Hiroyuki
AU  - Seki H
AD  - Department of Gastroenterology, Mitoyo General Hospital, Kanonji, Japan.
FAU - Ishihara, Yuki
AU  - Ishihara Y
AD  - Department of Gastroenterology, Iwakuni Medical Center, Hiroshima, Japan.
FAU - Ogawa, Taiji
AU  - Ogawa T
AD  - Department of Gastroenterology, Tsuyama Central Hospital, Okayama, Japan.
FAU - Yamazaki, Tatsuhiro
AU  - Yamazaki T
AD  - Department of Gastroenterology and Hepatology, Okayama University Hospital, 
      Okayama, Japan.
FAU - Fujii, Yuki
AU  - Fujii Y
AD  - Department of Gastroenterology and Hepatology, Okayama University Hospital, 
      Okayama, Japan.
FAU - Kato, Hironari
AU  - Kato H
AD  - Department of Gastroenterology and Hepatology, Okayama University Hospital, 
      Okayama, Japan.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
RN  - U015TT5I8H (Bismuth)
SB  - IM
MH  - *Bile Duct Neoplasms/complications/surgery
MH  - Bismuth
MH  - *Cholestasis/complications/surgery
MH  - Drainage/methods
MH  - Humans
MH  - Stents/adverse effects
MH  - Treatment Outcome
PMC - PMC9543009
COIS- H.K. has received research finding from Zeon, Medical Inc. The other authors 
      declare that they have no conflict of interest in association with the present 
      study.
EDAT- 2022/10/13 06:00
MHDA- 2022/10/14 06:00
PMCR- 2022/10/07
CRDT- 2022/10/12 01:52
PHST- 2022/10/12 01:52 [entrez]
PHST- 2022/10/13 06:00 [pubmed]
PHST- 2022/10/14 06:00 [medline]
PHST- 2022/10/07 00:00 [pmc-release]
AID - 00005792-202210070-00076 [pii]
AID - 10.1097/MD.0000000000030857 [doi]
PST - ppublish
SO  - Medicine (Baltimore). 2022 Oct 7;101(40):e30857. doi: 
      10.1097/MD.0000000000030857.