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Published in: Trials 1/2019

Open Access 01-12-2019 | Cholangiocarcinoma | Study protocol

Regional lymphadenectomy vs. extended lymphadenectomy for hilar cholangiocarcinoma (Relay-HC trial): study protocol for a prospective, multicenter, randomized controlled trial

Authors: Min He, Xinsen Xu, Hao Feng, Wei Chen, Houbao Liu, Yongjie Zhang, Jianming Wang, Zhimin Geng, Yudong Qiu, Weidong Duan, Xiangcheng Li, Xuting Zhi, Weihua Zhu, Fuyu Li, Jiangtao Li, Shengping Li, Yu He, Zhiwei Quan, Jian Wang

Published in: Trials | Issue 1/2019

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Abstract

Background

The prognostic benefits and safety of extended lymphadenectomy for hilar cholangiocarcinoma remain uncertain. The available evidence is still insufficient concerning its retrospective aspect. The aim of this study is to explore the clinical effect and safety of extended lymphadenectomy compared to regional lymphadenectomy in patients with hilar cholangiocarcinoma.

Methods

The Relay-HC trial is a prospective, multicenter, and randomized controlled trial. Seven hundred and thirty-four eligible patients with resectable perihilar cholangiocarcinoma across 15 tertiary hospitals in China will be randomly assigned (1:1) to receive either regional lymphadenectomy or extended lymphadenectomy. The primary objective is to determine the overall survival after the two approaches. Secondary objectives of the study include the evaluation of perioperative mortality, postoperative complication, and disease-free survival. This study has been approved by the ethics committee of each participating hospital.

Discussion

The Relay-HC trial is designed to investigate the prognostic benefits and safety of expanded lymphadenectomy for hilar cholangiocarcinoma. Currently, it has never been investigated in a prospective randomized controlled clinical trial.

Trial registration

Chinese Clinical Trial Registry (ChiCTR), ChiCTR1800015688​. Registered on 15 April 2018.
Appendix
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Metadata
Title
Regional lymphadenectomy vs. extended lymphadenectomy for hilar cholangiocarcinoma (Relay-HC trial): study protocol for a prospective, multicenter, randomized controlled trial
Authors
Min He
Xinsen Xu
Hao Feng
Wei Chen
Houbao Liu
Yongjie Zhang
Jianming Wang
Zhimin Geng
Yudong Qiu
Weidong Duan
Xiangcheng Li
Xuting Zhi
Weihua Zhu
Fuyu Li
Jiangtao Li
Shengping Li
Yu He
Zhiwei Quan
Jian Wang
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3605-z

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