Regional lymphadenectomy vs. extended lymphadenectomy for hilar cholangiocarcinoma (Relay-HC trial): study protocol for a prospective, multicenter, randomized controlled trial
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
Affiliations
Min He
Department of Biliary-Pancreatic Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Xinsen Xu
Department of Biliary-Pancreatic Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Hao Feng
Department of Biliary-Pancreatic Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Wei Chen
Department of Biliary-Pancreatic Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Houbao Liu
Department of General Surgery, Zhongshan Hospital, School of Medicine, Shanghai Fu Dan University
Yongjie Zhang
Department of Biliary Surgery, The Third Affiliated Hospital, The Second Military Medical University
Jianming Wang
Department of General Surgery, Tongji Medical College, Hua Zhong University of Science&Technology
Zhimin Geng
Department of General Surger, The First Affiliate Hospital of Xi An Jiao Tong University
Yudong Qiu
Department of General Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Weidong Duan
Department of General Surgery, Chinese PLA General Hospital, Medical School of Chinese PLA
Xiangcheng Li
Department of General Surgery, The First Affiliated Hospital with Nan Jing Medical University
Xuting Zhi
Department of General Surgery, Qilu Hospital of Shandong University
Weihua Zhu
Department of General Surgery, Peking University People’s Hospital
Fuyu Li
Department of General Surgery, West China Hospital Sichuan University
Jiangtao Li
Department of General Surgery, The Second Affiliated Hospital of Zhejiang University School of Medicine
Shengping Li
Department of General Surgery, Sun Yat-Sen University Cancer Center
Yu He
Department of General Surgery, The First Hospital Affiliated to AMU (Southwest Hospital)
Zhiwei Quan
Department of General Surgery, Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Jian Wang
Department of Biliary-Pancreatic Surgery, Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine
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.
