Regional or Extended LymphAdenectomY trial(RELAY-trial)in Hilar Cholangiocarcinoma Resection—a Prospective, Multicenter, Randomized Controlled Trial

Abstract

Introduction: Although lymph node metastasis has been considered an important prognostic factor for hilar cholangiocarcinoma, the impact of extensive lymph node dissection on the prognosis of hilar cholangiocarcinoma have not been fully clarified. The objective of this study was to analyze the survival outcome and the clinicopathological factors that influence survival and recurrence of extended lymph node dissection in hilar cholangiocarcinoma Method: This study was a multicenter, prospective, randomized controlled clinical study. We estimated that 734 patients would be required. Those patients would be randomly assigned to the regional lymph node dissection group and the extended lymph node dissection group at 1:1. The perioperative mortality would be compared between the two groups. Postoperative complications, disease free survival (DFS), and overall survival (OS) would be used to explore the safety and necessity of extended lymphadenectomy in hilar cholangiocarcinoma. Result: Until March 18th. 2019, 115 patients were collected, The Clavien-Dindo I-II complication rate of extended lymph node dissection of hilar cholangiocarcinoma was significantly elevated compared to the regional dissection group. However, there was no significant difference concerning Clavien-Dindo III-IV complications. The survival time of extended lymph node dissection group was better than that of regional lymph node dissection group. Conclusion: Extended lymph node dissection of hilar cholangiocarcinoma is safe and is important for improving prognosis. This clinical trial is still going on, hopefully, it would shed light on choosing of lymph node dissection strategy in hilar cholangiocarcinoma.