Effects of perioperative ERAS pathway management VS traditional management on clinical outcomes in laparoscopic-assisted radical resection of distal gastric cancer The GISSG18-01 Randomized Clinical Trial

Background: As well known, the incidence of gastric cancer in East Asian countries is much higher than the international average. Therefore, improving the prognosis of patients and establishing effective clinical pathways are important topics for the prevention and treatment of gastric cancer. At present, the enhanced recovery after surgery (ERAS) pathway is widely used in the field of gastric surgery. Many RCT studies have proven that the ERAS regimen can not improve the short-term clinical outcomes of gastric cancer patients. However, a prospective study on the effect of the ERAS pathway on the prognosis of gastric cancer patients has not been reported. This trial aims to confirm whether ERAS pathway can improve disease-free survival (DFS) and overall survival (OS) in patients undergoing laparoscopic-assisted radical resection for distal gastric cancer.Methods/design: This study is a prospective, multicenter, randomized controlled trial (RCT). This experiment will include randomly divided groups, the experimental group and the control group, according to a proportion of 1:1. The perioperative period of the experimental group will be managed according to the ERAS pathway, and the control group will be managed according to the traditional management mode. An estimated 400 patients will be enrolled. The main endpoint is to compare the 3-year OS and PFS between the two groups.Discussion: This RCT should demonstrate whether ERAS pathway is superior to traditional treatment on inflammatory indexes, short-term clinical outcome and survival for laparoscopic assisted radical resection of distal gastric cancer.Our data can provide evidence that the ERAS pathway improves survival in patients with gastric cancer.Trial registration: Chinese Clinical Trial Registry, CHiCTR1900022438. Registered on 11 April 2019