Effect of perioperative probiotic supplements on the short-term clinical outcomes of patients undergoing laparoscopic or robotic radical gastrectomy after neoadjuvant chemotherapy: Study protocol for a multicenter randomized controlled trial (GISSG2023 - 01 Study)

作者：Gan Liu, Shougen Cao, Xiaodong Liu, Yulong Tian, Wenbin Yu, Jie Chai, Leping Li, Xixun Wang, Xianqun Chu, Quanhong Duan, Jianjun Qu, Hao Wang, Huanhu Zhang, Xinjian Wang, Xizeng Hui, Daogui Yang, Shaofei Zhou, Yinlu Ding, Hongbo Wang, Fengqiang Zhou, Baoguang Hu, Peiming Guo, Lixin Jiang, Guangyong Zhang, Qiang Pan‐Hammarström, Xiaobin Zhou, Yanbing Zhou · 发表于：BMC Cancer · 年份：2025 · DOI：10.1186/s12885-025-14115-x · 被引用次数：5 · 研究领域：Gastric Cancer Management and Outcomes、Enhanced Recovery After Surgery、Colorectal Cancer Surgical Treatments

BACKGROUND: Gastric cancer is a common malignant tumor, and radical gastrectomy can markedly improve the prognosis of gastric cancer patients. However, some patients are diagnosed with advanced gastric cancer before receiving any antitumor therapy and need to receive neoadjuvant chemotherapy (NACT). Previous studies have shown that NACT may cause gut barrier dysfunction and intestinal dysbacteriosis which may further lead to infections. Probiotics have the potential to reduce postoperative infections and improve short-term outcomes after abdominal surgery; however, no large-sample, multicenter, randomized clinical trials have been conducted to explore the effectiveness of probiotics in gastric cancer patients receiving NACT. So we proposed a hypothesis that probiotics can improve short-term outcomes after minimally invasive radical gastrectomy in gastric cancer patients receiving NACT and designed this multicenter randomized controlled trial with the objective to verify this hypothesis. METHODS/DESIGN: The GISSG 2023-01 study will be a prospective, open-label, multicenter RCT to verify whether perioperatively probiotic supplementation (begin from the end of the last cycle of NACT to postoperative day 7 or the discharge day) can reduce postoperative infections and improve recovery of gastrointestinal function and other short-term outcomes after minimally invasive radical gastrectomy in gastric cancer patients receiving NACT. A total of 318 patients who meet the inclusion crite...