Wang Juan, Yang Jun, Yang Xue Wen, Li Xiao Hua, Yang Jian Jun, Ji Gang
Department of Digestive Surgery, Xi Jing Hospital, The Fourth Military Medical University, Xi'an, People's Republic of China.
Cancer Manag Res. 2021 Jan 22;13:595-604. doi: 10.2147/CMAR.S285598. eCollection 2021.
Totally laparoscopic total gastrectomy (TLTG) using the overlap reconstruction method is associated with fewer postoperative complications and fast recovery than laparoscopic-assisted radical total gastrectomy (LATG). However, evidence on the safety and feasibility of TLTG (overlap reconstruction) in patients with advanced Siewert III esophagogastric junction cancer and gastric cancer of the upper and middle third of the stomach is scarce.
This study is a prospective, single-center, single-blind, two-arm randomized controlled trial designed to include 292 patients with advanced Siewert III esophagogastric junction cancer and gastric cancer of the upper and middle third of the stomach who will be randomly assigned to two groups: a TLTG overlap group (n=146) and an LATG group (n=146). The patients' demographics, pathological characteristics, intraoperative variables, postoperative complications, postoperative recovery variables, 3-year disease-free survival and 3-year overall survival will be collected and analyzed. The primary outcome is the postoperative complications within 30 days after surgery including intra-abdominal hemorrhage, anastomotic leakage, duodenal stump fistula, pancreatic fistula, chyle leakage, abdominal infection, intestinal obstruction, wound complications, pulmonary infection, pleural effusion, pulmonary embolism, cardiovascular and cerebrovascular complications, and deep vein thrombosis. The secondary outcomes are the 3-year disease-free survival and 3-year overall survival.
This trial will provide high-level evidence for the safety and feasibility of TLTG (overlap reconstruction) compared with LATG in advanced Siewert III esophagogastric junction cancer and the upper and middle third of gastric cancer.
This trial has been registered at the Chinese Clinical Trial Registry: ChiCTR1900025667 (registration date: September 4, 2019).
与腹腔镜辅助根治性全胃切除术（LATG）相比，采用重叠重建法的完全腹腔镜全胃切除术（TLTG）术后并发症更少，恢复更快。然而，关于TLTG（重叠重建）在晚期Siewert III型食管胃交界癌及胃中上段癌患者中的安全性和可行性的证据较少。
本研究是一项前瞻性、单中心、单盲、双臂随机对照试验，计划纳入292例晚期Siewert III型食管胃交界癌及胃中上段癌患者，随机分为两组：TLTG重叠组（n = 146）和LATG组（n = 146）。收集并分析患者的人口统计学资料、病理特征、术中变量、术后并发症、术后恢复变量、3年无病生存率和3年总生存率。主要结局是术后30天内的术后并发症，包括腹腔内出血、吻合口漏、十二指肠残端瘘、胰瘘、乳糜漏、腹腔感染、肠梗阻、伤口并发症、肺部感染、胸腔积液、肺栓塞、心脑血管并发症和深静脉血栓形成。次要结局是3年无病生存率和3年总生存率。
本试验将为TLTG（重叠重建）与LATG相比在晚期Siewert III型食管胃交界癌及胃中上段癌中的安全性和可行性提供高级别证据。
本试验已在中国临床试验注册中心注册：ChiCTR1900025667（注册日期：2019年9月4日）。
