Cancer Management and Research (Jan 2021)
Comparison of Outcomes of Totally Laparoscopic Total Gastrectomy (Overlap Reconstruction) versus Laparoscopic-Assisted Total Gastrectomy for Advanced Siewert III Esophagogastric Junction Cancer and Gastric Cancer of Upper and Middle Third of Stomach: Study Protocol for a Single-Center Randomized Controlled Trial
Abstract
Juan Wang, Jun Yang, Xue Wen Yang, Xiao Hua Li, Jian Jun Yang, Gang Ji Department of Digestive Surgery, Xi Jing Hospital, The Fourth Military Medical University, Xi’an, People’s Republic of ChinaCorrespondence: Gang JiDepartment of Digestive Surgery, Xi Jing Hospital, The Fourth Military Medical University, Xi’an, People’s Republic of ChinaEmail [email protected] Jun YangDepartment of Digestive Surgery, Xi Jing Hospital, The Fourth Military Medical University, Xi’an, People’s Republic of ChinaEmail [email protected]: 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.Methods: 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.Discussion: 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.Trial Registration: This trial has been registered at the Chinese Clinical Trial Registry: ChiCTR1900025667 (registration date: September 4, 2019).Keywords: totally laparoscopic total gastrectomy, laparoscopic-assisted total gastrectomy, overlap reconstruction, Siewert III esophagogastric junction cancer, gastric cancer, randomized controlled trial
