Laparoscopic versus open distal gastrectomy with d2 lymphadenectomy in treatment of locally T4A gastric cancer: the protocol of a randomized controlled trial.

[BACKGROUND] Gastric cancer (GC) remains one of the leading causes of cancer-related mortality worldwide. While laparoscopic gastrectomy (LG) has been widely adopted for early and locally advanced gastric cancer (AGC), its safety and oncological efficacy in T4a GC remain unclear. To date, no randomized controlled trials have specifically examined the role of LG in the treatment of T4a GC. This study aims to provide robust evidence comparing the short- and long-term outcomes of laparoscopic distal gastrectomy (LDG) versus open distal gastrectomy (ODG) in resectable T4a GC.

[METHODS] This is a phase III, randomized controlled, non-inferiority trial. Patients with clinical T4a GC (cT4aN0-3M0) suitable for distal gastrectomy with D2 dissection will be randomly assigned in a 1:1 ratio to undergo either LDG or ODG. A total 240 patients (120 each group) are required to statistically show non-inferiority of the LDG with respect to the primary end-point, 3-years disease-free survival (DFS). Secondary endpoints include morbiity, mortality, postoperative recovery, and quality of life.

[DISCUSSION] This study is the first prospective randomized trial specifically designed to compare laparoscopic and open approaches for T4a GC. By standardizing surgical techniques and ensuring experienced surgeons perform the procedures, this trial aims to establish whether LDG can provide equivalent oncological outcomes while reducing perioperative morbidity and enhancing postoperative recovery. The findings will provide high-quality evidence to inform future guidelines and clinical decision-making in the management of T4a gastric cancer.

[TRIAL REGISTRATION] This study is registered at ClinicalTrials.gov (NCT04384757), version 6. Registration Date: 08/05/2020.