Multicenter prospective randomized controlled trial of comparing laparoscopic proximal gastrectomy and laparoscopic total gastrectomy for upper third early gastric cancer (KLASS-05)

Abstract

TPS184Background: Proximal gastrectomy (PG) is rarely performed for upper third early gastric cancer (EGC) because of postoperative reflux esophagitis. Recently, PG with double tract reconstruction was introduced and reported to have a reflux of approximately the same frequency as total gastrectomy (TG) with esophagojejunostomy. PG has several theoretical advantages over TG but has not yet been proven in randomized controlled trial. This study aimed to provide scientific evidence of laparoscopic PG with double tract reconstruction as a standard procedure for proximal EGC. Methods: The present trial is multicenter, prospective, randomized, controlled trial with superiority design. A total of 138 patients with upper third cT1N0M0 gastric adenocarcinoma are randomized to laparoscopic PG with double tract reconstruction and laparoscopic TG with esophagojejunostomy. Patients are enrolled for two years and followed up for two years. Primary co-endpoints are hemoglobin change and vitamin B12 cumulative supplemen...