Abstract
PURPOSE: Laparoscopic gastrectomy is accepted as a standard treatment for patients with early gastric cancer in Korea, Japan, and China. However, duodenal stump leakage remains a fatal complication after gastrectomy. We conducted a prospective phase II study to evaluate the safety of the new technique of laparoscopic reinforcement suture (LARS) on the duodenal stump. MATERIALS AND METHODS: The estimated number of patients required for this study was 100 for a period of 18 months. Inclusion criteria were histologically proven gastric adenocarcinoma treated with laparoscopic distal or total gastrectomy and Billroth II or Roux-en-Y reconstruction. The primary endpoint was the incidence of duodenal stump leakage within the first 30 postoperative days. The secondary endpoints were early postoperative outcomes until discharge. RESULTS: One hundred patients were enrolled between February 2016 and March 2017. The study groups consisted of 65 male and 35 female patients with a mean age (years) of 62.3. Of these, 63 (63%) patients had comorbidities. The mean number of retrieved lymph nodes was 38. The mean operation time was 145 minutes including 7.8 minutes of mean LARS time. There was no occurrence of duodenal stump leakage. Thirteen complications occurred, with one case of reoperation for splenic artery rupture and one case of mortality. CONCLUSIONS: Based on the results of this prospective phase II study, LARS can be safely performed in a short operation period without development of duodenal stump leakage. A future randomized prospective controlled trial is required to confirm the surgical benefit of LARS compared to non-LARS.