Safety and Feasibility of Linear Stapling Device with Bioabsorbable Polyglycolic Acid Sheet for Duodenal Closure in Gastric Cancer Surgery: A Multi-institutional Phase II Study.

Misawa, Kazunari; Yoshikawa, Takaki; Ito, Seiji; Cho, Haruhiko; Ito, Yuichi; Ogata, Takashi

BACKGROUND Duodenal stump fistula (DSF) after gastrectomy is of low frequency but a critical complication in gastric cancer surgery. Manual oversewing for reinforcement of the duodenal stump is not applicable when free longitudinal margin is short and has technical difficulties in laparoscopic surgery. This trial evaluated the safety and feasibility of using a linear stapler with bioabsorbable polyglycolic acid (PGA) sheet for duodenal stump closure and reinforcement in gastric cancer surgery. METHODS This multi-institutional, prospective phase II trial included gastric cancer patients who were scheduled to undergo distal or total gastrectomy with R-Y reconstruction. In all cases, duodenum was transected using a linear stapler with PGA sheet. The primary endpoint was the incidence of postoperative DSF. Sample size was set at 100 patients considering an expected value of 3% and threshold value of 8% with one-sided testing at a 10% significance level. RESULTS Between June 2014 and June 2015, a total of 100 patients were registered in this trial. Postoperative DSF was observed in two cases (2.0%, 90% CI 0.4-6.2%) which was developed on postoperative days 13 and 20. Intraoperative bleeding at the duodenal stump staple line was observed in one case but was easily controlled without additional suturing. Postoperative bleeding was not observed in any of the cases. CONCLUSION This study suggested that the use of PGA sheet as a reinforcement material for closure of the duodenal stump during gastrectomy for gastric cancer is both safe and feasible. Trial registration number UMIN 000014398.