Double stapling technique versus hemi-double stapling technique for esophagojejunostomy with OrVil™ after laparoscopic total gastrectomy: a single-blind, randomized clinical trial

Background The transorally inserted anvil (OrVilT) is frequently selected for esophagojejunostomy after laparoscopic total gastrectomy (LTG) because of its versatility. During anastomosis with OrVilT, the double stapling technique (DST) or hemi-double stapling technique (HDST) can be selected by overlapping the linear stapler and the circular stapler. However, no studies have reported the differences between the methods and their clinical significance. Methods A randomized controlled clinical trial with a parallel assignment and single-blind outcomes assessment analysis was conducted. Patients with gastric cancer eligible for LTG who met the selection criteria were randomized. Preoperative characteristics and perioperative and postoperative outcomes were compared between the DST and HDST. The primary endpoint was an anastomosis-related complication, and the secondary endpoints were perioperative outcomes and postoperative complications, excluding anastomosis-related complications. Results Thirty patients with gastric cancer were eligible and randomized. LTG and esophagojejunostomy were successfully performed in all patients, without conversion to laparotomy. Preoperative characteristics, excluding preoperative chemotherapy, were not significantly different between the two groups. One anastomotic leakage of Clavien-Dindo classification grade = IIIa was observed in the DST, although no significant difference was found between the two groups (6.6% vs. 0%, P = 0.30). In the HDST, one case of anastomotic stricture required endoscopic balloon dilation. No significant differences were found in operative time, whereas the anastomosis time was significantly shorter in the HDST than in the DST (47.5 +/- 15.8 vs. 38.2 +/- 8.8 min, P = 0.028). Except for anastomosis-related complications, postoperative complications (P = 0.282) and postoperative hospital stay for the DST and HDST were not significantly different. Conclusions No superiority was found between the DST and HDST with OrVil (TM) in esophagojejunostomy of LTG for gastric cancer with respect to postoperative complications, whereas the HDST may be preferable in terms of the simplicity of the surgical technique. [GRAPHICS] .