Tunnel Anastomosis vs Double-Tract Jejunal Interposition Reconstruction After Proximal Gastrectomy: Protocol for a Multicenter Prospective Randomized Controlled Trial.

Background: Tunnel anastomosis is a novel anastomotic technique for digestive tract reconstruction following proximal gastrectomy. A previous retrospective study by our team demonstrated its favorable antireflux effect; therefore, we hypothesize that tunnel anastomosis is noninferior to double-tract jejunal interposition reconstruction in preventing postoperative reflux esophagitis, and we will conduct this prospective study to further validate this assumption. Objective: In this study, we will prospectively compare tunnel anastomosis with the currently more prevalent double-tract jejunal interposition reconstruction technique to further validate its safety and efficacy. Methods: This is a multicenter prospective randomized controlled study that will enroll 240 patients who will undergo proximal gastrectomy. The study will be divided into 2 groups: the tunnel anastomosis group and the double-tract jejunal interposition reconstruction group, with 120 patients in each group. Patients will undergo clinical assessments and complete questionnaires preoperatively, as well as at the 3rd, 6th, and 12th months postoperatively. The primary end point is the incidence of reflux esophagitis within 1 year. The secondary end points include perioperative safety, postoperative quality of life, and postoperative nutritional status. Results: Recruitment of patients commenced in March 2022 and is scheduled to conclude in February 2027. The follow-up for all enrolled patients will be completed by February 2028. Conclusions: To our knowledge, this is the first prospective study on this technique, aiming to provide novel insights into the methods of digestive reconstruction following proximal gastrectomy.