Tunnel anastomosis versus double tract jejunal interposition reconstruction after proximal gastrectomy: Study protocol of a multicenter prospective randomized controlled trial (Preprint)

<sec> <title>BACKGROUND</title> Tunnel anastomosis is a novel anastomotic technique for digestive tract reconstruction following proximal gastrectomy. Our previous retrospective study demonstrated its favorable antireflux effect. </sec> <sec> <title>OBJECTIVE</title> In this study, we will prospectively compare this technique with the currently more prevalent double tract jejunal interposition reconstruction technique to further validate its safety and efficacy. </sec> <sec> <title>METHODS</title> This is a multicenter, prospective, randomized controlled study that will randomly enroll 240 patients who undergo proximal gastrectomy. The study will be divided into two groups: the tunnel anastomosis (TA) group and the double tract jejunal interposition reconstruction (DTJIR) 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 outcome is the incidence of reflux esophagitis. The secondary outcomes includ perioperative safety, postoperative quality of life, and postoperative nutritional status. </sec> <sec> <title>RESULTS</title> - </sec> <sec> <title>CONCLUSIONS</title> 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. </sec> <sec> <title>CLINICALTRIAL</title> The trial was registered on March 11th 2022 with registration number ChiCTR2200057397. </sec>