Double-tract reconstruction is superior in controlling reflux esophagitis and enhancing quality of life after proximal gastrectomy: Results from a prospective randomized controlled clinical trial in China

Abstract Background Proximal gastrectomy (PG) is an alternative function preserving surgery. The aim of this study was to prospectively compare double-tract reconstruction (DTR) and esophagogastrostomy (EG) after PG regarding the incidence of reflux esophagitis, quality of life (QOL)，nutritional status and surgical safety. Method This study was a prospective, randomized controlled trial conducted in a single institute. Patients eligible for PG were enrolled and randomly assigned to the EG group and DTR group. The characteristic of patients, parameters of surgical safety, the incidence of reflux esophagitis which was the primary outcome of this trial, nutrition status and the QOL were compared between the EG and the DTR group. Blinding was not involved in this trial. Results 73 patients eligible for PG were enrolled in the study and randomly assigned to the EG group (37 patients) and DTR group (36 patients). The incidence of reflux esophagitis after PG was significantly lower in the DTR group than that of the EG group (8.3% vs. 32.4%, P=0.019). In multivariate analysis, reconstruction method was the only significant factor affecting the incidence of reflux esophagitis. The DTR group demonstrated a more favorable QOL than the EG group after PG in the global health status, emotional functioning and symptoms such as fatigue, nausea and vomiting, pain, insomnia, appetite loss, dysphagia, reflux, eating restrictions, anxiety, dry mouth and taste change were more severe in the EG group patients. Nutritional status was balanced within the EG group and the DTR group after PG including BMI, levels of hemoglobin, serum albumin and serum total protein. The operation time was longer in the DTR group than in the EG group (191min vs. 221min, P=0.001) while surgical safety was similar in the two groups regarding blood loss volume, postoperative complications and hospital stays. Conclusion Our research demonstrated that DTR was superior to EG after PG in terms of the incidence of reflux esophagitis and provided a more satisfied QOL without increasing surgical complications or sacrificing nutritional status, thus making DTR a better reconstruction method after PG. Trial registration: ClinicalTrials .gov, NCT03613142, registered on August 2, 2018.