Whole stomach versus narrow gastric tube reconstruction after esophagectomy for esophageal cancer (ATHLETE trial): study protocol for a randomized controlled trial.

Abstract

Background: There are two types of methods of creating a gastric conduit after esophagectomy for patients with esophageal cancer: narrow gastric tube reconstruction or whole stomach reconstruction. Whole stomach reconstruction with good blood perfusion was reported in a prospective cohort study to be safe and that it has the possibility to prevent anastomotic leakage (AL). We therefore planned a randomized controlled phase III study to investigate the superiority of whole stomach reconstruction over narrow gastric tube reconstruction after esophagectomy for esophageal cancer.

Methods: This is a single center, two-arm, open-label, randomized phase III trial. We calculated that 65 patients in each arm of this study and total study population of 130 patients are required according to our historical data on narrow gastric tube reconstruction and prospective data on whole stomach reconstruction. In the narrow gastric tube group, a 3.5-cm-wide gastric tube is made along the greater curvature of the stomach using linear staplers. Otherwise, in the whole stomach group, after the lymphadenectomy of the lesser curvature and No.2, the stomach is cut just below the esophagogastric junction using a linear stapler. The primary endpoint of this study is the incidence of AL. Secondary endpoints are the occurrence rate of anastomotic stenosis, the occurrence rate of pneumonia, the occurrence rate of all postoperative complications, the occurrence rate of reflux esophagitis, quality of life evaluation by EORTC QLQ-C30 and EORTC OES-18, nutritional evaluation, the amount of blood loss, postoperative hospital stays, and blood flow evaluation. Complications are evaluated using the Clavien-Dindo classification (version 2.0), and those of grade II or higher are considered to be postoperative complications.

Discussion: If the optimal method for creating a gastric conduit after esophagectomy is clarified, it may be possible to contribute to improving short-term and long-term surgical outcomes for patients undergoing surgery for esophageal cancer.

Trial registration: The protocol of ATHLETE trial was registered in the UMIN Clinical Trials Registry as UMIN000050677 ( http://www.umin.ac.jp/ctr/index.htm ). Date of registration: March 26, 2023. Date of first participant enrollment: March 27, 2023.