Surgical Strategies for Siewert Type II Esophagogastric Junction Carcinomas: A Randomized Controlled Trial

Abstract

Objective: To determine the ideal surgical approach for Siewert type II esophagogastric junction (EGJ) carcinomas, an open-label and randomized controlled trial was conducted. Background: Siewert type II EGJ carcinomas have dragged considerable interest for the choice of surgical approach because of a borderline location between esophagus and stomach. A JCOG 9502 RCT in Japan showed that abdominal-transhiatal approach is more recommended for EGJ carcinomas because of its less morbidity and equivalent survival after abdominal-transhiatal approach. Still, further concerns on selection either resection extent (total or proximal gastrectomy) or reconstruction methods remain elucidated. Methods: An open-label and randomized controlled trial was conducted in a single cancer center between January 1, 2014 and August 30, 2016. A total of 105 patients with Siewert type II EGJ carcinoma were randomly assigned via a computer-generated randomization to receive either proximal gastrectomy plus jejunal interposition (PG+JI) (n=35) or proximal gastrectomy plus esophagogastrostomy (PG+EG) (n=35) or total gastrectomy plus Roux-en-Y esophagojejunostomy (TG+RY) (n=35). The primary endpoint was patient clinical indices of perioperative and post-operative outcomes. The secondary endpoint was nutrition index, quality of life and 2-year overall survival. The study was registered at Chinese Clinical Trial Registry (no. ChiCTR-IIR-160077330). Results: A total of 14 patients were excluded during operation or follow-up, and therefore 29, 30 and 32 were available in PG+JI, PG+EG and TG+RY groups. PG+JI group took longest reconstruction time among the three groups (33.93±6.0 minutes vs 21.97±3.30 minutes vs 30.56±4.26; P<0.001). PG+JI and PG+EG groups both took relatively less time for first ventilation (59.79±11.72 vs 59.93±8.37 vs 68.84±7.98; P<0.001), and less length of hospital stay (11.55±2.43 vs 11.57±1.72 vs 13.97±3.51; P<0.001), in comparison to TG+RY group. There was no operative mortality in all the three groups. In per-protocol analysis, PG+JI group showed least overall complication rates (3.4% vs 26.7% vs 25%) and least reflux symptom (3.4% vs 26.7% vs 6.3%) among the three groups. TG+RY group showed least in single food intake, weight loss, hemoglobin, albumin, pepsin and gastrin among the three groups. During 2-year follow-up, there is no difference in overall survival among three groups. Conclusion: Proximal gastrectomy is more recommended for early Siewert type II EGJ carcinomas because of its less morbidity, and equivalent overall survival with total gastrectomy, and jejunal interposition can be recommended as a satisfactory reconstruction approach after proximal gastrectomy. Funding: This study is supported by Natural Science Foundation of Jiangsu Province (BK20180274). Declaration of Interest: The authors have declared that no competing interests exist. Ethical Approval: The study was approved by the Institutional Review Board of the Shanxi Medical University (IRB File No. 2004-09-39). All participants signed consent form. An independent Data Safety Monitoring Committee reviewed the acquired data throughout the trial.