A 3-Arm Study Comparing the Efficacy of Anti-Reflux Reconstruction Protocols After Laparoscopic Proximal Gastrectomy

In the trial, 180 patients with early upper-third early gastric cancer and Siewert type II/III esophagogastric junction cancer will be enrolled and then randomly assigned to one of three groups: Group A (single-tract jejunal interposition n = 60), Group B (double-tract reconstruction, n = 60), or Group C (tube-like stomach reconstruction, n = 60). The primary co-end points were the incidence of reflux esophagitis at 2 years postoperatively. The secondary end points included the incidence of anastomotic leakage and anastomotic stenosis, operative time, intraoperative blood loss, quality of life, overall survival, and disease-free survival. Quality of life outcomes were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) 30-item core questionnaire (C30) and the EORTC QLQ stomach cancer-specific questionnaire at 3 months, 12 months, and 24 months.

Inclusion criteria

• Age between 18-75 years old, male or female;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 (indicating fully active and able to continue all predisease activities without restriction) or 1 (indicating restricted in physically strenuous activities but ambulatory and able to perform work of a light or sedentary nature);
• American Society of Anesthesiology physical status classification of I (indicating normal and healthy), II (indicating mild systemic disease), or III (indicating severe systemic disease);
• Pathological diagnosis of preoperative endoscopic biopsy: the tumor is located in the upper 1/3 of the stomach (including the esophagogastric junction), and the clinical staging of gastric cancer Ia and Ib (T1N0M0, T1N1M0, and T2N0M0) (14) according to the eighth edition of the AJCC;
• Patients without contraindications to surgery;
• Voluntary participation by signing the written informed consent form approved by the institutional review board before study participation;

Exclusion criteria

• Receipt of chemotherapy or radiotherapy for the treatment of GC before either surgical procedure
• Combined resection required due to other diseases (except cholecystectomy).
• History of cancer or concurrent cancer in other organs.
• Previous or current receipt of treatment for systemic inflammatory disease or history of gastrectomy.
• Patients with coagulation dysfunction which could not be corrected;
• Vulnerable status (eg, lacking decision-making capacity, pregnant, or planning to become pregnant).
• Receipt of chemotherapy or radiotherapy before either surgical procedure.