Comparison of Double-tract and Tubular Gastric Anastomosis in Proximal Gastric Cancer

Qilu Hospital of Shandong University52 enrolled

Overview

This study includes patients diagnosed with proximal gastric cancer (Siewert type II/III, cT1-3N0-1M0) across six tertiary hospitals, who underwent either double-tract reconstruction (DTR) or tubular gastric anastomosis (TGA). Participants were divided into two groups based on the surgical procedure. We conducted a comparative analysis of postoperative outcomes by evaluating electronic medical records, postoperative gastroscopy, 24-hour esophageal pH monitoring, and relevant rating scales.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Gastric Cancer (GC)Double-tract Reconstruction Tubular Gastric Anastomosis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pathologically confirmed gastric adenocarcinoma by biopsy * Carcinoma of the upper gastric body or Siewert type II/III adenocarcinoma of the esophagogastric junction (AEG), with a clinical stage of cT1-3N0-1M0 * Age 18-75 years, with a performance status (PS) score of 0-2 * Candidates for planned surgical resection, eligible for either double-tract reconstruction or tubular gastric anastomosis based on preoperative assessment * No severe dysfunction of vital organs (liver, kidney, heart, lung, or brain), and no severe infection or uncontrolled chronic diseases Exclusion Criteria: * Presence of other malignant tumors or severe chronic diseases (e.g., severe diabetes mellitus, chronic kidney disease, decompensated cirrhosis, etc.) * Preoperative endoscopic diagnosis of Barrett's esophagus * Severe preoperative malnutrition (albumin \<30 g/L, prealbumin \<150 mg/L) * History of prior upper abdominal surgery, gastrointestinal malformation, or psychiatric disorders * Preoperative diagnosis of obstructive motor disorders of the cardia (including achalasia spectrum disorders) * Inability to cooperate with or complete the required postoperative examinations

Outcomes

Primary Outcomes

Incidence of postoperative reflux esophagitis

The diagnosis of reflux esophagitis was based on symptoms, endoscopic findings, and 24-hour esophageal pH monitoring.

Time frame: 6 month after surgery

Severity of reflux esophagitis

According to the diagnostic and grading criteria for reflux esophagitis, patients were classified into four categories: no reflux esophagitis, mild (LA-A/B), moderate (LA-C), and severe (LA-D).

Time frame: 6 month after surgery

Secondary Outcomes

Postoperative nutritional recovery

The body weight change rate at different postoperative time points compared with preoperative levels, along with albumin, prealbumin, and hemoglobin levels, were comprehensively considered in the assessment of postoperative nutritional status.

Time frame: 1 year after surgery