About this trial
Gastric cancer ranks as the fifth most common malignancy worldwide and the fourth leading cause of cancer-related deaths. In China, its incidence and mortality rank third among all cancers. While the global incidence of gastric cancer is declining, proximal gastric cancer and adenocarcinoma of the esophagogastric junction (AEG) are on the rise. Due to the unique characteristics of AEG, there is no standardized treatment consensus, making the selection of an optimal surgical approach and reconstruction method crucial for improving patient outcomes.
For early-stage proximal gastric cancer and AEG, total gastrectomy (TG) and proximal gastrectomy (PG) are common surgical options. PG, increasingly favored for its function-preserving benefits, has been shown to be a safe and effective alternative to TG. While TG effectively removes lymph nodes and reduces reflux risk, it leads to permanent loss of gastric function and nutritional deficiencies. PG better preserves gastrointestinal function but is limited by the risk of reflux esophagitis, highlighting the need for improved reconstruction techniques.
Several reconstruction methods exist after PG, including esophagogastric anastomosis, jejunal interposition, double-tract reconstruction (DTR), double-flap technique (DFT), and tubular gastric anastomosis, each with varying efficacy in preventing reflux. Studies suggest that DTR reduces reflux and improves quality of life compared to esophagogastric anastomosis, while DFT, first introduced in 1998, has gained popularity for its advantages in maintaining nutrition and minimizing reflux. Additionally, tubular gastric anastomosis, which constructs a narrow gastric tube to facilitate tension-free anastomosis, has shown potential benefits for AEG patients.
Most existing studies on laparoscopic or robot-assisted reconstruction techniques for proximal gastric cancer are retrospective, lacking high-quality prospective evidence. Furthermore, comparative data on their anti-reflux efficacy and postoperative quality of life remains l
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age from over 18 to under 75 years.
Preoperative gastroscopic pathological biopsy was performed, and histologically confirmed as carcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, poorly differentiated adenocarcinoma, mixed adenocarcinoma, etc.) or adenoma.
Diagnosed with upper gastric cancer (T1N0M0, T1N1M0, or T2N0M0) or esophagogastric junction cancer with a diameter ≤4 cm based on the 8th edition of the AJCC staging system, as confirmed by CT, MRI, endoscopic ultrasound, and pathology.
Undergoing proximal gastrectomy with D2 lymphadenectomy is expected to achieve curative resection, with the remaining gastric volume required to be at least half of the pre-resection volume.
Disqualifiers
Patients who have received preoperative radiotherapy, chemotherapy, targeted therapy, or immunotherapy.
Presence of multiple malignant tumors in the stomach.
History of upper abdominal surgery, except for laparoscopic cholecystectomy.
History of gastric surgery, except for endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR) for gastric cancer.
Trial population
Patients with upper gastric cancer (T1N0M0, T1N1M0, or T2N0M0 according to the AJCC 8th edition) and esophageal junction cancer (≤4cm in diameter).
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Incidence of reflux esophagitis
The proportion of patients with reflux esophagitis diagnosed by digestive endoscopy (LA classification), barium meal (barium meal) and (GerdQ scale).
Secondary outcomes
Incidence of Postoperative complications
The total number of patients who underwent surgical treatment was used as the denominator, and the number of patients with any postoperative complication was used as the numerator to calculate the incidence percentage.
Postoperative mortality
The total number of patients who underwent surgical treatment was used as the denominator, and the number of patients who died after surgery was used as the numerator to calculate the incidence percentage.
Body weight change
Body weight will be monitored during follow-up after surgery.
Long-term postoperative quality of life
Quality of life was assessed by EORTC QLQ-STO22 questionnaires.
Sponsors and contacts
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