Safety Comparison of Total Laparoscopic Proximal Gastrectomy With or Without Preservation of the Celiac Branch of the Vagus Nerve for Early Upper Gastric Cancer: A Randomized Controlled Clinical Trial

Summary

This prospective, single-center, randomized, controlled, non-inferiority clinical trial aims to compare the safety and postoperative quality of life of early upper gastric cancer patients undergoing total laparoscopic proximal gastrectomy (TLPG) with preservation of both the hepatic and celiac branches of the vagus nerve versus preservation of the hepatic branch only. The primary endpoint is gastric emptying half-time of solid food at 6 months after surgery. Secondary outcomes include incidence of reflux esophagitis, quality of life scores (EORTC QLQ-C30/STO22), number and positivity rate of lymph nodes retrieved, and 3-year disease-free survival. The study will provide evidence for optimizing minimally invasive surgical strategies for early upper gastric cancer.

Eligibility

Inclusion Criteria:

1. Age 18-75 years.
2. Histologically confirmed gastric adenocarcinoma or esophagogastric junction adenocarcinoma (papillary, tubular, mucinous, poorly cohesive including signet-ring cell carcinoma, or mixed type).
3. Primary tumor located in the upper third of the stomach, or esophagogastric junction cancer with tumor size ≤4 cm.
4. Clinical stage cT1bN0M0 without lymph node metastasis.
5. BMI \<30 kg/m².
6. No history of upper abdominal surgery (except laparoscopic cholecystectomy).
7. No prior chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
8. ECOG performance status 0-1.
9. ASA class I-III.
10. Adequate organ function.
11. Signed informed consent.

Exclusion Criteria:

1. Pregnancy or breastfeeding.
2. Other malignancies within 5 years.
3. Active infection requiring systemic therapy or fever ≥38°C preoperatively.
4. Severe psychiatric illness.
5. Severe respiratory disease.
6. Severe hepatic or renal dysfunction.
7. Unstable angina or myocardial infarction within 6 months.
8. Stroke or intracranial hemorrhage within 6 months.
9. Long-term systemic glucocorticoid therapy within 1 month (local use excluded).
10. Complications of gastric cancer (bleeding, perforation, obstruction).
11. Participation in another clinical study within 6 months.

Exclusion During Study (Removal Criteria):

R0 resection not achieved, change of procedure to total gastrectomy or PPG, combined surgery for other diseases, severe perioperative complications, emergency surgery required, patient withdrawal of consent, or protocol violation.

Conditions2

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