Laparoscopic proximal gastrectomy with or without preserving the celiac branch of the vagus nerve for early upper stomach cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center, randomized, non-inferiority trial comparing two nerve-preserving approaches during total laparoscopic proximal gastrectomy: preservation of both the hepatic and celiac branches of the vagus nerve versus preservation of the hepatic branch only. Eligible patients with cT1bN0M0 tumors ≤4 cm in the upper third of the stomach or esophagogastric junction will be randomized 1:1 to the two surgical approaches, and both groups will receive double-tract reconstruction. The primary outcome is gastric emptying half-time of solid food at six months after surgery, with secondary endpoints including reflux esophagitis rates, EORTC QLQ-C30/STO22 quality-of-life scores, lymph node yield and positivity, and three-year disease-free survival. Standard perioperative care and statistical methods will be used to compare safety, functional recovery, and oncologic outcomes between the groups.

Why it matters

Who can join: the full rules

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.

Where it's running

• 420 Fuma Road, Jin'an District, Fuzhou City, Fujian Province
  Fuzhou, Fujian, China Recruiting

Study contacts

• Study coordinator: Zaisheng Ye, doctoral
• Email: flyingengel@sina.com
• Phone: +86 591 13950203076

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.