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

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

This trial will test whether keeping the celiac branch of the vagus nerve during laparoscopic proximal gastrectomy improves stomach emptying and quality of life for people with early upper stomach or esophagogastric junction cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fujian Cancer Hospital (Government)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT07142122 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults 18–75 years old with histologically confirmed early gastric or esophagogastric junction adenocarcinoma (cT1bN0M0), tumor size ≤4 cm in the upper stomach or EGJ, BMI <30 kg/m², no prior chemo/radiotherapy or major upper abdominal surgery, and good functional status (ECOG 0–1, ASA I–III).

Not a fit: Patients with more advanced disease, prior upper abdominal surgery, significant organ dysfunction, other recent malignancies, pregnancy, or severe comorbidities are unlikely to be eligible or to benefit from this nerve-preserving approach.

Why it matters

Potential benefit: If successful, the approach that preserves the celiac branch could shorten gastric emptying time, reduce reflux symptoms, and improve postoperative quality of life without reducing cancer control.

How similar studies have performed: Smaller observational and surgical series have suggested that vagus-nerve preservation can improve gastric motility and symptoms, but randomized controlled evidence specifically comparing celiac-branch preservation is limited.

Eligibility criteria

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 this trial is running

Fuzhou, Fujian

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

Study contacts

• Study coordinator: Zaisheng Ye, doctoral

Conditions Gastric Cancer; Esophagogastric Junction Adenocarcinoma