Status:
RECRUITING
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
Lead Sponsor:
Fujian Cancer Hospital
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 t...
Detailed Description
Early gastric cancer involving the upper third of the stomach or esophagogastric junction is increasingly managed with minimally invasive surgery. The vagus nerve plays an essential role in regulating...
Eligibility Criteria
Inclusion
- Age 18-75 years.
- Histologically confirmed gastric adenocarcinoma or esophagogastric junction adenocarcinoma (papillary, tubular, mucinous, poorly cohesive including signet-ring cell carcinoma, or mixed type).
- Primary tumor located in the upper third of the stomach, or esophagogastric junction cancer with tumor size ≤4 cm.
- Clinical stage cT1bN0M0 without lymph node metastasis.
- BMI \<30 kg/m².
- No history of upper abdominal surgery (except laparoscopic cholecystectomy).
- No prior chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
- ECOG performance status 0-1.
- ASA class I-III.
- Adequate organ function.
- Signed informed consent.
Exclusion
- Pregnancy or breastfeeding.
- Other malignancies within 5 years.
- Active infection requiring systemic therapy or fever ≥38°C preoperatively.
- Severe psychiatric illness.
- Severe respiratory disease.
- Severe hepatic or renal dysfunction.
- Unstable angina or myocardial infarction within 6 months.
- Stroke or intracranial hemorrhage within 6 months.
- Long-term systemic glucocorticoid therapy within 1 month (local use excluded).
- Complications of gastric cancer (bleeding, perforation, obstruction).
- 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.
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT07142122
Start Date
January 1 2025
End Date
January 1 2029
Last Update
August 26 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
420 Fuma Road, Jin'an District, Fuzhou City, Fujian Province
Fuzhou, Fujian, China, 350014