NCT07142122Recruiting
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
Source: ClinicalTrials.gov · Last updated 26 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 76 (estimated)
- First submitted
- 19 Aug 2025
- Start date
- 1 Jan 2025
- Primary completion date
- 1 Jan 2029
- Lead sponsor
- Fujian Cancer Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07142122
What you commit to
- Study type: Interventional
- Planned participants: 76
- From 1 Jan 2025 to the primary completion date, 1 Jan 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Long-term systemic glucocorticoid therapy within 1 month (local use excluded).
Other illness
- Other malignancies within 5 years.
- Active infection requiring systemic therapy or fever ≥38°C preoperatively.
- Severe psychiatric illness.
- Severe respiratory disease.
- Unstable angina or myocardial infarction within 6 months.
- Stroke or intracranial hemorrhage within 6 months.
- 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.
Other
- Pregnancy or breastfeeding.
- Severe hepatic or renal dysfunction.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 420 Fuma Road, Jin'an District, Fuzhou City, Fujian Province Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.