Safety Comparison of Total Laparoscopic Proximal Gastrectomy With or Without Preservation of the … (NCT07142122) | Clinical Trial Compass
RecruitingNot Applicable
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
China76 participantsStarted 2025-01-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Pregnancy or breastfeeding.
✕. Other malignancies within 5 years.
What they're measuring
1
Gastric half-emptying time of solid food at 6 months postoperatively (minutes, measured by gastric emptying test)