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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Gastric half-emptying time of solid food at 6 months postoperatively (minutes, measured by gastric emptying test)
研究概览
简要总结
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.
详细描述
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 gastric motility and postoperative physiological recovery. Preservation of the hepatic branch is widely accepted, while the role of preserving the celiac branch remains controversial. This trial is designed to evaluate whether preservation of the celiac branch during TLPG improves gastric emptying and postoperative quality of life without compromising oncological safety. Eligible patients (cT1bN0M0, tumor size ≤4 cm, no prior chemotherapy/radiotherapy) will be randomized into two groups: Group A (hepatic and celiac branches preserved) and Group B (hepatic branch preserved only). Both groups undergo double-tract reconstruction. The study will enroll 76 patients (38 per group) with sufficient statistical power. Outcomes will be analyzed using standard statistical methods, and the findings are expected to provide evidence for refined vagus-nerve-preserving surgery in early gastric cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •ASA class I-III.
- •Adequate organ function.
- •Signed informed consent.
排除标准
- •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.
研究组 & 干预措施
Experimental Arm (Group A)
Total laparoscopic proximal gastrectomy with preservation of hepatic and celiac branches of the vagus nerve. Reconstruction by double-tract anastomosis.
干预措施: Total laparoscopic proximal gastrectomy with preservation of both the hepatic and celiac branches of the vagus nerve, followed by double-tract reconstruction. (Procedure)
Active Comparator Arm (Group B)
Procedure: Total laparoscopic proximal gastrectomy with preservation of hepatic branch but without preservation of the celiac branch of the vagus nerve. Reconstruction by double-tract anastomosis.
干预措施: Total laparoscopic proximal gastrectomy with preservation of the hepatic branch of the vagus nerve but deliberate resection of the celiac branch, followed by double-tract reconstruction. (Procedure)
结局指标
主要结局
Gastric half-emptying time of solid food at 6 months postoperatively (minutes, measured by gastric emptying test)
时间窗: 6 months post-operation
次要结局
- EORTC QLQ-C30/STO22 Scores(1,3,6,12,24 months)
- Reflux Esophagitis (LA Classification)(1,3,6,12,24 months)
- 3-Year Disease-Free Survival(36 months)
- Lymph Node Yield/Positivity Rate(Intraoperative)