Laparoscopy-assisted Pylorus-vagus Nerve Preserving Gastrectomy in the Treatment of Early Gastric Cancer: Clinical Outcomes of a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Progression-free Survival
研究概览
简要总结
The safety and efficacy of Laparoscopy-assisted Pylorus-preserving Gastrectomy (LAPPG) for the treatment of early gastric cancer (EGC) remain controversial. The investigators conducted a randomized controlled trial to compare LAPPG and laparoscopic distal gastrectomy with D2 lymph node dissections for EGC.
详细描述
During the procedure, the distal part of the stomach is resected, but a pyloric cuff 2-3 cm wide is preserved. The right gastric artery and the infrapyloric artery are preserved to maintain the blood supply to the pyloric cuff. In addition, the hepatic and pyloric branches of the vagal nerves are preserved to maintain pyloric function. The celiac branch of the posterior vagal trunk is sometimes preserved. All regional nodes except the suprapyloric nodes (No. 5) should be dissected as in the standard D2 procedure. However, there are technical challenges associated with completing all of these procedures.The five-year survival rate after PPG with modified D2 lymph node dissection ranges from 95% to 98%. This rate is comparable to the five-year survival rate after gastric resection for EGC, which ranges from 90% to 98%. In terms of oncologic safety, PPG seems reasonably safe for EGC when the accuracy of preoperative diagnosis can be assured
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
- 是
入选标准
- •Age older than 18 and younger than 75 years
- •Primary gastric adenocarcinoma confirmed pathologically by endoscopic biopsy
- •cT1-2N0-3M0 at preoperative evaluation according to AJCC Cancer Staging Manual, 7th Edition
- •Expected curative resection via distal subtotal gastrectomy with D2 lymphadenectomy
- •Written informed consent
排除标准
- •Pregnant or breast-feeding women
- •Severe mental disorder
- •Previous upper abdominal surgery (except laparoscopic cholecystectomy)
- •Previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection
- •Other malignant disease within the past 5 years
- •Previous neoadjuvant chemotherapy or radiotherapy
- •Unstable angina, myocardial infarction, or cerebrovascular accident within the past 6 months
- •Continuous systematic administration of corticosteroids within 1 month before the study
- •Requirement of simultaneous surgery for other diseases
- •Emergency surgery due to a complication (bleeding, obstruction, or perforation) caused by gastric cancer
结局指标
主要结局
Progression-free Survival
时间窗: 3 years
It is the time that passes from the first date after treatment and the date on which gastric cancer progresses, as demonstrated by laboratory testing, radiologic testing, or clinically.
次要结局
- Postoperative complications(30 days)
- Postoperative mortality(30 days)
- 3 years overall survival(3 years)