Prospective Randomized Controlled Trial on Clinical Application Value of Modified Delta-shaped Gastroduodenostomy in Totally Laparoscopic Surgery and Billroth-I Anastomosis in Laparoscopy-assisted Surgery for Distal Gastric Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- 3-year disease free survival rate
研究概览
简要总结
The purpose of this study is to explore the clinical application value of modified delta-shaped gastroduodenostomy in totally laparoscopic surgery for distal gastric cancer.
详细描述
A prospective randomized comparison of the modified delta-shaped gastroduodenostomy in totally laparoscopic surgery and Billroth-I anastomosis in laparoscopy-assisted surgery for distal gastric cancer will be performed, to evaluate the clinical value and provide theoretical basis and clinical experience for the extensive application of the modified technique. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.
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 from 18 to 75 years (including 18 and 75 years old)
- •Primary distal gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- •cT1-4a, N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
- •Expected curative resection through distal subtotal gastrectomy with D2 lymphadenectomy
- •Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
- •American Society of Anesthesiology score (ASA) class I, II, or III
- •Written informed consent
排除标准
- •Women during pregnancy or breast-feeding
- •Severe mental disorder
- •History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- •History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
- •Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
- •History of other malignant disease within past five years
- •History of previous neoadjuvant chemotherapy or radiotherapy
- •History of unstable angina or myocardial infarction within past six months
- •History of cerebrovascular accident within past six months
- •History of continuous systematic administration of corticosteroids within one month
- •Requirement of simultaneous surgery for other disease
- •Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- •FEV1<50% of predicted values
结局指标
主要结局
3-year disease free survival rate
时间窗: 36 months
次要结局
- Inflammatory and immune response(7 days)
- Postoperative recovery course(10 days)
- Morbidity and mortality(30 days;36 months)
- Postoperative nutritional status and quality of life(12 months)
- 3-year overall survival rate(36 months)
- 3-year recurrence pattern(36 months)
- Intraoperative situation(1 day)
研究者
Chang-Ming Huang, Prof.
Fujian Medical University Union Hospital
Fujian Medical University