Prospective Randomized Controlled Multicenter Clinical Trial for Comparison of Long-term Outcomes Between Laparoscopy-assisted and Open Distal Subtotal Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 1,056
- 试验地点
- 1
- 主要终点
- 3-year disease free survival rate
研究概览
简要总结
evaluate the long-term efficacy and safety of oncology between D2 laparoscopic approach distal gastric resection (distal gastrectomy, D2 lymph node dissection) with the current standard surgical treatment model D2 open approach distal gastric resection (distal gastrectomy, D2 lymphadenectomy).
详细描述
Study type：Interventional Study phase：Phase III Objectives of Study：to evaluate the long-term efficacy and safety of oncology between D2 laparoscopic approach distal gastric resection (distal gastrectomy, D2 lymph node dissection) with the current standard surgical treatment model D2 open approach distal gastric resection (distal gastrectomy, D2 lymphadenectomy).
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
- •18 years ~ 75 years;
- •the primary adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, poorly differentiated adenocarcinoma);
- •clinical stage T2-4a, N0-3, M0 (according to AJCC-7th TNM staging);
- •to perform distal gastrectomy, D2 lymph node dissection surgical can obtain R0 resection (multiple primary cancers also apply)
- •ECOG performance status 0/1;
- •ASA score I-III;
- •patient informed consent.
排除标准
- •pregnant or lactating women;
- •serious mental illness;
- •upper abdominal surgery (except laparoscopic cholecystectomy );
- •gastric surgery (including for gastric ESD / EMR);
- •imaging examinations showed regional integration lymph nodes (maximum diameter ≥ 3cm)
- •other malignant diseases in 5 years;
- •implemented or recommended neoadjuvant therapy in patients with gastric cancer ;
- •have unstable angina or myocardial infarction within six months; (9) have cerebral infarction or cerebral hemorrhage within 6 months; (10) sustained systemic glucocorticoid treatment history within 1 month; (11) have other diseases needed operative treatment at the same time; (12) complications (bleeding, perforation, obstruction) required emergency surgery; (13) Pulmonary function tests FEV1 <50% of predicted value.
结局指标
主要结局
3-year disease free survival rate
时间窗: three years
次要结局
未报告次要终点
研究者
Cai Kailin
Associate chief physician of gastrointestinal surgery
Huazhong University of Science and Technology