A Multicenter Randomized Phase II Clinical Trial of Laparoscopy Assisted Versus Open Distal Gastrectomy With D2 Lymph Node Dissection for Advanced Gastric Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 204
- 试验地点
- 14
- 主要终点
- noncompliance rate
研究概览
简要总结
The purpose of this study is to evaluate the oncological feasibility of laparoscopy-assisted distal gastrectomy with D2 lymph node dissection for advanced gastric cancer.
详细描述
To test oncological feasibility, compliance of nodal dissection was selected as a primary end point. When there are more than two missing nodal station(no lymph nodes in dissected area), it is defined as a non-compliant nodal dissection. Other secondary outcomes will be supplementary to evaluate feasibility of D2 dissection.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically proven primary gastric adenocarcinoma
- •T2 or T3 or T4a, N0 or N1 or N2 or N3a (AJCC 7th), which is assessed by computed tomography (CT) scan - mid 1/3 or low 1/3 location
- •No evidence of other distant metastasis
- •not stump carcinoma,(vi) aged 20-80 year old
- •performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
- •no prior treatment of chemotherapy or radiation therapy against any other malignancies, and no prior treatment for gastric cancer including endoscopic mucosal resection
- •adequate organ functions defined as indicated below:
- •WBC 3000/mm3, WBC 12 000/mm3
- •Hb 8.0 g/dl without any transfusion 2 weeks before enrollment
- •Plt 100 000/mm3
- •AST 100 IU/l
- •ALT 100 IU/l
- •T.Bil 2.0 mg/dl
- •written informed consent
排除标准
- •active double cancer (synchronous double cancer and metachronous double cancer within five disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer)
- •pregnant or breast-feeding women
- •severe mental disorder
- •systemic administration of corticosteroids
- •unstable angina or myocardial infarction within 6 months of the trial
- •unstable hypertension
- •severe respiratory disease requiring continuous oxygen therapy
- •previous upper abdominal surgery except laparoscopic cholecystectomy
结局指标
主要结局
noncompliance rate
时间窗: postoperative 1 week
A Case will be designated as "noncompliant" when there are more than one missing lymph node station according to the guidelines of "The Japanese Research Society for Gastric Cancer" (JRSGC) lymph node grouping
次要结局
- Postoperative surgical complications(postoperative 1 day, 1 week, 1 months, 3 months, 6 months, 12 months)
- operating time(operation day)
- time to first flatus(postoperative 1 week)
- distal resection margin,(postoperative 1 week)
- unanimity rate of 3 randomly assigned laparoscopic gastric cancer surgeons(postoperative 3 months)
- number of retrieved lymph nodes(postoperative 1 week)
- number of retrieved lymph nodes at each stations(postoperative 1 week)
- proximal resection margin(postoperative 1 week)
- 3-year disease free survival(postoperative 3 years)
研究者
Young-Woo Kim
Head of Department of Gastric Cancer Surgery
National Cancer Center, Korea