Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 70
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of this study is to evaluate the role of splenectomy in potentially curative total gastrectomy for proximal gastric carcinoma in terms of survival benefit and post-operative morbidity.
详细描述
European clinical trials of gastrectomy showed that splenectomy is an important risk factor for post-operative morbidity and mortality. Retrospective comparisons suggested that splenectomy is associated with poor long term survival. However, Japanese studies revealed that 20 - 30 % of patients with non-early carcinoma in the proximal stomach have nodal metastasis in the splenic hilum and therefore, pancreas-preserving splenectomy is part of the standard operation in specialized centers where splenectomy is not considered a risk factor for operative mortality. There have been no prospective randomized trials to evaluate the survival benefit of splenectomy in total gastrectomy for proximal gastric cancer.
Comparison: Total gastrectomy with pancreas-preserving splenectomy versus total gastrectomy without splenectomy
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preoperatively
- •Histologically proven adenocarcinoma
- •T2 or deeper lesion in the upper third of the stomach without involvement of the greater curvature or esophageal invasion, irrespective of the primary tumor location or existence of multiple foci
- •No distant metastasis, not linitis plastica ('Borrmann 4'), not stump carcinoma, no prior treatment for 364 Randomized trial for splenectomy gastric cancer
- •Sufficient organ function
- •Written informed consent.
- •Intra-operatively
- •T2/T3/T4 and N0/N1/N2, no tumor on the greater curvature, no direct invasion of the pancreas or spleen, negative peritoneal lavage cytology
- •No apparent nodal metastasis in the splenic hilum or along the splenic artery
排除标准
- •Liver cirrhosis or portal hypertension
- •Idiopathic thrombocytopenic purpura
- •Severe pulmonary dysfunction
- •Synchronous or metachronous (within 5 years) malignancy.
结局指标
主要结局
Overall survival
时间窗: During the study conduct
次要结局
- Post-operative morbidity(5 years)
- perioperative blood loss(3 days after operation)
- operation time(day of the operation)
研究者
Haruhiko Fukuda
JCOG Data Center
Japan Clinical Oncology Group