Prospective Randomized Study Comparing the Morbidity and Mortality After Liver Resection for Synchronous Colorectal Cancer Metastases When Performed Either During or 12 to 14 Weeks After the Primary Resection
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 105
- 试验地点
- 26
- 主要终点
- Rate of patients with at least one postoperative severe complication within 60 days after each surgery
研究概览
简要总结
The surgical strategy for the treatment of synchronous colorectal cancer liver metastases has not still been defined. The purpose of this study is to compare two treatment strategies in which liver resection is performed either during, or 12 to 14 weeks after the primary resection. Endpoints include the rate of severe complications and survival.
详细描述
In France, 35 000 colorectal cancers are diagnosed each year, 15 to 25% of which with hepatic metastases. It is nowadays admitted that the complete resection of these hepatic metastases represents the only treatment that has been shown to increase survival. The aim of this study is to evaluate the efficacy/safety ratio of the liver surgery when performed simultaneously or at distance of the primitive tumour ablation. Patients are randomized to undergo liver surgery either during, or 12 to 14 weeks after the primary resection. The primary endpoint is the rate of patients with at least one severe complication within 60 days after surgery. Secondary endpoints evaluate long-term clinical outcomes, in particular recurrence-free survival.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female adults over 18 years old
- •At least one adenocarcinoma of colon and/or rectum, histologically proven.
- •No local complication at the time of surgery (no occlusion, no sub-occlusion, no massive hemorrhage, no abscesses or local invasion)
- •At least one hepatic metastasis which R0 resection is possible through a conventional simple resection
- •Informed written consent.
- •Non inclusion criteria:
- •Heart, Respiratory or Renal failure
- •Physical or psychological dependence
- •Chronic liver disease
- •Extra-hepatic metastases
排除标准
- •(at time of surgery)
- •Localized or diffuse peritoneal carcinomatosis
- •Non resectable lymph node metastases
- •Colorectal or hepatic tumour extension towards abdominal wall and/or adjacent organ making liver R0 resection impossible immediately
- •Other hepatic lesions diagnosed with ultrasound making liver R0 resection impossible immediately
研究组 & 干预措施
1
Simultaneous surgery of colorectal cancer and synchronous liver metastases
干预措施: Simultaneous surgery (Procedure)
2
Sequential surgeries of colorectal cancer and synchronous liver metastases
干预措施: Sequential surgery (Procedure)
结局指标
主要结局
Rate of patients with at least one postoperative severe complication within 60 days after each surgery
时间窗: 60 days after each surgery
次要结局
- Rate of unachieved hepatic resection(Day of the hepatic surgery)
- Rate and number of severe general, digestive or hepatic complications(2 years after the first surgery)
- Death rate during hospitalization or within 60 days after each surgery(60 days after each surgery)
- Global survival distribution and 2 years global survival rate(2 years after the first surgery)
- Recurrence-free survival distribution and 2 years recurrence-free survival rate(2 years)
- Two years recurrence rate(2 years)