Associating Liver Partition and Portal Vein Ligation (ALPPS) for Potentially Resectable Liver Metastasis From Colorectal Cancer: Prospective Evaluation of the Early Two-stage Hepatectomy by the Simon's Methods
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- number of complete surgical procedure
研究概览
简要总结
The aim of this study is evaluate the feasibility of early two-stage hepatectomy in patients with liver metastasis from colorectal cancer.
详细描述
In France, each year around 36,000 new cases of colorectal cancers are registered responsible in 16,000 deaths because of liver metastasis.
In case of bilobar metastasis, classic two-stage hepatectomy with portal embolization could be performed.
An alternative to the classic surgery, early two stage hepatectomy, could be proposed to simplify the patient's management and to improve the resectability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •potentially resectable liver metastasis from colorectal cancer
- •portal embolisation required
- •older than 18 years old
排除标准
- •synchronous surgery on the colon or the rectum
- •extra hepatic metastasis
- •history of hepatectomy
- •pregnancy or breastfeeding
研究组 & 干预措施
two stage hepatectomy
the two stage hepatectomy is defined as a two step procedure: first step: hepatotomy with ligature of the right branch of the portal vein second step (one week after the first step): right hepatectomy
干预措施: two stage hepatectomy (Procedure)
结局指标
主要结局
number of complete surgical procedure
时间窗: postoperative week 4
the number of complete surgical procedure is defined as the number of patients in whom the two stage hepatectomy is complete.
次要结局
- overall mortality(one year after the two stage hepatectomy)
- overall morbidity(postoperative day 30)
- preoperative liver volumetry(one week prior to the surgery)
- quality of life(the day before the first stage surgery and the day before the second stage surgery)
- number of patient with hepatocellular insufficiency(postoperative day 30)