Simultaneous Versus Staged Resection for Initially Resectable Synchronous Rectal Cancer Liver-limited Metastasis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 主要终点
- Severe complication rate after resection of primary and metastatic lesions
研究概览
简要总结
The purpose of this study is to investigate the safety and efficacy of simultaneous liver resections compared to staged hepatectomies of rectal cancer with liver metastasis and to compare the short and long-term survival between the two groups.
详细描述
The optimal surgical strategy for treatment of patients with resectable synchronous rectal liver metastases remains controversial. To answer whether synchronous rectal cancer liver metastases (SLM) should be resected simultaneously with primary cancer or should be delayed, We conducted a randomized, controlled trial to compare the safety and efficacy of simultaneous versus delayed resection of the rectum and liver. Patients with rectal cancer and resectable SLM were randomly assigned to either simultaneous or delayed resection of the metastases. The primary outcome was the rate of major complications (Clavien-Dindo grade≥III) within 30 days following surgery. Secondary outcomes included disease-free and overall survival. A consecutive patients of rectal cancer with liver metastasis from ZhongShan hospital, Fudan university were enrolled and randomly assigned to simultaneous liver resections and staged hepatectomies. Post-operative complications, peri-operative mortality, long-term survival were compared.
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
- •age>=18 and <= 75 years
- •resectable primary rectal tumor
- •remnant liver volume >= 60%
- •without other organ metastasis or peritoneum metastasis
- •without contradiction of cardiac and pulmonary diseases
- •American Society of Anesthesiologists (ASA) class I - II
- •Histologically proved rectal adenocarcinoma
排除标准
- •age > 75 years
- •unresectable primary rectal tumor
- •remnant liver volume < 60%
- •with other organ metastasis or peritoneum metastasis
- •with contradiction of cardiac and pulmonary diseases
- •Tumors assessed as clinical complete response after preoperative radio- or chemoradiotherapy
- •Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery
- •Multiple colorectal tumors or other schedules needing for synchronous colon surgery
- •Co-existent inflammatory bowel disease
- •Pregnancy or lactation
- •Patients received treatment other than preoperative radio- or chemoradiotherapy
结局指标
主要结局
Severe complication rate after resection of primary and metastatic lesions
时间窗: 30 days after surgery
Grade of III-V complication rate according to Clavien-Dindo
次要结局
- Disease free survival(3 years)
- Overall survival(3 years)
- Postoperative hospital stay(30 days after surgery)
- Post-operative mortality(90 days after surgery)
- Complication rate after resection of primary and metastatic lesions(30 days after surgery)
- Cost of hospitalization(2 months)
研究者
Xu jianmin
Deputy director of the department of general surgery
Fudan University