Prospective Randomized Comparison of Resection and Microwave Ablation for Resectable Colorectal Cancer Liver Metastases
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Local disease control at the site of intervention
研究概览
简要总结
This single-center, prospective, randomized clinical trial is designed to compare the clinical characteristics and outcomes of hepatic resection and microwave ablation (MWA) to determine the optimal operative intervention for the local treatment of resectable colorectal cancer liver metastases. The primary aim of this study is to test the following hypothesis: 2-year local disease control is equivalent between patients receiving the experimental therapy (MWA) and patients receiving the standard therapy (hepatic resection) as treatment for colorectal cancer liver metastases determined to be resectable by radiographic imaging. Secondarily, the investigators expect that 2-year intrahepatic (regional) and metastatic disease recurrence rates are equivalent between the two treatment arms in this study.
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
- Single (Outcomes Assessor)
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
- •Diagnosis of adenocarcinoma of the colon or rectum (diagnosed at the time of colon or rectal resection or on endoscopic biopsy) with liver metastases (by liver biopsy or by history of biopsy-proven colon/rectal cancer with characteristic imaging findings):
- •Imaging showing typical features of colorectal cancer liver metastasis;
- •Cytologic/histologic diagnosis of colorectal cancer or colorectal cancer liver metastasis.
- •No more than 3 hepatic metastatic lesions noted on preoperative imaging
- •No lesion greater than 5 cm in maximal dimension
- •Adequate clinical condition to undergo laparoscopic or robot-assisted laparoscopic liver resection or microwave ablation as treatment for colorectal cancer liver metastases
- •Willing and able to give informed consent
排除标准
- •Radiologic (computed tomography or magnetic resonance imaging) evidence of invasion into major portal/hepatic venous branches and no extrahepatic metastases
- •Evidence of recurrent disease adjacent to a previous ablation or resection site
- •Severe renal dysfunction (creatinine clearance of <40 mL/min)
- •Pregnant or nursing women
结局指标
主要结局
Local disease control at the site of intervention
时间窗: 2 years
Local disease control is measured from time of randomization and is defined as the absence of local recurrence of metastatic adenocarcinoma of the colon or rectum as determined by diagnostic imaging.
次要结局
- Intrahepatic disease-free survival(1, 2, 3, 5 years)
- Postoperative morbidity(1 month and 3 months)
- Overall survival(1, 2, 3, 5 years)
- Postoperative mortality(1 month and 3 months)