NCT05268549Unknown不适用
Independent Risk Factors Analysis and Model Construction For Recurrence After Radiofrequency/Microwave Ablation of Colorectal Cancer With Liver Metastases: a Retrospective, Multicenter Trial
The Central Hospital of Lishui City0 个研究点目标入组 80 人开始时间: 2022年3月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 主要终点
- The first recurrence of colorectal cancer with liver metastasis (CRLM) after radiofrequency/microwave ablation, assessed up to 18 months
研究概览
简要总结
This study is a retrospective, multicenter clinical study. The main objective is to analyze the risk factors affecting the recurrence of colorectal cancer patients with liver metastases who received radiofrequency/microwave ablation. Finally, we will construct a recurrence risk prediction model based on the risk factors and validated the model.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Age：older than 18 years；
- •Patients with a single tumor diameter ≤5cm, no more than 3 tumor nodules, and the largest tumor diameter ≤3cm；
- •Absence of vessel, bile duct and adjacent organ invasion and distant metastasis;
- •The primary tumor of colorectal cancer has been resected, the liver metastases cannot be resected or the patient is unwilling to undergo surgery (clinical or pathological confirmation);
- •Normal coagulation status and liver function child-pugh A or B;
- •Liver metastases have not received other antitumor therapy after radiofrequency/microwave therapy (before disease progression);
- •Routine laboratory tests were performed before the first RF/microwave treatment;
- •Follow up for more than 12 months;
- •Obtained free informed consent.
排除标准
- •Large tumor, or diffuse intrahepatic metastasis;
- •Accompanied by vascular tumor thrombus or invasion of adjacent organs;
- •The primary tumor of colorectal cancer has not been resected, with extrahepatic metastasis;
- •Uncorrectable coagulation dysfunction and severe blood abnormalities, those with severe bleeding tendency;
- •Intractable massive ascites, cachexia;
- •Active infection, especially inflammation of the biliary system;
- •Severe liver, kidney, heart, lung, brain and other major organ failure;
- •Patients with impaired consciousness or unable to cooperate with treatment;
- •Missing follow-up data.
结局指标
主要结局
The first recurrence of colorectal cancer with liver metastasis (CRLM) after radiofrequency/microwave ablation, assessed up to 18 months
时间窗: Time from enrollment to disease recurrence, assessed up to 18 months
The first recurrence of colorectal cancer with liver metastasis (CRLM) after radiofrequency/microwave ablation, assessed up to 18 months
次要结局
- Patients with colorectal cancer with liver metastases (CRLM) developed new metastases after radiofrequency/microwave ablation,assessed up to 18 months(Time from enrollment to developed new metastases, assessed up to 18 months)
研究者
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