A Randomized Controlled Trial of Needle Ablation With 3D Verification vs Surgical Resection of Colorectal Cancer Liver Metastases
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Local tumor progression
研究概览
简要总结
230 patients with colorectal cancer liver metastases will be randomly assigned to resection or thermal ablation.
详细描述
Rationale: The use of thermal ablation of liver tumors is rapidly increasing. This is despite a lack of high-level evidence of the oncologic efficacy of ablation. Ablation is most often used in cases where resection is not possible, but as the technique has improved it is increasingly used as a substitute for resection. A majority of studies on ablation are hampered by selection bias. Selection bias can only be overcome in a randomized controlled trial.
Primary objective:
To compare rates of local tumor progression within 12 months in patients randomly assigned to thermal ablation or surgical resection of colorectal liver metastases.
Secondary objectives:
- To establish a pipeline for immediate three-dimensional verification of the ablated zone following thermal ablation of liver metastases.
- To compare health related quality of life in patients randomly assigned to thermal ablation or surgical resection of colorectal liver metastases.
- To perform a cost-effectiveness analysis (Cost per quality adjusted life year) of thermal ablation and resection of colorectal liver metastases.
- To compare disease-free and overall survival in in patients randomly assigned to thermal ablation or surgical resection of colorectal liver metastases.
- To evaluate the hemodynamic response to thermal ablation and laparoscopic resection of liver tumors.
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
- Double (Participant, Care Provider)
盲法说明
Masking will be performed by large drapings on wounds and masking of operation notes
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
- •Histologically verified colorectal cancer
- •Colorectal liver metastases (proven or suspected) eligible for radical treatment using EITHER resection OR ablation (not a combination), as decided by the liver MDT meeting at the study center
- •The patient is fit to undergo both resection and ablation of all liver metastases
- •Size of largest lesion up to and including 30 mm
- •In case of solitary metastasis, resection plan includes resection of ≤ 2 anatomical segments.
- •In case of multiple metastases in one continuous resection, resection plan can include ≤ 4 anatomical segments (including hemihepatectomy)
- •≤ 5 tumors to be treated in one procedure
- •Primary tumor either resected (primary first) or with a plan for curative treatment (liver first).
排除标准
- •More than 3 lung metastases where 1 is >10mm, or 1 lung metastasis >15 mm (OR: unresectable lung metastases as decided by the lung MDT meeting)
- •Presence of extrahepatic, extrapulmonary metastases.
- •Surgical indication for removal of enlarged lymph nodes in the hepatic hilum. (Enlarged lymph nodes without indication of removal are not considered an exclusion criterium)
- •Tumor closer than 10 mm to right/left main bile duct
- •Suspected tumor infiltration to adjacent organs
- •Progression (as of RECIST [18]) on 2nd line chemotherapy
- •Previous inclusion in this trial
- •Not eligible for workup according to study criteria
- •Contraindication to contrast enhanced CT scan
- •Manifest liver cirrhosis
- •Pregnancy
- •ECOG performance status ≥3
- •Simultaneous resection of primary tumor or any other concomitant surgical procedure
- •Any other reason why, in the investigator's opinion, the patient should not be included.
研究组 & 干预措施
Surgical resection
Liver resection
干预措施: Surgical resection (Procedure)
Thermal ablation
Thermal ablation (Microwave or radiofrequency)
干预措施: Thermal ablation (Procedure)
结局指标
主要结局
Local tumor progression
时间窗: 12 months
Local tumor progression at site of treatment
次要结局
- Cerebral flow(1 day)
- Overall survival(60 months)
- Overall survival (secondary analysis)(60 months)
- Disease free survival(60 months)
- Postoperative complications(30 days)
- Health related quality of life(12 months)
- Ventilation methods(1 day)
- Inflammatory response(7 days)
- Hemodynamic response(7 days)
- Cost-Effectiveness(12 months)
研究者
Åsmund Avdem Fretland
Consultant HPB surgeon, MD PhD
Oslo University Hospital