Microwave Ablation Versus Resection for Resectable Colorectal Liver Metastases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 3
- 主要终点
- Overall survival
研究概览
简要总结
This study aims to prove that a strategy of first line local ablation of colorectal liver metastases with microwaves is not inferior to liver resections in terms of survival rates at three years with secondary endpoints being survival at five and ten years, interventional complication rates, length of stay, ablation precision measurements, need for further interventions and health-economic analysis.
A cohort of 100 patients treated with CT guided microwave ablation of 1-5 metastases <31mm in size will be followed and compared with propensity scored matched controls from the Swedish liver surgery registry - Sweliv.
The study is a multi-institutional effort by the Hepato Pancreatico Biliary (HPB) units in Stockholm Sweden, Bern Switzerland and Groningen in the Netherlands.
详细描述
BACKGROUND
Surgery Surgical resection of operable colorectal liver metastases is the current gold standard. With advancement in surgical techniques and technology the 3-year survival rate for this group of patients is now in the range of 60% [1] where the survival without resection is virtually non-existent. Palliative chemotherapy can prolong survival for 12-24 months, but very rarely much more than this [2].
Operability is decided by the general health condition of the patient, the global liver function and tumour associated factors like the number, size and distribution of the liver metastases.
It is uncommon to disqualify surgery because of the general health of the patient, but is sometimes a reality with advanced age and severe comorbidities.
The combination of size, number and distribution of liver metastases determines the extent of the resection and thereby the size of the liver that will remain after surgery. This is a critical factor as postoperative liver failure is often fatal. With an otherwise healthy liver, approximately 75% of the parenchyma can be resected and the remaining 25% will within a year has regenerated so that the total liver volume is around 80-90% of the original liver [3].
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with 1-5 colorectal liver metastases
- •No metastases larger than 30 mm in diameter
- •All lesions amenable to CT-guided percutaneous microwave ablation
- •Patient also resectable
- •Patients so evaluated at the multidisciplinary tumor board meeting
排除标准
- •Kidney failure excluding the use of iv contrast medium
- •Lack of informed consent
- •Logistic reasons where patient does not live in the region of the treatment centre
结局指标
主要结局
Overall survival
时间窗: 3 years
次要结局
- Need for further liver specific treatment as assessed by number of sessions with ablation or resections(5 years)
- Local recurrence rates(3 years)
- Overall cost of treatment as measured in euros(3 years)
- Accuracy of placement of ablative device measured as mm from needle target location(intraoperative)
- Complications to treatment(1 year)
- Disease free survival(3 years)
- Overall survival(10 years)
- Analysis of ablation volumes measured as length and radius of ovoid ablation zone.(1-28 days post intervention)
研究者
Jacob Freedman
Prof
Karolinska Institutet