Laparoscopic Versus Open Ablation of Liver Malignancies: a Randomized, Controlled Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Complications measured by the comprehensive complication index.
研究概览
简要总结
The purpose of this study is to compare laparoscopic ablation to open ablation of liver malignancies regarding complication rates and ablation response as well as quality of life following the surgery.
详细描述
Liver malignancies is a major cause of cancer-related mortality and the incidence is increasing. Patients with liver malignancies are often left with limited surgical treatment options due to extensive tumor burden or comorbidities. Ablation is a less invasive treatment for these patients that can be performed percutaneously, by laparoscopy or open surgery. Ablation during open surgery has a high potential of complications. Laparoscopic ablation presumably has a lower complication rate than during open surgery, yet still offers some of the same advantages needed for tumors in locations not favorable for percutaneous ablation. This study aims to compare laparoscopic ablation with ablation during open surgery to investigate a treatment option with a supposed lower complication rate and equally treatment effectiveness after one month.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •One or more tumors not amenable to percutaneous ablation, age ≥ 18, signed informed consent, diagnosis of primary liver cancer or liver metastases from any primary tumor, and tumor suitable for ablation as primary treatment.
排除标准
- •Ablation performed in conjunction with resection, patients who cannot cooperate with the study, and patients who do not understand or speak Danish.
研究组 & 干预措施
Open ablation
Laparotomy performed for open ablation of the tumor
干预措施: Open ablation (Procedure)
Laparoscopic ablation
Ablation of the tumor performed by laparoscopic approach
干预措施: Laparoscopic ablation (Procedure)
结局指标
主要结局
Complications measured by the comprehensive complication index.
时间窗: Complications are registered and clavien-dindo graded 30 days after surgery.
Comprehensive Complication Index (CCI) scores compared between open and laparoscopic ablation groups. A higher CCI score represents a larger complication burden.
次要结局
- Quality of Recovery score (QoR)(Before surgery and postoperative day 1, 7 and 30.)
- Tumor ablation completeness.(30 days after surgery.)
- Quality of Life score (QoL)(Before surgery and on postoperative day 30.)
- Overall survival(Up to 90 days after surgery)
研究者
Hans-Christian Pommergaard
MD, DMSc, PhD, Clinical Research Associate Professor
Rigshospitalet, Denmark