Prospective and Randomized Study Comparing Open vs Laparoscopic Liver Surgery for Colorectal Liver Metastases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
This study evaluates the feasibility of laparoscopic surgery in patients diagnosed with colorectal liver metastases. Half of participants will be operated on by laparoscopic approach and the results obtained will be compared with the results from the other half of patients operated on by open approach.
详细描述
The safety and efficacy of liver surgery in the treatment of colorectal liver metastases are well established for the open approach. It allows good results in terms of complications, disease free survival and overall survival, and for these reasons it has become the gold standard technique in the treatment of colorectal liver metastases.
On the contrary, the role of laparoscopic liver resection in this context is not so clear nowadays. Generally, laparoscopic surgery offers some advantages such as less pain, shorter hospital stay and better aesthetic results. But the use of laparoscopic approach in liver surgery is still discussing: two international consensus conferences have been held and no strong conclusions have been made. Furthermore for colorectal liver metastases no randomized trials, comparing both techniques, have been published until now.
To assess the feasibility of laparoscopic liver resection for colorectal metastases, the investigators propose this trial in which the patients suitable for laparoscopic approach are randomized to open or laparoscopic group
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
- •Patients with colorectal liver metastases;
- •Patients suitable for surgical treatment;
- •Patients eligible for laparoscopy approach.
排除标准
- •Patients with high tumour load: multiples and bilobar colorectal metastases;
- •Patients with big liver metastases or close to major vessels;
- •Patients with oncological contraindications for surgery;
- •Cirrhotic liver
- •Needing for two stage liver resection;
- •Medical or psychiatric condition of the patient that compromises the informed consent authorization;
- •Refusal to participate in the study
研究组 & 干预措施
Laparoscopic group
Liver resection performed by laparoscopic approach
干预措施: Liver resection (Procedure)
Open group
Liver resection performed by open approach
干预措施: Liver resection (Procedure)
结局指标
主要结局
Overall survival
时间窗: 1 year
次要结局
- Hospital stay(Up to 3 months)
- Blood losses(Intraoperative)
- Transfusion(Intraoperative)
- Mortality(90 days)
- Morbidity(90 days)
- Surgical operative time(Intraoperative)
- Time between surgery and adjuvant chemotherapy(Up to 3 months)
研究者
Ricardo Robles Campos
MD, PHD
Hospital Universitario Virgen de la Arrixaca