The Inflammatory Response to Stress and Angiogenesis in Open Versus Laparoscopic Liver Resection for Colorectal Liver Metastases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Differences in inflammatory response
研究概览
简要总结
Patients with resectable liver metastases of colorectal origin will be assigned to laparoscopic liver resection or conventional open liver surgery.
Blood samples will be drawn preoperatively and 24 hours after resection. Determination of Interleukin-6 (IL-6) and IL-8 will be done to assess the stress response between open and laparoscopic liver resection (Elisa test).
The Messenger Ribonucleic Acid (mRNA) of inflammation related factors (cyclooxygenase-2 (COX-2) and Matrix metalloproteinase (MMP-9)), angiogenesis related factor (vascular endothelial growth factor (VEGF) and hypoxia induced factor-1 (HIF-1)) in tumor tissue and normal liver parenchyma will be detected by real-time real time-Polymerase Chain Reaction (RT-PCR).
详细描述
According to the null hypothesis, no difference in the IL6 postoperative value, between the two groups would be expected. To calculate sample size, a IL6 postoperative value of 100±40 pg/mL in the laparoscopic group and 60±40 mL/m pg/mL in the open group was hypothesized. Considering a two-sided α=0.05 and β=0.1, the minimal sample size required to achieve statistical significance was 17 subjects in both groups in a 1:1 randomization. Laparoscopic group was increased by 20% of patients considering a conversion rate of 20% accordingly. Randomization will be performed using computer-generated random numbers the day before operation and stopped when 20 patients per group will be reached.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years old
- •Patients with colorectal liver metastases
- •Colorectal liver metastases ≤10 cm in size -
排除标准
- •Patients not fit for laparoscopic surgery due to comorbidities
- •Patients with tumors close or infiltrating the major vessels -
结局指标
主要结局
Differences in inflammatory response
时间窗: Preoperative and postoperative day 1
Differences in POD 1 levels of IL6 and IL8
次要结局
- Overall Survival(1-3-5 years)
- Differences in tumor stimulating factors(One week after surgery)
- Recurrence free survival(1-3-5 years)