The Inflammatory Response to Stress and Angiogenesis in Liver Resection

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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The Inflammatory Response to Stress and Angiogenesis in Open Versus Laparoscopic Liver Resection for Colorectal Liver Metastases

Conditions
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Liver Cancer, Colorectal Cancer, Metastatic Cancer, Liver Metastases

Intervention / Treatment
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* Procedure: Liver resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-80 years old Patients with colorectal liver metastases Colorectal liver metastases ≤10 cm in size - Exclusion Criteria: Patients not fit for laparoscopic surgery due to comorbidities Patients with tumors close or infiltrating the major vessels -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Open Liver Resection<br>Conventional open liver resection trough subcostal incision | Procedure: Liver resection<br>* liver resections for colorectal liver metastases<br>|
| Experimental: Laparoscopic Liver Resection<br>Pure laparoscopic liver resection without hand assistance | Procedure: Liver resection<br>* liver resections for colorectal liver metastases<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in inflammatory response | Differences in POD 1 levels of IL6 and IL8 | Preoperative and postoperative day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in tumor stimulating factors | Differences in levels of VEGF, HIF-1α, MMP-9 and COX2 in both humoral and normal liver tissue | One week after surgery | 
| Overall Survival | From surgery to date of death or last follow up. Data will be reported in months | 1-3-5 years | 
| Recurrence free survival | From surgery to recurrence either in the liver or elsewhere. Data will be reported in months | 1-3-5 years |