Colorectal Cancer, Liver Cancer, Liver Metastases, Metastatic Cancer
Conditions
Brief summary
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
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.
Interventions
PROCEDURELiver resection
liver resections for colorectal liver metastases
Sponsors
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 18-80 years old 2. Patients with colorectal liver metastases 3. Colorectal liver metastases ≤10 cm in size -
Exclusion criteria
1. Patients not fit for laparoscopic surgery due to comorbidities 2. Patients with tumors close or infiltrating the major vessels -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in inflammatory response | Preoperative and postoperative day 1 | Differences in POD 1 levels of IL6 and IL8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in tumor stimulating factors | One week after surgery | Differences in levels of VEGF, HIF-1α, MMP-9 and COX2 in both humoral and normal liver tissue |
| Overall Survival | 1-3-5 years | From surgery to date of death or last follow up. Data will be reported in months |
| Recurrence free survival | 1-3-5 years | From surgery to recurrence either in the liver or elsewhere. Data will be reported in months |
Outcome results
None listed