Clinical trial NCT03131778: The Inflammatory Response to Stress and Angiogenesis in Liver Resection
Official title: The Inflammatory Response to Stress and Angiogenesis in Open Versus Laparoscopic Liver Resection for Colorectal Liver Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cancer
Colorectal Cancer
Metastatic Cancer
Liver Metastases
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 -

Primary outcomes:
measure: Differences in inflammatory response
timeFrame: Preoperative and postoperative day 1
Secondary outcomes:
measure: Differences in tumor stimulating factors
timeFrame: One week after surgery
measure: Overall Survival
timeFrame: 1-3-5 years
measure: Recurrence free survival
timeFrame: 1-3-5 years
Other outcomes:
Locations:
Study officials:
References:
citation: Fretland AA, Sokolov A, Postriganova N, Kazaryan AM, Pischke SE, Nilsson PH, Rognes IN, Bjornbeth BA, Fagerland MW, Mollnes TE, Edwin B. Inflammatory Response After Laparoscopic Versus Open Resection of Colorectal Liver Metastases: Data From the Oslo-CoMet Trial. Medicine (Baltimore). 2015 Oct;94(42):e1786. doi: 10.1097/MD.0000000000001786.
citation: Ueda K, Turner P, Gagner M. Stress response to laparoscopic liver resection. HPB (Oxford). 2004;6(4):247-52. doi: 10.1080/13651820410023987.
citation: Buunen M, Gholghesaei M, Veldkamp R, Meijer DW, Bonjer HJ, Bouvy ND. Stress response to laparoscopic surgery: a review. Surg Endosc. 2004 Jul;18(7):1022-8. doi: 10.1007/s00464-003-9169-7. Epub 2004 May 12.