The Inflammatory Response to Stress and Angiogenesis in Liver Resection

Not Applicable

Completed

• Conditions: Liver Metastases; Liver Cancer; Colorectal Cancer; Metastatic Cancer
• Interventions: Procedure: Liver resection

• Registration Number: NCT03131778
• Lead Sponsor: University Hospital, Ghent

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.

Study Timeline

• Study Start: 2010-04-01
• Primary Completion: 2011-06-30
• Study Completion: 2011-06-30
• Status Verified: 2017-04
• Study First Submitted: 2017-04-20
• Study First Submitted QC: 2017-04-24
• Study First Posted: 2017-04-27
• Last Update Submitted: 2017-04-27
• Last Update Posted: 2017-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open Liver Resection	Liver resection	Conventional open liver resection trough subcostal incision
Laparoscopic Liver Resection	Liver resection	Pure laparoscopic liver resection without hand assistance

Primary Outcome Measures

Name	Time	Method
Differences in inflammatory response	Preoperative and postoperative day 1	Differences in POD 1 levels of IL6 and IL8

Secondary Outcome Measures

Name	Time	Method
Overall Survival	1-3-5 years	From surgery to date of death or last follow up. Data will be reported in months
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
Recurrence free survival	1-3-5 years	From surgery to recurrence either in the liver or elsewhere. Data will be reported in months