The Inflammatory Response to Stress and Angiogenesis in Liver Resection
April 27, 2017 updated by: University Hospital, Ghent
The Inflammatory Response to Stress and Angiogenesis in Open Versus Laparoscopic Liver Resection for Colorectal Liver Metastases
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).
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 -
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Open Liver Resection
Conventional open liver resection trough subcostal incision
|
liver resections for colorectal liver metastases
|
|
EXPERIMENTAL: Laparoscopic Liver Resection
Pure laparoscopic liver resection without hand assistance
|
liver resections for colorectal liver metastases
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Differences in inflammatory response
Time Frame: Preoperative and postoperative day 1
|
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
Time Frame: One week after surgery
|
Differences in levels of VEGF, HIF-1α, MMP-9 and COX2 in both humoral and normal liver tissue
|
One week after surgery
|
|
Overall Survival
Time Frame: 1-3-5 years
|
From surgery to date of death or last follow up.
Data will be reported in months
|
1-3-5 years
|
|
Recurrence free survival
Time Frame: 1-3-5 years
|
From surgery to recurrence either in the liver or elsewhere.
Data will be reported in months
|
1-3-5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: Medicine (Baltimore). 2016 Mar;95(10):e367e.
- Ueda K, Turner P, Gagner M. Stress response to laparoscopic liver resection. HPB (Oxford). 2004;6(4):247-52. doi: 10.1080/13651820410023987.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 1, 2010
Primary Completion (ACTUAL)
June 30, 2011
Study Completion (ACTUAL)
June 30, 2011
Study Registration Dates
First Submitted
April 20, 2017
First Submitted That Met QC Criteria
April 24, 2017
First Posted (ACTUAL)
April 27, 2017
Study Record Updates
Last Update Posted (ACTUAL)
May 1, 2017
Last Update Submitted That Met QC Criteria
April 27, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006/048
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.