The Inflammatory Response to Stress and Angiogenesis in Liver Resection
Primary Purpose
Liver Cancer, Colorectal Cancer, Metastatic Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Liver resection
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cancer
Eligibility Criteria
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 -
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Open Liver Resection
Laparoscopic Liver Resection
Arm Description
Conventional open liver resection trough subcostal incision
Pure laparoscopic liver resection without hand assistance
Outcomes
Primary Outcome Measures
Differences in inflammatory response
Differences in POD 1 levels of IL6 and IL8
Secondary Outcome Measures
Differences in tumor stimulating factors
Differences in levels of VEGF, HIF-1α, MMP-9 and COX2 in both humoral and normal liver tissue
Overall Survival
From surgery to date of death or last follow up. Data will be reported in months
Recurrence free survival
From surgery to recurrence either in the liver or elsewhere. Data will be reported in months
Full Information
NCT ID
NCT03131778
First Posted
April 20, 2017
Last Updated
April 27, 2017
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT03131778
Brief Title
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
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 1, 2010 (Actual)
Primary Completion Date
June 30, 2011 (Actual)
Study Completion Date
June 30, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer, Colorectal Cancer, Metastatic Cancer, Liver Metastases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open Liver Resection
Arm Type
Active Comparator
Arm Description
Conventional open liver resection trough subcostal incision
Arm Title
Laparoscopic Liver Resection
Arm Type
Experimental
Arm Description
Pure laparoscopic liver resection without hand assistance
Intervention Type
Procedure
Intervention Name(s)
Liver resection
Intervention Description
liver resections for colorectal liver metastases
Primary Outcome Measure Information:
Title
Differences in inflammatory response
Description
Differences in POD 1 levels of IL6 and IL8
Time Frame
Preoperative and postoperative day 1
Secondary Outcome Measure Information:
Title
Differences in tumor stimulating factors
Description
Differences in levels of VEGF, HIF-1α, MMP-9 and COX2 in both humoral and normal liver tissue
Time Frame
One week after surgery
Title
Overall Survival
Description
From surgery to date of death or last follow up. Data will be reported in months
Time Frame
1-3-5 years
Title
Recurrence free survival
Description
From surgery to recurrence either in the liver or elsewhere. Data will be reported in months
Time Frame
1-3-5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26496309
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. Erratum In: Medicine (Baltimore). 2016 Mar;95(10):e367e.
Results Reference
background
PubMed Identifier
18333082
Citation
Ueda K, Turner P, Gagner M. Stress response to laparoscopic liver resection. HPB (Oxford). 2004;6(4):247-52. doi: 10.1080/13651820410023987.
Results Reference
background
PubMed Identifier
15136930
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.
Results Reference
background
Learn more about this trial
The Inflammatory Response to Stress and Angiogenesis in Liver Resection
We'll reach out to this number within 24 hrs