The Inflammatory Response to Stress and Angiogenesis in Liver Resection
1 other identifier
interventional
40
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2010
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2011
CompletedFirst Submitted
Initial submission to the registry
April 20, 2017
CompletedFirst Posted
Study publicly available on registry
April 27, 2017
CompletedMay 1, 2017
April 1, 2017
1.2 years
April 20, 2017
April 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Differences in inflammatory response
Differences in POD 1 levels of IL6 and IL8
Preoperative and postoperative day 1
Secondary Outcomes (3)
Differences in tumor stimulating factors
One week after surgery
Overall Survival
1-3-5 years
Recurrence free survival
1-3-5 years
Study Arms (2)
Open Liver Resection
ACTIVE COMPARATORConventional open liver resection trough subcostal incision
Laparoscopic Liver Resection
EXPERIMENTALPure laparoscopic liver resection without hand assistance
Interventions
liver resections for colorectal liver metastases
Eligibility Criteria
You may qualify if:
- years old
- Patients with colorectal liver metastases
- Colorectal liver metastases ≤10 cm in size -
You may not qualify if:
- Patients not fit for laparoscopic surgery due to comorbidities
- Patients with tumors close or infiltrating the major vessels -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
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.
PMID: 26496309BACKGROUNDUeda K, Turner P, Gagner M. Stress response to laparoscopic liver resection. HPB (Oxford). 2004;6(4):247-52. doi: 10.1080/13651820410023987.
PMID: 18333082BACKGROUNDBuunen 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.
PMID: 15136930BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2017
First Posted
April 27, 2017
Study Start
April 1, 2010
Primary Completion
June 30, 2011
Study Completion
June 30, 2011
Last Updated
May 1, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share