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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
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -

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

    First Posted
    April 20, 2017
    Last Updated
    April 27, 2017
    Sponsor
    University Hospital, Ghent
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    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

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    The Inflammatory Response to Stress and Angiogenesis in Liver Resection

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