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Prevention of Liver Damage During Liver Surgery (LTR)

Primary Purpose

Liver Tumors

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
placebo
adenosine
adenosine
Liver resection
Sponsored by
Ludwig-Maximilians - University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Liver Tumors focused on measuring liver surgery

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)

Inclusion Criteria:

  • elective resection of liver tumors
  • age 18 to 80 years
  • informed consent

Exclusion Criteria:

  • chronic obstructive pulmonary disease
  • heart insufficiency NYHA III-IV
  • atrio-ventricular conductance blockage II. (Mobitz) or III. degree
  • atrial fibrillation
  • coronary heart disease (CCS III. or IV. degree)
  • arterial hypertension
  • acute renal failure
  • increased intracranial pressure
  • gout
  • pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Active Comparator

    Active Comparator

    Arm Label

    1

    2

    3

    Arm Description

    liver resection with Pringle + placebo

    liver resection with Pringle + adenosine preconditiong

    liver resection with Pringle + adenosine pre- and postconditioning

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 17, 2009
    Last Updated
    February 17, 2009
    Sponsor
    Ludwig-Maximilians - University of Munich
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00845689
    Brief Title
    Prevention of Liver Damage During Liver Surgery
    Acronym
    LTR
    Official Title
    Study on the Potential Role of Intraoperative Hepatoprotection During Liver Resections
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2009
    Overall Recruitment Status
    Unknown status
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Ludwig-Maximilians - University of Munich

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Liver damage as a consequnce of ischemia (I) and reperfusion (R) is known to harm the liver and could hence be a critical factor of the postoperative outcome of patients undergoing liver surgery. In order to protect the liver from ischemic damage following interventions such as the Pringle Maneuver, preconditioning has been successfully applied in various animal models as well as in humans. Since ischemia inevitably leads to cell hypoxia and subsequnet release of endogenuous metabolites, the investigators hypothesize that instead of brief periods of ischemia, the exogenuous infusion of purine analogues may also protect against subsequent prolonged periods of ischemia. Moreover, after reperfusion, the antiinflamamtory action of purine ananlogue infusion can further attenuated liver damage.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Liver Tumors
    Keywords
    liver surgery

    7. Study Design

    Study Phase
    Phase 1, Phase 2

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Placebo Comparator
    Arm Description
    liver resection with Pringle + placebo
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    liver resection with Pringle + adenosine preconditiong
    Arm Title
    3
    Arm Type
    Active Comparator
    Arm Description
    liver resection with Pringle + adenosine pre- and postconditioning
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    NaCl 0,9 %
    Intervention Type
    Drug
    Intervention Name(s)
    adenosine
    Intervention Description
    intravenous infusion of adenosine 0, 2 %
    Intervention Type
    Drug
    Intervention Name(s)
    adenosine
    Intervention Description
    intravenous infusion of adenosine 0,2 %
    Intervention Type
    Procedure
    Intervention Name(s)
    Liver resection
    Intervention Description
    Liver resection with Pringle maneuver

    10. Eligibility

    Eligibility Criteria
    Inclusion Criteria: elective resection of liver tumors age 18 to 80 years informed consent Exclusion Criteria: chronic obstructive pulmonary disease heart insufficiency NYHA III-IV atrio-ventricular conductance blockage II. (Mobitz) or III. degree atrial fibrillation coronary heart disease (CCS III. or IV. degree) arterial hypertension acute renal failure increased intracranial pressure gout pregnancy

    12. IPD Sharing Statement

    Learn more about this trial

    Prevention of Liver Damage During Liver Surgery

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