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
About this trial
This is an interventional trial for Liver Tumors focused on measuring liver surgery
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
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
NCT ID
NCT00845689
First Posted
February 17, 2009
Last Updated
February 17, 2009
Sponsor
Ludwig-Maximilians - University of Munich
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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