Prevention of Liver Damage During Liver Surgery

Phase 1

• Conditions: Liver Tumors
• Interventions: Drug: placebo; Drug: adenosine; Procedure: Liver resection

• Registration Number: NCT00845689
• Lead Sponsor: Ludwig-Maximilians - University of Munich

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-02
• Study First Submitted: 2009-02-17
• Study First Submitted QC: 2009-02-17
• Last Update Submitted: 2009-02-17
• Study First Posted: 2009-02-18
• Last Update Posted: 2009-02-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Not specified
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	placebo	liver resection with Pringle + placebo
1	Liver resection	liver resection with Pringle + placebo
2	Liver resection	liver resection with Pringle + adenosine preconditiong
3	Liver resection	liver resection with Pringle + adenosine pre- and postconditioning
2	adenosine	liver resection with Pringle + adenosine preconditiong
3	adenosine	liver resection with Pringle + adenosine pre- and postconditioning