Prevention of Liver Damage During Liver Surgery

Liver Tumors Clinical Trial

— LTR  

Official title:

Study on the Potential Role of Intraoperative Hepatoprotection During Liver Resections

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00845689
• Other study ID #: LMU-202-LTR
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: February 17, 2009
• Last updated: February 17, 2009

Study information

• Verified date: February 2009
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Institutional Review BoardGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Gender: Both
• Age group: N/A and older

Eligibility

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

N/A

Related Conditions & MeSH terms

• Liver Tumors

Intervention

Drug:
• placebo
NaCl 0,9 %
• adenosine
intravenous infusion of adenosine 0, 2 %
• adenosine
intravenous infusion of adenosine 0,2 %

Procedure:
• Liver resection
Liver resection with Pringle maneuver

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich