Prevention of Liver Damage During Liver Surgery

NCT00845689 | Unknown Phase 1

• 1 other identifier: LMU-202-LTR
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Liver Tumors

Keywords

liver surgery

Study Arms (3)

1

PLACEBO COMPARATOR

liver resection with Pringle + placebo

Drug: placebo; Procedure: Liver resection

2

ACTIVE COMPARATOR

liver resection with Pringle + adenosine preconditiong

Drug: adenosine; Procedure: Liver resection

3

ACTIVE COMPARATOR

liver resection with Pringle + adenosine pre- and postconditioning

Drug: adenosine; Procedure: Liver resection

Interventions

placebo DRUG

NaCl 0,9 %

1

adenosine DRUG

intravenous infusion of adenosine 0, 2 %

2

Liver resection PROCEDURE

Liver resection with Pringle maneuver

1; 2; 3

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Adenosine; Hepatectomy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 1
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 17, 2009
• First Posted: February 18, 2009
• Last Updated: February 18, 2009

Record last verified: 2009-02