Study of the Protective Effect of Mechanism of Pentoxyfilline After Major Liver Resection Under Inflow Occlusion (Pringle Manoeuvre)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00957619
• Date of registration: 11/08/2009
• Prospective Registration: No
• Primary sponsor: University of Zurich
• Public title: Study of the Protective Effect of Mechanism of Pentoxyfilline After Major Liver Resection Under Inflow Occlusion (Pringle Manoeuvre)
• Scientific title: Study of the Protective Effect of Mechanism of Pentoxyfilline After Major Liver Resection Under Inflow Occlusion (Pringle Manoeuvre)
• Date of first enrolment: March 2006
• Target sample size: 100
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00957619
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Switzerland

Contacts

• Name: Pierre Alain Clavien, MD, PhD
• Affiliation: Departmente of Visceral and Transplantation Surgery

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age > 18 years

- Major liver resection (hemihepatectomies and extended hemihepatectomies) for benign
and malignant lesions

- Macroscopic and microscopic normal liver parenchyma

- No underlying liver disease

- Normal preoperative liver tests (quick, bilirubin, AST, ALT)

- Signed informed consent

Exclusion Criteria:

- Age < 18 years

- Minor liver resections (less than hemihepatectomies) or wedge resections

- Macroscopic and microscopic appearance of liver fibrosis or cirrhosis

- Underlying liver disease such as viral hepatitis, cirrhosis, etc.

- Pathological preoperative liver tests (quick, bilirubin, AST, ALT)

- Intolerance to xanthine derivatives

- History of myocardial or cerebrovascular insult

- Total vascular exclusion during liver resection

- Intra-operative detection of unresectable tumor disease

- No signed informed consent



Age minimum: 18 Years
Age maximum: 90 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Liver Regeneration

Intervention(s)

Drug: pentoxyfilline

Drug: Placebo

Primary Outcome(s)

I. To determine the regeneration of the liver after liver resection with and without PTF treatment [Time Frame: pre- and up to day 8 after liver resection]

Secondary Outcome(s)

Il-6, TNF, procalcitonin for regeneration.AST & ALT peak for ischemic reperfusion injury. If PTF treatment has protective effects in steatotic/fibrotic liver. [Time Frame: pre- and up to 8 days postoperatively]

Secondary ID(s)

StV 7-2006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors