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

NCT00957619 | Completed Phase 4

• 1 other identifier: StV 7-2006
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothecate that pentoxyfilline increase significantly the liver regeneration and reduces significantly ischemia and reperfusion (I/R) injury in major liver using aspartate aminotransferase (AST) and alanine aminotransferase (ALT) as marker of I/R injury.

Conditions

Liver Regeneration

Keywords

pentoxyfilline; liver regeneration; major liver resection; reduction of the I/R injury

Outcome Measures

Primary Outcomes (1)

• I. To determine the regeneration of the liver after liver resection with and without PTF treatment

  pre- and up to day 8 after liver resection

Secondary Outcomes (1)

• Il-6, TNF, procalcitonin for regeneration.AST & ALT peak for ischemic reperfusion injury. If PTF treatment has protective effects in steatotic/fibrotic liver.

  pre- and up to 8 days postoperatively

Study Arms (2)

pentoxyfilline group

ACTIVE COMPARATOR

pentoxyfilline group

Drug: pentoxyfilline

placebo group

PLACEBO COMPARATOR

placebo group

Drug: Placebo

Interventions

pentoxyfilline DRUG

The total dose of 1 mg/kg/h will be used. At the preoperative day half of the daily dose will be given as a 4-hour short-term infusion within 24 hours before surgery. Afterwards, a continuous intravenous infusion of PTX 1 mg/kg of body weight per hour will be started intra-operatively and will be continued for a total of 72 hours after surgery.

pentoxyfilline group

Placebo DRUG

This group will be treated with saline solution at the same time points. The infusion volume and infusion rate of saline solution correspond to that of the PTF group.

placebo group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Intra-operative detection of unresectable tumor disease
• No signed informed consent

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Department of Visceral and Transplantation Surgery

Zurich, Canton of Zurich, 8091, Switzerland

Location

Study Officials

• Pierre Alain Clavien, MD, PhD

  Departmente of Visceral and Transplantation Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: August 11, 2009
• First Posted: August 12, 2009
• Study Start: March 1, 2006
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: February 10, 2015

Record last verified: 2015-02

Locations

CH (1)