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

University of Zurich (UZH)

Status and phase: Completed; Phase 4

Conditions: Liver Regeneration

Treatments: Drug: pentoxyfilline; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00957619

StV 7-2006

Details and patient eligibility

About

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.

Full description

Liver resection is for many patients with primary or secondary hepatic malignancies the only curative treatment option. Often, the complete clearance of the hepatic tumor disease can be only achieved by extended liver resections. Clinical studies have demonstrated that intra-operative blood loss is associated reduced outcome after major liver resection. An effective strategy to reduce blood loss is the occlusion of the portal triad (Pringle manoeuvre). On the other hand, inflow occlusion results in ischemia- and reperfusion (I/R) injury. Randomized trials have shown that ischemic preconditioning (10 min clamping, 10 min reperfusion) and intermittent clamping (15 min clamping, 5 min reperfusion) result in reduction of the I/R injury. Another potential strategy to reduce I/R injury is the pharmacological protection. One promising drug is pentoxyfilline (PTF) which has vasodilative and hemorheologic effects. Furthermore, PTF suppresses the TNF release. These effects may be also protective in major liver resection under inflow occlusion (Pringle manoeuvre)and increase the liver regeneration. Therefore, we designed a randomised prospective trial to investigate the effects of PTF treatment in liver resection under inflow occlusion. The specific aims of the research project are:The investigators hypothecate that pentoxyfilline increases significantly the liver regeneration and reduces significantly ischemia and reperfusion (I/R) injury in liver using aspartate aminotransferase (AST) and alanine aminotransferase (ALT) as marker of I/R injury.

Enrollment: 100 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

pentoxyfilline group

Active Comparator group

Description:

pentoxyfilline group

Treatment:

Drug: pentoxyfilline

placebo group

Placebo Comparator group

Description:

placebo group

Treatment:

Drug: Placebo