Status:

COMPLETED

Hypothermic Perfusion During Hemihepatectomy

Lead Sponsor:

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Conditions:

Hepatic Ischemia-reperfusion Injury

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Rationale Currently, hepatic resection is often the only curative treatment for primary or secondary hepatic malignancies and is also frequently performed in patients with benign liver tumors to prev...

Eligibility Criteria

Inclusion

  • Patients scheduled for right hemihepatectomy under vascular inflow occlusion for a malignant or benign hepatic tumor
  • Diagnostic exclusion of hepatic co-morbidity, that is:
  • Cirrhosis,
  • Severe steatosis (≥ 30%),
  • Cholestasis, and
  • Hepatitis B/C infection
  • Age ≥ 18 years
  • Signed informed consent obtained prior to any study-specific procedure
  • ASA classification I-III

Exclusion

  • Patients diagnosed with any of the hepatic co-morbidities listed under point 2 of the inclusion criteria
  • Age \< 18 years
  • BMI \> 35 kg/m2
  • ASA classification IV/V
  • Patient is scheduled for a combined surgical procedure (e.g., bile duct resection, gastrointestinal procedures)
  • Patient underwent liver resection ≤ 1 year prior to scheduled surgery
  • Emergency operations
  • Pregnancy or breast feeding

Key Trial Info

Start Date :

February 1 2012

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2015

Estimated Enrollment :

22 Patients enrolled

Trial Details

Trial ID

NCT01499979

Start Date

February 1 2012

End Date

August 1 2015

Last Update

January 26 2016

Active Locations (1)

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1

Academic Medical Center (AMC)

Amsterdam, North Holland, Netherlands, 1105 AZ