Scandinavian Cohort Study for Optimal Use of Portal Vein Embolization

Overview

Several aspects on the use of portal vein embolization (PVE) are poorly studied and todays recommendations are based on low-grade evidence. In this Scandinavian multicenter cohort study we will study some of the controversial aspects on the use of PVE to try to provide clearer answers on its optimal use. Six tertiary university hospital hepatobiliary units in Sweden, Norway and Denmark participate and contribute with all PVE procedures performed at their units during the study period. We will then study several aspects PVE technique in relation to induced hypertrophy and surgical outcome.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: December 31, 2019

Interventions

  • Procedure: Portal vein embolization
    • Selective preoperative portal vein embolization

Arms, Groups and Cohorts

  • rPVE
    • Right portal vein embolization. All patients subjected to selective right portal vein embolization prior to planned hepatobiliary surgery.
  • rPVE+S4
    • Right portal vein embolization including segment 4 portal vein branches. All patients subjected to selective right portal vein embolization including segment 4 portal vein branches prior to planned hepatobiliary surgery.

Clinical Trial Outcome Measures

Primary Measures

  • Future liver remnant hypertrophy
    • Time Frame: Based on radiology around 4 weeks before and after intervention
    • Increase in future liver remnant, (%)

Secondary Measures

  • Effect of segment 4 embolization on hypertrophy
    • Time Frame: Based on radiology around 4 weeks before and after intervention
    • Increase in future liver remnant (%) dependeing on if segment 4 is embolized or not.
  • Effect of hyperbilirubinemia on hypertrophy
    • Time Frame: Based on radiology around 4 weeks before and after intervention
    • Increase in future liver remnant (%) dependeing on the levels of bilirubin before portal vein embolization.
  • Effect of sarcopenia on hypertrophy
    • Time Frame: Based on radiology around 4 weeks before and after intervention
    • Increase in future liver remnant (%) dependeing on the level of sarcopenia before portal vein embolization.

Participating in This Clinical Trial

Inclusion Criteria

  • Right-sided PVE

Exclusion Criteria

  • Left-sided PVE

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Karolinska University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ernesto Sparrelid, Acting Head of HPB Surgery, MD PhD – Karolinska University Hospital
  • Overall Official(s)
    • Ernesto Sparrelid, MD PhD, Principal Investigator, Karolinska University Hospital
  • Overall Contact(s)
    • Ernesto Sparrelid, MD PhD, +46-708-880787, ernesto.sparrelid@ki.se

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