Scandinavian Cohort Study for Optimal Use of Portal Vein Embolization

March 29, 2022 updated by: Ernesto Sparrelid, Karolinska University Hospital
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Scandinavian patients subjected to PVE at 6 hepatobiliary centers during the study period.

Description

Inclusion Criteria:

  • Right-sided PVE

Exclusion Criteria:

  • Left-sided PVE

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
rPVE
Right portal vein embolization. All patients subjected to selective right portal vein embolization prior to planned hepatobiliary surgery.
Procedure: Portal vein embolization
Selective preoperative portal vein embolization
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.
Procedure: Portal vein embolization
Selective preoperative portal vein embolization

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Based on radiology around 4 weeks before and after intervention
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.
Based on radiology around 4 weeks before and after intervention
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.
Based on radiology around 4 weeks before and after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Investigators

  • Principal Investigator: Ernesto Sparrelid, MD PhD, Karolinska University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2012

Primary Completion (ACTUAL)

December 31, 2021

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

November 22, 2019

First Submitted That Met QC Criteria

November 27, 2019

First Posted (ACTUAL)

December 2, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Scandinavian PVE study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be made available to other researchers on demand.

IPD Sharing Time Frame

Data will be made available to other researchers on demand.

IPD Sharing Access Criteria

Data will be made available to other researchers on demand.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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