Scandinavian Cohort Study for Optimal Use of Portal Vein Embolization
1 other identifier
observational
300
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 22, 2019
CompletedFirst Posted
Study publicly available on registry
December 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedMarch 31, 2022
March 1, 2022
9.4 years
November 22, 2019
March 29, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Future liver remnant hypertrophy
Increase in future liver remnant, (%)
Based on radiology around 4 weeks before and after intervention
Secondary Outcomes (3)
Effect of segment 4 embolization on hypertrophy
Based on radiology around 4 weeks before and after intervention
Effect of hyperbilirubinemia on hypertrophy
Based on radiology around 4 weeks before and after intervention
Effect of sarcopenia on hypertrophy
Based on radiology around 4 weeks before and after intervention
Study Arms (2)
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.
Interventions
Eligibility Criteria
Scandinavian patients subjected to PVE at 6 hepatobiliary centers during the study period.
You may qualify if:
- Right-sided PVE
You may not qualify if:
- Left-sided PVE
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Karolinska University Hospital
Stockholm, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ernesto Sparrelid, MD PhD
Karolinska University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Acting Head of HPB Surgery, MD PhD
Study Record Dates
First Submitted
November 22, 2019
First Posted
December 2, 2019
Study Start
August 1, 2012
Primary Completion
December 31, 2021
Study Completion
December 31, 2022
Last Updated
March 31, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- Data will be made available to other researchers on demand.
- Access Criteria
- Data will be made available to other researchers on demand.
Data will be made available to other researchers on demand.