Scandinavian Cohort Study for Optimal Use of Portal Vein Embolization

NCT ID: NCT04182386

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-01

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatic Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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rPVE

Right portal vein embolization. All patients subjected to selective right portal vein embolization prior to planned hepatobiliary surgery.

Portal vein embolization

Intervention Type PROCEDURE

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.

Portal vein embolization

Intervention Type PROCEDURE

Selective preoperative portal vein embolization

Interventions

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Portal vein embolization

Selective preoperative portal vein embolization

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Right-sided PVE

Exclusion Criteria

* Left-sided PVE
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ernesto Sparrelid

Acting Head of HPB Surgery, MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ernesto Sparrelid, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Locations

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Karolinska University Hospital

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Ernesto Sparrelid, MD PhD

Role: CONTACT

+46-708-880787

Stefan Gilg, MD PhD

Role: CONTACT

+46-702-677722

Facility Contacts

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Ernesto Sparrelid, MD PhD

Role: primary

Other Identifiers

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Scandinavian PVE study

Identifier Type: -

Identifier Source: org_study_id

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