NCT05660759

Brief Summary

The aim of this study is to compare hypertrophy of the FLR after PVE with microparticles to hypertrophy after PVE with cyanoacrylate in a material large enough to answer the study question. In addition, other factors that may influence the degree of hypertrophy will be evaluated in a multivariable analysis. The hypothesis is: PVE with cyanoacrylate is superior to PVE with microparticles in terms of FLR hy-pertrophy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

December 13, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
Last Updated

December 21, 2022

Status Verified

December 1, 2022

Enrollment Period

Same day

First QC Date

December 13, 2022

Last Update Submit

December 13, 2022

Conditions

Portal Vein Embolization, Liver, Hypertrophy

Outcome Measures

Primary Outcomes (1)

  • FLR hypertrophy

    Spring 2023

Secondary Outcomes (2)

  • Degree of hypertrophy

    Spring 2023

  • Kinetic growth rate

    Spring 2023

Study Arms (2)

NBCA

Patients that recieved portal vein embolization with n-butyl-cyanoacrylate glue.

Procedure: Portal vein embolization

Particles

Patients that recieved portal vein embolization with micro particles.

Procedure: Portal vein embolization

Interventions

Portal vein embolizationPROCEDURE

Portal vein emboliazation with either NBCA or micro particles.

NBCAParticles

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing portal vein embolization during the study period 2013 - 2021 in Linköping University Hospital, Karolinska Comprehensive Cancer Center and Skåne University Hospital Lund.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linköping University Hospital

Linköping, 58185, Sweden

Location

MeSH Terms

Conditions

Hypertrophy

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Bergthor Björnsson, PhD

    Linkoeping University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 13, 2022

First Posted

December 21, 2022

Study Start

December 13, 2022

Primary Completion

December 13, 2022

Study Completion

December 13, 2022

Last Updated

December 21, 2022

Record last verified: 2022-12

Locations

SE(1)