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Comparison of N-butyl-cyanoacrylate and Micro Parti-cles Effect in Inducing Liver Hypertrophy After PVE

NCT ID: NCT05660759

Last Updated: 2022-12-21

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

COMPLETED

Total Enrollment

265 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-13

Study Completion Date

2022-12-13

Brief Summary

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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.

Detailed Description

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With expansion of indications for major liver surgery, portal vein embolization (PVE) is increasingly used in order to induce hypertrophy of the future liver remnant (FLR). De-spite vide variety of materials available to occlude the portal veins the most commonly used are cyanoacrylate and microparticles/spheres. Earlier studies have failed to show superiority of one over the other in terms of hypertrophy of the FLR while PVE with cy-anoacrylate seems to be less time consuming. Two small previous studies from single centers have shown greater growth by cyanoacrylate compared to particles (1) with 90 included patients and the second study with 34 included patients (2), but larger reviews have failed (3). Cyanoacrylate might give a more robust FLR hypertrophy (4) . The main problem in evaluating previous studies has been the large heterogeneity and the often poorly described study populations.

Conditions

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Portal Vein Embolization, Liver, Hypertrophy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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NBCA

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

Portal vein embolization

Intervention Type PROCEDURE

Portal vein emboliazation with either NBCA or micro particles.

Particles

Patients that recieved portal vein embolization with micro particles.

Portal vein embolization

Intervention Type PROCEDURE

Portal vein emboliazation with either NBCA or micro particles.

Interventions

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Portal vein embolization

Portal vein emboliazation with either NBCA or micro particles.

Intervention Type PROCEDURE

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role collaborator

Skane University Hospital

OTHER

Sponsor Role collaborator

Linkoeping University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Bergthor Björnsson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bergthor Björnsson, PhD

Role: PRINCIPAL_INVESTIGATOR

Linkoeping University

Locations

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Linköping University Hospital

Linköping, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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DB_01

Identifier Type: -

Identifier Source: org_study_id