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

December 13, 2022 updated by: Bergthor Björnsson, Linkoeping University

N-butyl-cyanoacrylate Glue Versus Micro Particles and the Effect on Inducing Liver Hypertrophy After Portal Vein Embolization- a Retrospective Swedish Multicenter Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

265

Contacts and Locations

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

Study Locations

  • Sweden
      • Linköping, Sweden, 58185
        • Linköping University Hospital

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria: Over 18 years old. Planned for portal vein embolization. -

Exclusion Criteria:

-

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NBCA
Patients that recieved portal vein embolization with n-butyl-cyanoacrylate glue.
Procedure: Portal vein embolization
Portal vein emboliazation with either NBCA or micro particles.
Particles
Patients that recieved portal vein embolization with micro particles.
Procedure: Portal vein embolization
Portal vein emboliazation with either NBCA or micro particles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
FLR hypertrophy
Time Frame: Spring 2023
Spring 2023

Secondary Outcome Measures

Outcome Measure
Time Frame
Degree of hypertrophy
Time Frame: Spring 2023
Spring 2023
Kinetic growth rate
Time Frame: Spring 2023
Spring 2023

Collaborators and Investigators

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

Sponsor

Linkoeping University

Collaborators

Karolinska Institutet
Skane University Hospital

Investigators

  • Principal Investigator: Bergthor Björnsson, PhD, Linkoeping University

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)

December 13, 2022

Primary Completion (Actual)

December 13, 2022

Study Completion (Actual)

December 13, 2022

Study Registration Dates

First Submitted

December 13, 2022

First Submitted That Met QC Criteria

December 13, 2022

First Posted (Actual)

December 21, 2022

Study Record Updates

Last Update Posted (Actual)

December 21, 2022

Last Update Submitted That Met QC Criteria

December 13, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DB_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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