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Clinical Trials/NCT05660759
NCT05660759CompletedNot Applicable

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

Linkoeping University1 site in 1 country265 target enrollmentStarted: December 13, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
265
Locations
1
Primary Endpoint
FLR hypertrophy

Study Overview

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.

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Over 18 years old. Planned for portal vein embolization. -

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

FLR hypertrophy

Time Frame: Spring 2023

Secondary Outcomes

  • Degree of hypertrophy(Spring 2023)
  • Kinetic growth rate(Spring 2023)

Investigators

Sponsor
Linkoeping University
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Bergthor Björnsson

Professor

Linkoeping University

Study Sites (1)

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