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Completed

NCT Number: NCT05660759

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

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.

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Key information

Conditions

Portal Vein Embolization, Liver, Hypertrophy Hypertrophy Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Linköping University Hospital

Linköping, 58185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Portal vein embolization

Procedure

Portal vein emboliazation with either NBCA or micro particles.

Primary outcomes

  1. FLR hypertrophy

    Time frame: Spring 2023

Secondary outcomes

  1. Degree of hypertrophy

    Time frame: Spring 2023

  2. Kinetic growth rate

    Time frame: Spring 2023

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Collaborators

  • Karolinska Institutet
  • Skane University Hospital

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 21, 2022
Registry last updated
Dec 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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