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临床试验/NCT05660759
NCT05660759已完成不适用

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 个研究点 分布在 1 个国家目标入组 265 人开始时间: 2022年12月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
265
试验地点
1
主要终点
FLR hypertrophy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • 未提供

结局指标

主要结局

FLR hypertrophy

时间窗: Spring 2023

次要结局

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

研究者

发起方
Linkoeping University
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Bergthor Björnsson

Professor

Linkoeping University

研究点 (1)

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