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临床试验/NCT04141735
NCT04141735已完成不适用

A Real-life Study About Prediction of Sinusoidal Obstruction Syndrome With Ultrasound and Elastography Before Allogeneic Hematopoietic Stem Cell Transplantation

Central Hospital, Nancy, France0 个研究点目标入组 114 人开始时间: 2016年9月1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
114
主要终点
incidence in the cohort of sinusoidal obstruction syndrome

研究概览

简要总结

We would like conduct a real-life study in our center to evaluate the early detection of sinusoidal obstruction syndrome with hepatic ultrasound or elastography before allogeneic hematopoietic stem cell transplantation.

详细描述

The diagnosis of sinusoidal obstruction syndrome also know as veno-occlusive disease is often difficult. This is a potentially life-threatening complication that can develop after allogeneic hematopoietic stem cell transplantation. Clinically, sinusoidal obstruction syndrome is charaterized by hepatomegaly, right upper quadrant pain, jaundice and ascites. The diagnosis is based on biological parameters (bilirubin increase ≥ 2mg/dL or 34.2µmol/L) and clinical evaluation (sodium fluid retention with weight gain > 5%, ascites, painful hepatomegaly) (reference : M. Mohty and al. Revised criteria for sinusoidal obstruction syndrome, Bone Marrow Transplantation (2016) 906-912).

Early therapeutic intervention is pivotal for survival in sinusoidal obstruction syndrome, thus a rapid and reliable diagnosis has to be made. To rule out major differential diagnosis, a reliable imaging method is needed. In practice, doppler ultrasonography, is helpful to detect hepatomegaly and ascites but also is an help to explore well defined criteria of sinusoidal obstruction syndrome already published. For sonography criteria: hepatomegaly (3 measures) with an increase of 2cm versus baseline, gallbladder wall thickening, ascites or 3 criteria of a native VOD; splenomegaly, increase of the portal vein diameter, decrease of the hepatic vein diameter, visualisation of the para umbilical vein and for the doppler : increase of the hepatic artery RI (>0.75), monophasic flow in the hepatic veins (venous retraction is very typical but very late), flow demodulation on portal vein, decrease in portal flow, portal flow congestion, reversed flow, flow recorded in the para-umbilical vein ; all five last signs are late (reference : Lassau N. et al Prognostic value of doppler ultrasonography in hepatic veno occlusive disease. Transplantation 2002 jul 15 ;74(1) :60-6). These criteria can confirm the diagnosis : 6 signs of wich the first 3 can affirm the diagnosis with certainty in combination with clinical and biological parameters. There is currently a few data in the literature about prediction or early detection of this complication with systematic ultrasound +/- elastography. In this study, we want to evaluate in a real-life study the interest of this technique in the early and systematic prediction/ detection of sinusoidal obstruction syndrome.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all adult patients with allogeneic hematopoietic stem cell transplantation in Nancy University Hospital between Sep 2016 and dec 2024

排除标准

  • age < 18 years old

结局指标

主要结局

incidence in the cohort of sinusoidal obstruction syndrome

时间窗: up to 24 months

incidence

次要结局

未报告次要终点

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

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