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NCT Number: NCT04141735

Detection of Sinusoidal Obstruction Syndrome With Ultrasound After Allogeneic HSCT

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • age < 18 years old

Treatment and study plan

Ultrasound

Diagnostic Test

no intervention

Primary outcomes

  1. incidence in the cohort of sinusoidal obstruction syndrome

    Time frame: up to 24 months

    incidence

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 28, 2019
Registry last updated
Sep 26, 2025

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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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