Detection of Sinusoidal Obstruction Syndrome With Ultrasound After Allogeneic HSCT

Sinusoidal Obstruction Syndrome Clinical Trial

Official title:

A Retrospective Study About Detection of Sinusoidal Obstruction Syndrome With Ultrasound After Allogeneic Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04141735
• Other study ID #: SOS detection CHU Nancy
• Status: Completed
• Start date: September 2016
• Est. completion date: September 2018

Study information

• Verified date: November 2019
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

We would like conduct a retrospective study in our center to evaluate the early detection of sinusoidal obstruction syndrome with hepatic ultrasound after allogeneic hematopoietic stem cell transplantation.

Description:

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 early detection of this complication with systematic ultrasound. In this study, we want to evaluate in a retrospective study the interest of this technique in the early and systematic detection of sinusoidal obstruction syndrome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• all adult patients with allogeneic hematopoietic stem cell transplantation in Nancy University Hospital between Sep 2016 and Sep 2018

Exclusion Criteria:

• age < 18 years old

Related Conditions & MeSH terms

• Hepatic Veno-Occlusive Disease
• Sinusoidal Obstruction Syndrome
• Syndrome

Intervention

Diagnostic Test:
• ultrasound
no intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

References & Publications (2)

Lassau N, Auperin A, Leclere J, Bennaceur A, Valteau-Couanet D, Hartmann O. Prognostic value of doppler-ultrasonography in hepatic veno-occlusive disease. Transplantation. 2002 Jul 15;74(1):60-6. — View Citation

Mohty M, Malard F, Abecassis M, Aerts E, Alaskar AS, Aljurf M, Arat M, Bader P, Baron F, Bazarbachi A, Blaise D, Ciceri F, Corbacioglu S, Dalle JH, Dignan F, Fukuda T, Huynh A, Masszi T, Michallet M, Nagler A, NiChonghaile M, Okamoto S, Pagliuca A, Peters — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence in the cohort of sinusoidal obstruction syndrome	incidence	up to 24 months