Liver Stiffness Measurement Predicts VOD/SOS Development (ELASTOVOD ITALIAN MULTICENTRIC STUDY) (ELASTOVOD)

April 13, 2022 updated by: Davide Festi, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Usefulness of Liver Stiffness Measurement in Predicting Hepatic Veno-Occlusive Disease Development in Patients Who Undergo HSCT: a Multicentric Prospective Study

ELASTOVOD is a prospective multicenter study, involving several centers of Onco-haematology in Italy. Investigators perform hepatic elastographic measurements (with Transient Elastography, ARFI or 2D-SWE) on patients undergoing HSCT, at baseline before transplantation (T0) and at T1/T2/T3 after HSCT (+9/10, +15/17, +22/24).

SOS/VOD diagnosis was performed according to clinical criteria.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sinusoidal Obstruction Syndrome (SOS), also known as hepatic Veno-Occlusive Disease (VOD), is a life-threatening complication in patients undergoing Hematopoietic Stem Cells Transplantation (HSCT) for onco-haematological disease.

In the severe form, mortality rate can be high as 80%. Patients developing SOS/VOD present a higher survival rate when earlier SOS/VOD- specific therapy has initiated. In order to get better outcomes, it is necessary to improve early diagnosis of SOS/VOD, finding new non--invasive diagnostic instruments.

The aim of this prospective multicenter study is to assess in a large, mixed (adult and paediatric) population undergoing HSCT, the diagnostic role for SOS/VOS of Liver Stiffness Measurement (LSM), assessed by different elastographic methods.

In our study, Liver Stiffness Measurement (LSM) can be measured by Transient Elastography (TE) with Fibroscan, Acoustic Radiation Force Impulse (ARFI) or 2D-Share Wave Elastography (2D-SWE). Once chosen an elastometric method at baseline, the same must be used for all subsequent evaluations of the patient.

In patients undergoing HSCT, within one month, a complete baseline evaluation is provided. Baseline evaluation (T0) includes: signature of informed consent, haematological and hepatological anamnesis, in order to assess comorbidities and risk factors for hepato-biliary complications; complete laboratory tests; abdominal Color-Doppler Ultrasound and hepatic Elastography (with Transient Elastography, ARFI or 2D-SWE).

After conditioning and HSCT, each patient is evaluated at T1 (+9/10), T2 (+15/17), T3 (+22/24) with: bedside Elastography, laboratory tests, clinical examination based on clinical criteria for SOS/VOD diagnosis (e.g. Baltimora criteria, modified Seattle criteria, new EBMT criteria).

RUCAM-CIOMS Scale can be assess, in order to establish DILI (Drug Induced Liver Injury) diagnosis, as well.

In case of SOS/VOD suspicion, patient goes through an intense monitoring period: laboratory tests, clinical evaluation for SOS/VOD diagnosis, Color-Doppler US and Elastography are repeatedly performed in next days. This monitoring period stops if diagnosis of SOS/VOD or other diagnosis is reached.

Each center will prospectively collect data according to an electronic e-CFR on REDCap (Research Electronic Data Capture) system, a web application designed to support data capture for research studies in a secure manner.

Study Type

Interventional

Enrollment (Actual)

1101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alessandria, Italy
        • Azienda Ospedaliera-Nazionale SS. Antonio e Biagio e Cesare Arrigo
      • Ancona, Italy
        • Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona
      • Bari, Italy
        • Azienda Ospedaliero-Universitaria Consorziale - Policlinico di Bari
      • Bergamo, Italy
        • ASST Papa Giovanni XXIII Ospedali riuniti di Bergamo
      • Bolzano, Italy
        • Azienda Sanitaria dell'Alto Adige
      • Brescia, Italy
        • Spedali Civili di Brescia, UO Ematologia
      • Catania, Italy
        • Policlinico Vittorio Emanuele - Presidio Ferrarotto
      • Firenze, Italy
        • Azienda Ospedaliera-Universitaria Careggi
      • Firenze, Italy
        • Azienda Ospedaliera-Universitaria Meyer
      • Genova, Italy
        • Ospedale Policlinico San Martino
      • Lecce, Italy
        • Ospedale Vito Fazzi
      • Mestre, Italy
        • Ospedale dell'Angelo
      • Milano, Italy
        • Ospedale San Raffaele
      • Milano, Italy
        • ASST Grande Ospedale Metropolitano Niguarda
      • Milano, Italy
        • Ospedale Maggiore Policlinico di Milano
      • Modena, Italy
        • Azienda Ospedaliera-Universitaria di Modena
      • Napoli, Italy
        • Policlinico Federico II
      • Napoli, Italy
        • Ospedale Pediatrico Pausilipon
      • Padova, Italy
        • Azienda Ospedaliero-Universitaria di Padova
      • Palermo, Italy
        • Azienda Ospedaliera Ospedali riuniti Villa Sofia- Cervello
      • Parma, Italy
        • Azienda Ospedaliero-Universitaria Ospedale Maggiore di Parma
      • Pescara, Italy
        • Azienda Sanitaria Locale di Pescara
      • Pisa, Italy
        • Azienda Ospedaliero-universitaria Pisana, UO Ematologia
      • Pisa, Italy
        • Azienda Ospedaliero-Universitaria Pisana, UO Oncoematologia Pediatrica
      • Reggio Emilia, Italy
        • Arcispedale S. Maria Nuova di Reggio Emilia
      • Roma, Italy
        • Ospedale Pediatrico Bambino Gesù
      • Roma, Italy
        • Policlinico Universitario A. Gemelli
      • Roma, Italy
        • Policlinico Tor Vergata
      • Torino, Italy
        • Azienda Ospedaliero-Universitaria Città della Salute e della Scienza
      • Udine, Italy
        • Azienda Ospedaliero-Universitaria Integrata di Udine
      • Verona, Italy
        • Azienda Ospedaliero-Universitaria Integrata di Verona
      • Vicenza, Italy
        • Azienda Ospedaliera di Vicenza
    • BO
      • Bologna, BO, Italy
        • Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi.
    • Foggia
      • San Giovanni Rotondo, Foggia, Italy
        • Casa Sollievo della Sofferenza
    • Lecce
      • Tricase, Lecce, Italy
        • Azienda Ospedaliera "Card. G. Panico"
    • Milano
      • Rozzano, Milano, Italy
        • Istituto Clinico Humanitas
    • RM
      • Roma, RM, Italy
        • Policlinico Umberto I - Università La Sapienza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 68 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • male or female patients
  • age between 3 and 70
  • patients suffering from an onco-hematological disease that have an indication for either allogenic or autologous hematopoietic stem cells transplantation
  • obtaining of informed consent

Exclusion Criteria:

  • pathological obesity (BMI >40)
  • pacemaker of implantable defibrillator
  • presence of ascites at baseline

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients undergoing HSCT
LSM assessed by Elastographic Techniques
Device: LSM assessed by Elastographic Techniques
Performing Transient Elastography, ARFI or 2D-SWE on patients at baseline (within 1 month before HSCT) and after HSCT on days +9/10, +15/17, +22/24

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Role of Liver Stiffness Measurement in SOS/VOD development
Time Frame: From HSCT to 30 days after HSCT
To assess in a large, mixed (adult and paediatric) population undergoing HSCT, the role of Liver Stiffness Measurement (LSM), assessed by different elastographic methods, in SOS/VOD diagnosis.
From HSCT to 30 days after HSCT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Antonio Colecchia, M.D., Azienda Ospedaliera-Universitaria Integrata di Verona
  • Study Chair: Francesca Bonifazi, Ph.D. M.D., Azienda Ospedaliera-Universitaria Sant'Orsola Malpighi di Bologna
  • Study Chair: Andrea Passion, Prof. M.D., Azienda Ospedaliera-Universitaria Sant'Orsola Malpighi di Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2015

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

February 2, 2018

First Submitted That Met QC Criteria

February 2, 2018

First Posted (Actual)

February 8, 2018

Study Record Updates

Last Update Posted (Actual)

April 14, 2022

Last Update Submitted That Met QC Criteria

April 13, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELASTOVOD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stem Cell Transplant Complications

Clinical Trials on LSM assessed by Elastographic Techniques

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe