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

NCT ID: NCT03426358

Last Updated: 2022-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-28
• Study Completion Date: 2021-12-31

Brief Summary

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.

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.

Conditions

Veno Occlusive Disease, Hepatic; Sinusoidal Obstruction Syndrome; Stem Cell Transplant Complications

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients undergoing HSCT

LSM assessed by Elastographic Techniques

Group Type: EXPERIMENTAL

LSM assessed by Elastographic Techniques

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Davide Festi

Principal Investigator (PI)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio Colecchia, M.D.

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera-Universitaria Integrata di Verona

Francesca Bonifazi, Ph.D. M.D.

Role: STUDY_CHAIR

Azienda Ospedaliera-Universitaria Sant'Orsola Malpighi di Bologna

Andrea Passion, Prof. M.D.

Role: STUDY_CHAIR

Azienda Ospedaliera-Universitaria Sant'Orsola Malpighi di Bologna

Locations

Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi.

Bologna, BO, Italy

Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, Italy

Azienda Ospedaliera "Card. G. Panico"

Tricase, Lecce, Italy

Istituto Clinico Humanitas

Rozzano, Milano, Italy

Policlinico Umberto I - Università la Sapienza

Roma, RM, Italy

Azienda Ospedaliera-Nazionale SS. Antonio e Biagio e Cesare Arrigo

Alessandria, , Italy

Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona

Ancona, , Italy

Azienda Ospedaliero-Universitaria Consorziale - Policlinico di Bari

Bari, , Italy

ASST Papa Giovanni XXIII Ospedali riuniti di Bergamo

Bergamo, , Italy

Azienda Sanitaria dell'Alto Adige

Bolzano, , Italy

Spedali Civili di Brescia, UO Ematologia

Brescia, , Italy

Policlinico Vittorio Emanuele - Presidio Ferrarotto

Catania, , Italy

Azienda Ospedaliera-Universitaria Careggi

Florence, , Italy

Azienda Ospedaliera-Universitaria Meyer

Florence, , Italy

Ospedale Policlinico San Martino

Genova, , Italy

Ospedale Vito Fazzi

Lecce, , Italy

Ospedale dell'Angelo

Mestre, , Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, , Italy

Ospedale Maggiore Policlinico di Milano

Milan, , Italy

Ospedale San Raffaele

Milan, , Italy

Azienda Ospedaliera-Universitaria di Modena

Modena, , Italy

Ospedale Pediatrico Pausilipon

Napoli, , Italy

Policlinico Federico II

Napoli, , Italy

Azienda Ospedaliero-Universitaria di Padova

Padua, , Italy

Azienda Ospedaliera Ospedali riuniti Villa Sofia- Cervello

Palermo, , Italy

Azienda Ospedaliero-Universitaria Ospedale Maggiore di Parma

Parma, , Italy

Azienda Sanitaria Locale di Pescara

Pescara, , Italy

Azienda Ospedaliero-universitaria Pisana, UO Ematologia

Pisa, , Italy

Azienda Ospedaliero-Universitaria Pisana, UO Oncoematologia Pediatrica

Pisa, , Italy

Arcispedale S. Maria Nuova di Reggio Emilia

Reggio Emilia, , Italy

Ospedale Pediatrico Bambino Gesù

Roma, , Italy

Policlinico Tor Vergata

Roma, , Italy

Policlinico Universitario A. Gemelli

Roma, , Italy

Azienda Ospedaliero-Universitaria Città della Salute e della Scienza

Torino, , Italy

Azienda Ospedaliero-Universitaria Integrata di Udine

Udine, , Italy

Azienda Ospedaliero-Universitaria Integrata di Verona

Verona, , Italy

Azienda Ospedaliera di Vicenza

Vicenza, , Italy

Countries

Italy

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Ravaioli F, Colecchia A, Peccatori J, Pagliara D, Grassi A, Barbato F, Masetti R, Sarina B, Sica S, Cesaro S, Nozzoli C, Assanto GM, Prezioso L, Santarone S, Saglio F, Vanni E, Olivieri A, Delia M, Benedetti E, Zallio F, Pane F, Skert C, Menconi M, Benedetti F, De Felice F, Colecchia L, Belotti T, Alemanni LV, Ursi M, Marasco G, Roberto M, Vestito A, Dajti E, Garcovich M, Bramanti S, Taurino D, Quagliarella F, Ciceri F, Prete A, Pession A, Festi D; ELASTOVOD Study Group; Bonifazi F. Diagnostic accuracy of liver stiffness measurement for the diagnosis of veno-occlusive disease/sinusoidal obstruction syndrome after hematopoietic stem cell transplantation (HSCT), the ELASTOVOD STUDY: an investigator-initiated, prospective, multicentre diagnostic clinical trial. Bone Marrow Transplant. 2025 Jul;60(7):978-993. doi: 10.1038/s41409-025-02570-w. Epub 2025 Apr 19.

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Other Identifiers

ELASTOVOD

Identifier Type: -

Identifier Source: org_study_id