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

NCT03426358 | Completed DMC

• 1 other identifier: ELASTOVOD
• Study Type: interventional
• Target: 1,101
• Locations: 1 country
• Sites: 37

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.

Conditions

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

Keywords

Veno Occlusive Disease; Sinusoidal Obstruction Syndrome; HSCT; Hematopoietic Stem Cell Transplantation; Stem Cell Transplant Complications; Liver Stiffness Measurement; Sinusoidal Obstructive Syndrome; Transient Elastography

Outcome Measures

Primary Outcomes (1)

• Diagnostic Role of Liver Stiffness Measurement in SOS/VOD development

  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

Study Arms (1)

Patients undergoing HSCT

EXPERIMENTAL

LSM assessed by Elastographic Techniques

Device: LSM assessed by Elastographic Techniques

Interventions

LSM assessed by Elastographic Techniques 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

Patients undergoing HSCT

Eligibility Criteria

• Age: 3 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (37)

Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi.

Bologna, BO, Italy

Location

Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, Italy

Location

Azienda Ospedaliera "Card. G. Panico"

Tricase, Lecce, Italy

Location

Istituto Clinico Humanitas

Rozzano, Milano, Italy

Location

Policlinico Umberto I - Università la Sapienza

Roma, RM, Italy

Location

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

Alessandria, Italy

Location

Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona

Ancona, Italy

Location

Azienda Ospedaliero-Universitaria Consorziale - Policlinico di Bari

Bari, Italy

Location

ASST Papa Giovanni XXIII Ospedali riuniti di Bergamo

Bergamo, Italy

Location

Azienda Sanitaria dell'Alto Adige

Bolzano, Italy

Location

Spedali Civili di Brescia, UO Ematologia

Brescia, Italy

Location

Policlinico Vittorio Emanuele - Presidio Ferrarotto

Catania, Italy

Location

Azienda Ospedaliera-Universitaria Careggi

Florence, Italy

Location

Azienda Ospedaliera-Universitaria Meyer

Florence, Italy

Location

Ospedale Policlinico San Martino

Genova, Italy

Location

Ospedale Vito Fazzi

Lecce, Italy

Location

Ospedale dell'Angelo

Mestre, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

Location

Ospedale Maggiore Policlinico di Milano

Milan, Italy

Location

Ospedale San Raffaele

Milan, Italy

Location

Azienda Ospedaliera-Universitaria di Modena

Modena, Italy

Location

Ospedale Pediatrico Pausilipon

Napoli, Italy

Location

Policlinico Federico II

Napoli, Italy

Location

Azienda Ospedaliero-Universitaria di Padova

Padua, Italy

Location

Azienda Ospedaliera Ospedali riuniti Villa Sofia- Cervello

Palermo, Italy

Location

Azienda Ospedaliero-Universitaria Ospedale Maggiore di Parma

Parma, Italy

Location

Azienda Sanitaria Locale di Pescara

Pescara, Italy

Location

Azienda Ospedaliero-universitaria Pisana, UO Ematologia

Pisa, Italy

Location

Azienda Ospedaliero-Universitaria Pisana, UO Oncoematologia Pediatrica

Pisa, Italy

Location

Arcispedale S. Maria Nuova di Reggio Emilia

Reggio Emilia, Italy

Location

Ospedale Pediatrico Bambino Gesù

Roma, Italy

Location

Policlinico Tor Vergata

Roma, Italy

Location

Policlinico Universitario A. Gemelli

Roma, Italy

Location

Azienda Ospedaliero-Universitaria Città della Salute e della Scienza

Torino, Italy

Location

Azienda Ospedaliero-Universitaria Integrata di Udine

Udine, Italy

Location

Azienda Ospedaliero-Universitaria Integrata di Verona

Verona, Italy

Location

Azienda Ospedaliera di Vicenza

Vicenza, Italy

Location

Related Publications (26)

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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.

  PMID: 40253530 DERIVED

MeSH Terms

Conditions

Hepatic Veno-Occlusive Disease

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Antonio Colecchia, M.D.

  Azienda Ospedaliera-Universitaria Integrata di Verona

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (PI)

Model Details: All the patients with onco-hematological disease and an indication for transplantation of hematopoietic stem cells will be consecutively studied.

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 8, 2018
• Study Start: April 28, 2015
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

IT (37)