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

Not Applicable

Completed

• Conditions: Veno Occlusive Disease, Hepatic; Sinusoidal Obstruction Syndrome; Stem Cell Transplant Complications
• Interventions: Device: LSM assessed by Elastographic Techniques

• Registration Number: NCT03426358
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Timeline

• Study Start: 2015-04-28
• Study First Submitted: 2018-02-02
• Study First Submitted QC: 2018-02-02
• Study First Posted: 2018-02-08
• Primary Completion: 2021-12
• Study Completion: 2021-12
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-13
• Last Update Posted: 2022-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1101

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients undergoing HSCT	LSM assessed by Elastographic Techniques	LSM assessed by Elastographic Techniques

Primary Outcome Measures

Name	Time	Method
Diagnostic Role of Liver Stiffness Measurement in SOS/VOD development	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.

Trial Locations

Locations (37)

Azienda Ospedaliera "Card. G. Panico"; 🇮🇹 Tricase, Lecce, Italy

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Milano, 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

Ospedale Policlinico San Martino; 🇮🇹 Genova, Italy

Spedali Civili di Brescia, UO Ematologia; 🇮🇹 Brescia, Italy

Azienda Ospedaliera-Universitaria Meyer; 🇮🇹 Firenze, Italy

Ospedale dell'Angelo; 🇮🇹 Mestre, Italy

Ospedale Maggiore Policlinico di Milano; 🇮🇹 Milano, Italy

Azienda Ospedaliera-Universitaria di Modena; 🇮🇹 Modena, Italy

Azienda Sanitaria Locale di Pescara; 🇮🇹 Pescara, Italy

Azienda Ospedaliera di Vicenza; 🇮🇹 Vicenza, Italy

Azienda Ospedaliera-Nazionale SS. Antonio e Biagio e Cesare Arrigo; 🇮🇹 Alessandria, Italy

Azienda Sanitaria dell'Alto Adige; 🇮🇹 Bolzano, Italy

Azienda Ospedaliera-Universitaria Careggi; 🇮🇹 Firenze, Italy

Ospedale Vito Fazzi; 🇮🇹 Lecce, Italy

Ospedale San Raffaele; 🇮🇹 Milano, Italy

ASST Grande Ospedale Metropolitano Niguarda; 🇮🇹 Milano, Italy

Ospedale Pediatrico Pausilipon; 🇮🇹 Napoli, Italy

Policlinico Federico II; 🇮🇹 Napoli, Italy

Azienda Ospedaliero-Universitaria Ospedale Maggiore di Parma; 🇮🇹 Parma, Italy

Policlinico Universitario A. Gemelli; 🇮🇹 Roma, Italy

Azienda Ospedaliero-Universitaria Integrata di Udine; 🇮🇹 Udine, Italy

Azienda Ospedaliero-Universitaria di Padova; 🇮🇹 Padova, Italy

Azienda Ospedaliero-Universitaria Pisana, UO Oncoematologia Pediatrica; 🇮🇹 Pisa, Italy

Azienda Ospedaliero-Universitaria Città della Salute e della Scienza; 🇮🇹 Torino, Italy

Azienda Ospedaliera Ospedali riuniti Villa Sofia- Cervello; 🇮🇹 Palermo, Italy

Arcispedale S. Maria Nuova di Reggio Emilia; 🇮🇹 Reggio Emilia, Italy

Azienda Ospedaliero-Universitaria Integrata di Verona; 🇮🇹 Verona, Italy

Ospedale Pediatrico Bambino Gesù; 🇮🇹 Roma, Italy

Policlinico Tor Vergata; 🇮🇹 Roma, Italy

Casa Sollievo della Sofferenza; 🇮🇹 San Giovanni Rotondo, Foggia, Italy

Policlinico Vittorio Emanuele - Presidio Ferrarotto; 🇮🇹 Catania, Italy

Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi.; 🇮🇹 Bologna, BO, Italy

Policlinico Umberto I - Università la Sapienza; 🇮🇹 Roma, RM, Italy

Azienda Ospedaliero-universitaria Pisana, UO Ematologia; 🇮🇹 Pisa, Italy