Clinical trial NCT03426358: Liver Stiffness Measurement Predicts VOD/SOS Development (ELASTOVOD ITALIAN MULTICENTRIC STUDY)
Official title: Usefulness of Liver Stiffness Measurement in Predicting Hepatic Veno-Occlusive Disease Development in Patients Who Undergo HSCT: a Multicentric Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2018-02-08
Enrollment: 1101
Sex: ALL
Minimum age (years): 3
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All the patients with onco-hematological disease and an indication for transplantation of hematopoietic stem cells will be consecutively studied.
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Diagnostic Role of Liver Stiffness Measurement in SOS/VOD development
timeFrame: From HSCT to 30 days after HSCT
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi.
state: BO
city: San Giovanni Rotondo
country: Italy
facility: Casa Sollievo della Sofferenza
state: Foggia
city: Tricase
country: Italy
facility: Azienda Ospedaliera "Card. G. Panico"
state: Lecce
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: Roma
country: Italy
facility: Policlinico Umberto I - Università la Sapienza
state: RM
city: Alessandria
country: Italy
facility: Azienda Ospedaliera-Nazionale SS. Antonio e Biagio e Cesare Arrigo
city: Ancona
country: Italy
facility: Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona
city: Bari
country: Italy
facility: Azienda Ospedaliero-Universitaria Consorziale - Policlinico di Bari
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII Ospedali riuniti di Bergamo
city: Bolzano
country: Italy
facility: Azienda Sanitaria dell'Alto Adige
city: Brescia
country: Italy
facility: Spedali Civili di Brescia, UO Ematologia
city: Catania
country: Italy
facility: Policlinico Vittorio Emanuele - Presidio Ferrarotto
city: Firenze
country: Italy
facility: Azienda Ospedaliera-Universitaria Careggi
city: Firenze
country: Italy
facility: Azienda Ospedaliera-Universitaria Meyer
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi
city: Mestre
country: Italy
facility: Ospedale dell'Angelo
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
city: Milano
country: Italy
facility: Ospedale Maggiore Policlinico di Milano
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Modena
country: Italy
facility: Azienda Ospedaliera-Universitaria di Modena
city: Napoli
country: Italy
facility: Ospedale Pediatrico Pausilipon
city: Napoli
country: Italy
facility: Policlinico Federico II
city: Padova
country: Italy
facility: Azienda Ospedaliero-Universitaria di Padova
city: Palermo
country: Italy
facility: Azienda Ospedaliera Ospedali riuniti Villa Sofia- Cervello
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria Ospedale Maggiore di Parma
city: Pescara
country: Italy
facility: Azienda Sanitaria Locale di Pescara
city: Pisa
country: Italy
facility: Azienda Ospedaliero-universitaria Pisana, UO Ematologia
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana, UO Oncoematologia Pediatrica
city: Reggio Emilia
country: Italy
facility: Arcispedale S. Maria Nuova di Reggio Emilia
city: Roma
country: Italy
facility: Ospedale Pediatrico Bambino Gesù
city: Roma
country: Italy
facility: Policlinico Tor Vergata
city: Roma
country: Italy
facility: Policlinico Universitario A. Gemelli
city: Torino
country: Italy
facility: Azienda Ospedaliero-Universitaria Città della Salute e della Scienza
city: Udine
country: Italy
facility: Azienda Ospedaliero-Universitaria Integrata di Udine
city: Verona
country: Italy
facility: Azienda Ospedaliero-Universitaria Integrata di Verona
city: Vicenza
country: Italy
facility: Azienda Ospedaliera di Vicenza
Study officials:
affiliation: Azienda Ospedaliera-Universitaria Integrata di Verona
name: Antonio Colecchia, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliera-Universitaria Sant'Orsola Malpighi di Bologna
name: Francesca Bonifazi, Ph.D. M.D.
role: STUDY_CHAIR
affiliation: Azienda Ospedaliera-Universitaria Sant'Orsola Malpighi di Bologna
name: Andrea Passion, Prof. M.D.
role: STUDY_CHAIR
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