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

Stem Cell Transplant Complications Clinical Trial

— ELASTOVOD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03426358
• Other study ID #: ELASTOVOD
• Status: Completed
• Phase: N/A
• Start date: April 28, 2015
• Est. completion date: December 2021

Study information

• Verified date: April 2022
• Source: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1101
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
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 Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi.	Bologna	BO
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	Firenze
Italy	Azienda Ospedaliera-Universitaria Meyer	Firenze
Italy	Ospedale Policlinico San Martino	Genova
Italy	Ospedale Vito Fazzi	Lecce
Italy	Ospedale dell'Angelo	Mestre
Italy	ASST Grande Ospedale Metropolitano Niguarda	Milano
Italy	Ospedale Maggiore Policlinico di Milano	Milano
Italy	Ospedale San Raffaele	Milano
Italy	Azienda Ospedaliera-Universitaria di Modena	Modena
Italy	Ospedale Pediatrico Pausilipon	Napoli
Italy	Policlinico Federico II	Napoli
Italy	Azienda Ospedaliero-Universitaria di Padova	Padova
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 Umberto I - Università la Sapienza	Roma	RM
Italy	Policlinico Universitario A. Gemelli	Roma
Italy	Istituto Clinico Humanitas	Rozzano	Milano
Italy	Casa Sollievo della Sofferenza	San Giovanni Rotondo	Foggia
Italy	Azienda Ospedaliero-Universitaria Città della Salute e della Scienza	Torino
Italy	Azienda Ospedaliera "Card. G. Panico"	Tricase	Lecce
Italy	Azienda Ospedaliero-Universitaria Integrata di Udine	Udine
Italy	Azienda Ospedaliero-Universitaria Integrata di Verona	Verona
Italy	Azienda Ospedaliera di Vicenza	Vicenza

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Study Website