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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing HSCT | Experimental | LSM assessed by Elastographic Techniques |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi. | Bologna | BO | Italy | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14564177 | Background | Wadleigh M, Ho V, Momtaz P, Richardson P. Hepatic veno-occlusive disease: pathogenesis, diagnosis and treatment. Curr Opin Hematol. 2003 Nov;10(6):451-62. doi: 10.1097/00062752-200311000-00010. | |
| 20373370 | Background | McDonald GB. Hepatobiliary complications of hematopoietic cell transplantation, 40 years on. Hepatology. 2010 Apr;51(4):1450-60. doi: 10.1002/hep.23533. |
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All the patients with onco-hematological disease and an indication for transplantation of hematopoietic stem cells will be consecutively studied.
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| 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 | Naples | Italy |
| Policlinico Federico II | Naples | 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 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 |
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| 25798682 | Background | Mohty M, Malard F, Abecassis M, Aerts E, Alaskar AS, Aljurf M, Arat M, Bader P, Baron F, Bazarbachi A, Blaise D, Ciceri F, Corbacioglu S, Dalle JH, Duarte RF, Fukuda T, Huynh A, Masszi T, Michallet M, Nagler A, NiChonghaile M, Pagluica T, Peters C, Petersen FB, Richardson PG, Ruutu T, Savani BN, Wallhult E, Yakoub-Agha I, Carreras E. Sinusoidal obstruction syndrome/veno-occlusive disease: current situation and perspectives-a position statement from the European Society for Blood and Marrow Transplantation (EBMT). Bone Marrow Transplant. 2015 Jun;50(6):781-9. doi: 10.1038/bmt.2015.52. Epub 2015 Mar 23. |
| 27941774 | Background | Colecchia A, Marasco G, Ravaioli F, Kleinschmidt K, Masetti R, Prete A, Pession A, Festi D. Usefulness of liver stiffness measurement in predicting hepatic veno-occlusive disease development in patients who undergo HSCT. Bone Marrow Transplant. 2017 Mar;52(3):494-497. doi: 10.1038/bmt.2016.320. Epub 2016 Dec 12. No abstract available. |
| 40253530 | Derived | 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. |
| ID | Term |
|---|---|
| D006504 | Hepatic Veno-Occlusive Disease |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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