Liver Stiffness Measurement Predicts VOD/SOS Development (ELASTOVOD ITALIAN MULTICENTRIC STUDY)
Condition: Veno Occlusive Disease, Hepatic; Sinusoidal Obstruction Syndrome; Stem Cell Transplant Complications
MeSH terms: Hepatic Veno-Occlusive Disease; Syndrome
Study type: Interventional

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.
    

Intervention name(s): LSM assessed by Elastographic Techniques
Intervention type(s): Device
Intervention description(s): 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
Intervention model: Single Group Assignment
Intervention model description: All the patients with onco-hematological disease and an indication for transplantation of hematopoietic stem cells will be consecutively studied.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Veno Occlusive Disease; Sinusoidal Obstruction Syndrome; HSCT; Hematopoietic Stem Cell Transplantation; Stem Cell Transplant Complications; Liver Stiffness Measurement; Sinusoidal Obstructive Syndrome; Transient Elastography