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<p>Hepatic Veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS) is a severe complication following hematopoietic stem cell transplantation (HSCT), traditionally diagnosed based on clinical criteria. This study aimed to evaluate the diagnostic performance of liver stiffness measurement (LSM) as a non-invasive tool for non invasive diagnosis of VOD/SOS. A multicentre clinical trial was conducted in Italy from April 2018 to December 2021, screening 1089 patients across 25 centers. VOD/SOS diagnosis followed established clinical guidelines, and patients underwent comprehensive clinical, laboratory, and imaging evaluations up to +100 days post-HSCT or until VOD/SOS diagnosis. LSM was measured pre-HSCT and on specific post-transplant days (ClinicalTrials.gov: NCT03426358). The study enrolled 774 adults and 167 children. The +100-day incidence of VOD/SOS HSCT was 5.53 and 5.26 in the overall and allo-HSCT population, higher in children (14.3%) than in adults (3.68%). The 100-day overall survival (OS) probability was 89.5% (overall) and 89.0% (allo-HSCT) while one-yr OS 79% and 78%, respectively, with outcomes varying by VOD/SOS occurrence and severity. LSM significantly differed between VOD/SOS patients and non-affected individuals at all post-HSCT time points, correlating with disease severity. A diagnostic algorithm was proposed, achieving ≥95% sensitivity and specificity, with a 6 kPa rule-out and 25 kPa rule-in cut-off, enhanced by the “three-time pre-HSCT rule.” Survivors showed declining LSM over time, while non-survivors did not. Fully recovered patients had lower LSM than non-improvers. LSM also distinguished VOD/SOS from other liver complications within +100 days post-HSCT in both adults and children. In conclusion, LSM is a reliable, non-invasive diagnostic tool for VOD/SOS. LSM contribute to differential diagnosis and to treatment response as well. This study underscores the potential of LSM, combined with multidisciplinary expertise, to guide VOD/SOS diagnosis and management in HSCT patients, improving potentially the clinical outcomes.</p>

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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

  • 期刊论文

  • 发表日期：

    2025年4月19日

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  • Federico Ravaioli,
  • Antonio Colecchia,
  • Jacopo Peccatori,
  • Daria Pagliara,
  • Anna Grassi,
  • Francesco Barbato,
  • Riccardo Masetti,
  • Barbara Sarina,
  • Simona Sica,
  • Simone Cesaro,
  • Chiara Nozzoli,
  • Giovanni Manfredi Assanto,
  • Lucia Prezioso,
  • Stella Santarone,
  • Francesco Saglio,
  • Ester Vanni,
  • Attilio Olivieri,
  • Mario Delia,
  • Edoardo Benedetti,
  • Francesco Zallio,
  • Fabrizio Pane,
  • Cristina Skert,
  • Mariacristina Menconi,
  • Fabio Benedetti,
  • Francesco De Felice,
  • Luigi Colecchia,
  • Tamara Belotti,
  • Luigina Vanessa Alemanni,
  • Margherita Ursi,
  • Giovanni Marasco,
  • Marcello Roberto,
  • Amanda Vestito,
  • Elton Dajti,
  • Matteo Garcovich,
  • Stefania Bramanti,
  • Daniela Taurino,
  • Francesco Quagliarella,
  • Fabio Ciceri,
  • Arcangelo Prete,
  • Andrea Pession,
  • Davide Festi,
  • Mario Arpinati,
  • Enrico Maffini,
  • Sadia Falcione,
  • Rocco Maurizio Zagari,
  • Zama Daniele,
  • Lorenzo Lazzari,
  • Alessandro Rambaldi,
  • Laura Riccardi,
  • Valentina Di Ruscio,
  • Emilia Boccieri,
  • Margherita Falcomer,
  • Valsania Chiara,
  • Virginia Vitale,
  • Chiara Garonzi,
  • Francesco Vizzutti,
  • Umberto Arena,
  • Adriano De Santis,
  • Amelia RinaldI,
  • Andrea Olivani,
  • Doriana Vaddinelli,
  • Enza Di Lembo,
  • Manuela Spadea,
  • Vincenzo Apolito,
  • Dellacasa Chiara,
  • Alessandro Busca,
  • Giorgia Mancini,
  • Giulio Argalia,
  • Paola Carluccio,
  • Francesca Passerini,
  • Alessandro Di Gangi,
  • Paolo Rivela,
  • Roberto Carbone,
  • Giorgia Battipaglia,
  • Francesca Carobolante,
  • Irene Franceschet,
  • Francesca Patriarca,
  • Michele Malagola,
  • Riccardo Varaldo,
  • Francesco Onida,
  • Pavone Vincenzo,
  • Fancesca Bonifazi,
  • Francesca Bonifazi

摘要

Hepatic Veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS) is a severe complication following hematopoietic stem cell transplantation (HSCT), traditionally diagnosed based on clinical criteria. This study aimed to evaluate the diagnostic performance of liver stiffness measurement (LSM) as a non-invasive tool for non invasive diagnosis of VOD/SOS. A multicentre clinical trial was conducted in Italy from April 2018 to December 2021, screening 1089 patients across 25 centers. VOD/SOS diagnosis followed established clinical guidelines, and patients underwent comprehensive clinical, laboratory, and imaging evaluations up to +100 days post-HSCT or until VOD/SOS diagnosis. LSM was measured pre-HSCT and on specific post-transplant days (ClinicalTrials.gov: NCT03426358). The study enrolled 774 adults and 167 children. The +100-day incidence of VOD/SOS HSCT was 5.53 and 5.26 in the overall and allo-HSCT population, higher in children (14.3%) than in adults (3.68%). The 100-day overall survival (OS) probability was 89.5% (overall) and 89.0% (allo-HSCT) while one-yr OS 79% and 78%, respectively, with outcomes varying by VOD/SOS occurrence and severity. LSM significantly differed between VOD/SOS patients and non-affected individuals at all post-HSCT time points, correlating with disease severity. A diagnostic algorithm was proposed, achieving ≥95% sensitivity and specificity, with a 6 kPa rule-out and 25 kPa rule-in cut-off, enhanced by the “three-time pre-HSCT rule.” Survivors showed declining LSM over time, while non-survivors did not. Fully recovered patients had lower LSM than non-improvers. LSM also distinguished VOD/SOS from other liver complications within +100 days post-HSCT in both adults and children. In conclusion, LSM is a reliable, non-invasive diagnostic tool for VOD/SOS. LSM contribute to differential diagnosis and to treatment response as well. This study underscores the potential of LSM, combined with multidisciplinary expertise, to guide VOD/SOS diagnosis and management in HSCT patients, improving potentially the clinical outcomes.