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临床试验/NCT03426358
NCT03426358已完成不适用

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

IRCCS Azienda Ospedaliero-Universitaria di Bologna37 个研究点 分布在 1 个国家目标入组 1,101 人开始时间: 2015年4月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,101
试验地点
37
主要终点
Diagnostic Role of Liver Stiffness Measurement in SOS/VOD development

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
3 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • pathological obesity (BMI >40)
  • pacemaker of implantable defibrillator
  • presence of ascites at baseline

结局指标

主要结局

Diagnostic Role of Liver Stiffness Measurement in SOS/VOD development

时间窗: From HSCT to 30 days after HSCT

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Davide Festi

Principal Investigator (PI)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

研究点 (37)

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