The Value of Spleen Stiffness Measurement in Patients With PBC
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Correlation between spleen stiffness measurement and clinical signs of portal hypertension, liver related events and PH-related bleeding
研究概览
简要总结
Recent evidence suggests that combining liver stiffness measurement (LSM) with spleen stiffness measurement (SSM) significantly improves risk stratification in patients with PBC. In a study the addition of spleen stiffness to liver stiffness enhanced the prediction of liver decompensation, providing a more precise evaluation of portal hypertension. Furthermore, when combined with platelet count, this approach effectively identified patients with a low probability of harboring HRVs. This could allow clinicians to safely avoid unnecessary endoscopic procedures in selected patients, improving patient comfort and reducing healthcare costs. Therefore, our patients participating in this trial will undergo follow up (every 6 months) as per Standard of care. This includes a blood draw, FibroScan and Ultrasound. Together with this, 2 questionnaires will be completed (not as per SOC) and during the FibroScan, a spleen stiffness measurement will be performed.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Out-patient, followed at the UZ Brussels
- •Diagnosis of PBC based on cholestasis, AMA positivity and/or biopsy.
- •Under treatment with ursodeoxycholic acid and/or bezafibrate
排除标准
- •Contra-indication for transient elastography (Fibroscan®) such as ascites or overt heart failure.
研究组 & 干预措施
Spleen stiffness measurement
干预措施: Spleen stiffness measurement (Procedure)
结局指标
主要结局
Correlation between spleen stiffness measurement and clinical signs of portal hypertension, liver related events and PH-related bleeding
时间窗: from signing the ICF till end of study (could be up to 5 years, assessments are done every 6 months)
Correlation between spleen stiffness measurement and biochemical assessment of severity of PBC.
时间窗: from signing the ICF till end of study (could be up to 5 years, assessments are done every 6 months)
Correlation between spleen stiffness measurement and quality of life assessment of severity of PBC.
时间窗: from signing the ICF till end of study (could be up to 5 years, assessments are done every 6 months)
Correlation between spleen stiffness measurement and endoscopic signs of portal hypertension, liver related events and PH-related bleeding
时间窗: from signing the ICF till end of study (could be up to 5 years, assessments are done every 6 months)
Evaluation of the evolution of liver or spleen stiffness on treatment of PBC
时间窗: from signing the ICF till end of study (could be up to 5 years, assessments are done every 6 months)
liver or spleen stiffness measurement is done using FibroScan
次要结局
未报告次要终点