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.
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Correlation between spleen stiffness measurement and biochemical assessment of severity of PBC.
Timeframe: 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 clinical signs of portal hypertension, liver related events and PH-related bleeding
Timeframe: 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
Timeframe: 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.
Timeframe: 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
Timeframe: from signing the ICF till end of study (could be up to 5 years, assessments are done every 6 months)