Spleen stiffness measurement: spleen stiffness measurement - during FibroScan
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* ≥18y
* 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
Exclusion Criteria:
* \<18y
* Contra-indication for transient elastography (Fibroscan®) such as ascites or overt heart failure.
Primary outcome measure(s)
Correlation between spleen stiffness measurement and biochemical assessment of severity of PBC. — 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 — 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 — 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. — 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 — 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
Trial sites (1)
Facility
City
Region
Status
UZ Brussel
Brussels
Belgium
More Universitair Ziekenhuis Brussel trials in Belgium
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
