Primary Biliary Cholangitis, Spleen Stiffness
Conditions
Keywords
spleen stiffness, primary biliairy cholangitis
Brief 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.
Interventions
PROCEDURESpleen stiffness measurement
spleen stiffness measurement - during FibroScan
Sponsors
Universitair Ziekenhuis Brussel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Belgium
Contacts
Primary ContactSilke François
Outcome results
None listed