Spleen stiffness measurement in patients with primary biliary cholangitis
Tests spleen stiffness measurement, alongside routine checkups, in adults with primary biliary cholangitis.
Key facts
- Who runs it
- Universitair Ziekenhuis Brussel
- Where
- Brussels, BelgiumSee the site
- Trial code
- Registry title
- The Value of Spleen Stiffness Measurement in Patients With PBC
- Status
- Not yet recruiting
- People taking part
- 125 people, planned
- Started
- Jul 2026
- Expected to end
- Jan 2028
- Type of study
- Interventional
- Treatments tested
- Spleen stiffness measurement
- Record updated
- 1 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with primary biliary cholangitis (PBC) who are followed as outpatients at UZ Brussels and take ursodeoxycholic acid and/or bezafibrate. It tests spleen stiffness measurement during their routine FibroScan.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- PBC diagnosed from cholestasis, AMA positivity and/or a biopsy.
- Earlier treatment
- Must be treated with ursodeoxycholic acid and/or bezafibrate.
- Biomarker or test result
- AMA positivity and/or a biopsy is part of the PBC diagnosis.
Main reasons for not taking part
- Younger than 18 years
- Cannot have a FibroScan (transient elastography), for example because of ascites or overt heart failure
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- ≥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
Who cannot take part
- Contra-indication for transient elastography (Fibroscan®) such as ascites or overt heart failure
- <18y
Where in Belgium
- UZ BrusselBrussels, BelgiumContact: Silke FrançoisNo longer taking part
About the trial
What the trial wants to find out
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.
The group in the trial
- Spleen stiffness measurementTreatment being tested
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Value of Spleen Stiffness Measurement in Patients With PBC
- Plain-language title
- Spleen stiffness measurement in patients with primary biliary cholangitisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 1 May 2026