The Value of Spleen Stiffness Measurement in Patients With PBC

Starting soon · Not applicable

Conditions studied: Primary Biliary Cholangitis, Spleen Stiffness

In brief

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.

Key facts

Study ID

NCT07319169

Run by

Universitair Ziekenhuis Brussel

People needed

125

Starts

2026-07-01

Expected to finish

2028-01-01

Last updated by the study team

2026-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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

You may not qualify if…

• <18y
• Contra-indication for transient elastography (Fibroscan®) such as ascites or overt heart failure.

Where it is running

• UZ Brussel — Brussels, Belgium

Full record on ClinicalTrials.gov

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