Clinical Trial

The Value of Spleen Stiffness Measurement in Patients With PBC

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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-12-19.
Trial Details
NCT Number NCT07319169
Lead Sponsor Universitair Ziekenhuis Brussel
Conditions Primary Biliary Cholangitis, Spleen Stiffness
Enrollment 125 participants
Start Date 2026-07
Primary Completion 2028-01 (estimated)
Study Completion 2028-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-01