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Spleen stiffness measurement in patients with primary biliary cholangitis

Tests spleen stiffness measurement, alongside routine checkups, in adults with primary biliary cholangitis.

Plain-language title generated from the registry record
Registry title: The Value of Spleen Stiffness Measurement in Patients With PBC

Key facts

Where
Brussels, BelgiumSee the site

Where in Belgium

  • UZ BrusselBrussels, BelgiumNo longer taking part

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Trial details

Who runs it
Universitair Ziekenhuis Brussel
Trial code
NCT07319169
Record updated
1 May 2026
Original description
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.Read full original descriptionShow less

The Value of Spleen Stiffness Measurement in Patients With PBC

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.

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

ClinicalTrials.gov NCT07319169