NCT07319169

The Value of Spleen Stiffness Measurement in Patients With PBC

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Biliary Cholangitis
• Spleen Stiffness

Interventions

Type	Name	Description
PROCEDURE	Spleen stiffness measurement	spleen stiffness measurement - during FibroScan

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2026-01-06
• Last updated: 2026-01-06

Locations

1 site across 1 country: Belgium