The Value of Spleen Stiffness Measurement in Patients With PBC

Universitair Ziekenhuis Brussel

Status: Not yet enrolling

Conditions: Primary Biliary Cholangitis; Spleen Stiffness

Treatments: Procedure: Spleen stiffness measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT07319169

VasMe PBC

Details and patient eligibility

About

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.

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥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 criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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125 participants in 1 patient group

Spleen stiffness measurement

Experimental group

Treatment:

Procedure: Spleen stiffness measurement