The Value of Spleen Stiffness Measurement in Patients With PBC

N/ANot Yet RecruitingNCT07319169

Universitair Ziekenhuis Brussel125 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

125

Conditions

Primary Biliary Cholangitis Spleen Stiffness

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.