The Value of Spleen Stiffness Measurement in Patients With PBC

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitair Ziekenhuis Brussel

About this trial

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.

Eligibility criteria

Qualifiers

≥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

Disqualifiers

<18y

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

Trial design

Treatments tested in this trial

  • Spleen stiffness measurement

Treatment groups

125 Participants
are divided into 1 treatment group