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
This trial does not accept healthy volunteersQualifiers
≥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
Design model
Single group
Treatments tested in this trial
Spleen stiffness measurement
Procedure/Surgeryspleen stiffness measurement - during FibroScan
Treatment groups
125 Participants
are divided into 1 treatment groupGroup A: Spleen stiffness measurementExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Correlation between spleen stiffness measurement and biochemical assessment of severity of PBC.
Time frame
from signing the ICF till end of study (could be up to 5 years, assessments are done every 6 months)2
Correlation between spleen stiffness measurement and clinical signs of portal hypertension, liver related events and PH-related bleeding
Time frame
from signing the ICF till end of study (could be up to 5 years, assessments are done every 6 months)3
Correlation between spleen stiffness measurement and endoscopic signs of portal hypertension, liver related events and PH-related bleeding
Time frame
from signing the ICF till end of study (could be up to 5 years, assessments are done every 6 months)4
Correlation between spleen stiffness measurement and quality of life assessment of severity of PBC.
Time frame
from signing the ICF till end of study (could be up to 5 years, assessments are done every 6 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: