The Value of Spleen Stiffness Measurement in Patients With PBC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spleen stiffness measurement.
- Who it may be relevant to
- Registry conditions: Primary Biliary Cholangitis, Spleen Stiffness. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Interventions
- Procedure Spleen stiffness measurement
spleen stiffness measurement - during FibroScan
Primary outcome measures
- 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)]
- 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)]
- 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)]
- 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)]
- Evaluation of the evolution of liver or spleen stiffness on treatment of PBC [Time frame: from signing the ICF till end of study (could be up to 5 years, assessments are done every 6 months)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Belgium · 1 center
- UZ Brussel — Brussels
Identifiers
NCT: NCT07319169 · VasMe PBC