The Value of Spleen Stiffness Measurement in Patients With PBC

NCT07319169 — Not applicable, Not yet recruiting, 125 participants, Universitair Ziekenhuis Brussel

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Registry	NCT07319169
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, diagnostic
Enrollment	125 (Estimated)
Sponsor	Universitair Ziekenhuis Brussel (Other)
Conditions	Primary Biliary Cholangitis, Spleen Stiffness
Interventions	Spleen stiffness measurement (Procedure)
Dates	start 2026-07-01 (estimated), primary completion 2028-01-01 (estimated), completion 2028-01-01 (estimated), first posted 2026-01-06, last updated 2026-05-01
Locations	1 site in Belgium

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Spleen stiffness measurement	Experimental	Procedure: Spleen stiffness measurement

Spleen stiffness measurement (Procedure): spleen stiffness measurement - during FibroScan

+Outcome measures

Primary outcomes

Correlation between spleen stiffness measurement and biochemical assessment of severity of PBC. [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 [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 [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. [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 [from signing the ICF till end of study (could be up to 5 years, assessments are done every 6 months)]: liver or spleen stiffness measurement is done using FibroScan

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
UZ Brussel	Brussels	Belgium