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NCT Number: NCT07319169

The Value of Spleen Stiffness Measurement in Patients With PBC

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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Key information

Conditions

Primary Biliary Cholangitis Bile Duct Diseases Biliary Tract Diseases Cholestasis Cholestasis, Intrahepatic Digestive System Diseases Fibrosis Liver Cirrhosis Liver Cirrhosis, Biliary Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Spleen Stiffness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spleen stiffness measurement

Procedure

spleen stiffness measurement - during FibroScan

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)

  5. 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)

    liver or spleen stiffness measurement is done using FibroScan

Study contacts

Contact information is provided by the study sponsor or research team.

Silke François

CONTACT

[email protected]

+32 2 477 60 11

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 6, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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