The Value of Spleen Stiffness Measurement in Patients With PBC

April 30, 2026 updated by: Universitair Ziekenhuis Brussel
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Spleen stiffness measurement
Procedure: Spleen stiffness measurement
spleen stiffness measurement - during FibroScan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
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)
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)
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)
liver or spleen stiffness measurement is done using FibroScan
from signing the ICF till end of study (could be up to 5 years, assessments are done every 6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

December 5, 2025

First Submitted That Met QC Criteria

December 19, 2025

First Posted (Actual)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VasMe PBC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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