The Value of Spleen Stiffness Measurement in Patients With PBC

NCT ID: NCT07319169

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2028-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Biliary Cholangitis Spleen Stiffness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Spleen stiffness measurement

Group Type EXPERIMENTAL

Spleen stiffness measurement

Intervention Type PROCEDURE

spleen stiffness measurement - during FibroScan

Interventions

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Spleen stiffness measurement

spleen stiffness measurement - during FibroScan

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UZ Brussel

Brussels, , Belgium

Site Status

Countries

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Belgium

Central Contacts

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Silke François

Role: CONTACT

+32 2 477 60 11

Facility Contacts

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Silke François

Role: primary

+32 2 477 60 11

Other Identifiers

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VasMe PBC

Identifier Type: -

Identifier Source: org_study_id

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