The Value of Spleen Stiffness Measurement in Patients With PBC

NCT07319169 | Not Yet Recruiting

• 1 other identifier: VasMe PBC
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spleen Stiffness; Primary Biliary Cholangitis

Keywords

spleen stiffness; primary biliairy cholangitis

Outcome Measures

Primary Outcomes (5)

• 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

  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)

Study Arms (1)

Spleen stiffness measurement

EXPERIMENTAL

Procedure: Spleen stiffness measurement

Interventions

Spleen stiffness measurement PROCEDURE

spleen stiffness measurement - during FibroScan

Spleen stiffness measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• \<18y
• Contra-indication for transient elastography (Fibroscan®) such as ascites or overt heart failure.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Brussels, 1090, Belgium

Location

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Silke François

CONTACT

+32 2 477 60 11; silke.francois@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: January 6, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)