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NCT07319169Not yet recruiting

The Value of Spleen Stiffness Measurement in Patients With PBC

Source: ClinicalTrials.gov · Last updated 1 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
125 (estimated)
First submitted
5 Dec 2025
Start date
1 Jul 2026
Primary completion date
31 Jan 2028
Lead sponsor
Universitair Ziekenhuis Brussel
NCT number
NCT07319169

What you commit to

  • Study type: Interventional
  • Planned participants: 125
  • From 1 Jul 2026 to the primary completion date, 31 Jan 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

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

Other

  • \<18y

Who the study is looking for

  • ≥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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UZ Brussel
Coordinator of this site? Confirm its status
BrusselsBelgiumUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.