Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 9:07 AM
Study NCT ID:
NCT07319169
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-06
First Post:
2025-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Value of Spleen Stiffness Measurement in Patients With PBC
Sponsor:
Universitair Ziekenhuis Brussel
Organization:
Study Overview
Official Title:
The Value of Spleen Stiffness Measurement in Patients With PBC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: