Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spleen stiffness measurement | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spleen stiffness measurement | Procedure | spleen stiffness measurement - during FibroScan |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Silke François | Contact | +32 2 477 60 11 | silke.francois@uzbrussel.be |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussel | Brussels | 1090 | Belgium |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008105 | Liver Cirrhosis, Biliary |
| ID | Term |
|---|---|
| D002780 | Cholestasis, Intrahepatic |
| D002779 | Cholestasis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D004066 |
| Digestive System Diseases |
| D008107 | Liver Diseases |
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |