Status:
NOT_YET_RECRUITING
A Prospective Study on IVUS and DSA Guidance in the Treatment of Budd-Chiari Syndrome
Lead Sponsor:
The Affiliated Hospital of Xuzhou Medical University
Conditions:
Budd-Chiari Syndrome
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This study aims to evaluate the effectiveness of interventional treatment guided by Intravascular Ultrasound (IVUS) compared to Digital Subtraction Angiography (DSA) in patients with Budd-Chiari Syndr...
Detailed Description
This study aims to establish a precise interventional diagnostic and therapeutic system for Budd-Chiari Syndrome (BCS) based on IVUS assistance by comparing it with conventional DSA-guided diagnosis a...
Eligibility Criteria
Inclusion
- Age between 18 and 75 years.
- Primary Budd-Chiari Syndrome (narrowing or occlusion of the inferior vena cava near the hepatic veins or hepatic vein openings).
- Presence of membrane or short segment stenosis or occlusion suitable for balloon dilation (≤ 5 cm).
- Child-Pugh score less than 13.
- The patient or their authorized family member signs an informed consent form, voluntarily participating in the study and agreeing to follow-up.
Exclusion
- Prior interventional treatment.
- Unfit for balloon dilation or stent placement (e.g., diffuse obstruction of the hepatic veins recommended for TIPS treatment, end-stage liver disease recommended for liver transplantation, etc.).
- Coexisting severe heart disease (such as heart failure, severe arrhythmias), liver or kidney failure, severe infections, iodinated contrast agent allergy.
- Coexisting hepatocellular carcinoma or other malignant tumors.
- Pregnant or breastfeeding women.
- Patients with a life expectancy of less than 1 year.
- Patients unable to complete follow-up or cooperate with the study.
Key Trial Info
Start Date :
May 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT06960473
Start Date
May 18 2025
End Date
December 31 2026
Last Update
May 7 2025
Active Locations (1)
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1
Department of Interventional Radiology, the Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221000