A Prospective Study on IVUS and DSA Guidance in the Treatment of Budd-Chiari Syndrome

NCT06960473 · tracked via the Priya Life Science China tracker

Sponsor

The Affiliated Hospital of Xuzhou Medical University

Phase

Not applicable

Started

2025-05-18

Last updated

2025-05-07

Condition(s) studied

Budd-Chiari Syndrome

Investigational drug(s) / intervention(s)

Intravascular UltrasoundDigital Subtraction Angiography

Intravascular Ultrasound: In the IVUS group, the diameter of the reference vessel (the normal segment of the artery distal to the occlusion) is measured using Intravascular Ultrasound (IVUS). Based on the IVUS measurements, an appropriate balloon is selected to dilate the occluded segment.

Digital Subtraction Angiography: The DSA group patients will have the appropriate balloon dilation selected for the occluded segment based on the DSA measurement results.

Study 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 Syndrome (BCS). Using a prospective, randomized controlled trial design, patients who meet the diagnostic criteria for BCS and are suitable for interventional treatment are randomly divided into the IVUS group and the DSA group. The IVUS group will undergo detailed assessment of vascular structure before interventional treatment to select the appropriate balloon for dilation, whereas the control group will make decisions based on DSA results. The primary endpoint of the study is the postoperative restenosis rate, while secondary endpoints include complications of interventional treatment, liver function, and patient survival rate. Successful implementation of this study will provide new technical means to optimize interventional treatment strategies for BCS, and help improve treatment outcomes and long-term prognosis for patients.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * 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 Criteria: * 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.

Primary outcome measure(s)

Rate of Restenosis — Follow-up and assessment will be conducted at 1 month, 3 months, 6 months, and 12 months post-surgery.
At the 1 month, 3 months, 6 months, and 12 months follow-up after surgery, vascular patency will be assessed through imaging examinations such as ultrasound, CT, or MRI, and the incidence of restenosis will be recorded to compare the treatment outcomes between the IVUS group and the DSA group

Trial sites (1)

Facility	City	Region	Status
Department of Interventional Radiology, the Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06960473 on ClinicalTrials.gov ↗ ← All trials in China