A Prospective Study on IVUS and DSA Guidance in the Treatment of Budd-Chiari Syndrome (NCT06960473) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Prospective Study on IVUS and DSA Guidance in the Treatment of Budd-Chiari Syndrome
China260 participantsStarted 2025-05-18
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of Restenosis
Timeframe: Follow-up and assessment will be conducted at 1 month, 3 months, 6 months, and 12 months post-surgery.
Trial details
NCT IDNCT06960473
SponsorThe Affiliated Hospital of Xuzhou Medical University