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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe Affiliated Hospital of Xuzhou Medical University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intravascular Ultrasound

    Device

    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

    Device

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

Treatment groups

260 Participants
are divided into 2 treatment groups
Group A: IVUS GroupExperimental treatment 1 intervention
Group B: DSA GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate of Restenosis

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

Time frame
Follow-up and assessment will be conducted at 1 month, 3 months, 6 months, and 12 months post-surgery.

Secondary outcomes

Other outcomes

Sponsors and contacts

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