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

NCT06960473 | Not Yet Recruiting

• 1 other identifier: XYFY2024-JS004-01
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Budd-Chiari Syndrome

Outcome Measures

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

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

Study Arms (2)

IVUS Group

EXPERIMENTAL

Patients receiving intervention guided by Intravascular Ultrasound (IVUS).

Device: Intravascular Ultrasound

DSA Group

ACTIVE COMPARATOR

Patients receiving intervention guided by Digital Subtraction Angiography (DSA).

Device: Digital Subtraction Angiography

Interventions

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.

IVUS Group

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.

DSA Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University: lead

Study Sites (1)

Department of Interventional Radiology, the Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

Location

MeSH Terms

Conditions

Budd-Chiari Syndrome

Interventions

Ultrasonography, Interventional; Angiography, Digital Subtraction

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Radiographic Image Enhancement; Image Enhancement; Photography; Angiography; Radiography; Subtraction Technique; Diagnostic Techniques, Cardiovascular

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 7, 2025
• Study Start: May 18, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 7, 2025

Record last verified: 2025-04

Locations

CN (1)