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Multicenter clinical study of drug coated balloon in the treatment of hepatic vein stenosis and obstruction

A multicenter randomized controlled trial of drug coated balloon versus conventional balloon in the treatment of hepatic vein stenosis and occlusion

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050395
Enrollment
Unknown
Registered
2021-08-27
Start date
2021-10-01
Completion date
Unknown
Last updated
2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Budd chiari syndrome with hepatic vein stenosis and obstruction

Interventions

Group A:Conventional balloon
Group B:Drug coated balloon

Sponsors

The First Medical Center of PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
14 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 14 years and <= 60 years; 2. The clinical, laboratory and imaging data were complete. Three main hepatic veins were definitely diagnosed as stenosis or occlusion, but at least one hepatic vein was short segment stenosis or occlusion (the stenosis or occlusion segment was less than 4 cm); 3. ECOG-PS score was 0-1; 4. There were no other contraindications of angiography (such as contrast agent allergy, uncontrolled infection, uncorrectable coagulation dysfunction, etc.); 5. The subjects volunteered to participate in the study, signed informed consent, and were able to cooperate with the follow-up and complete the research project.

Exclusion criteria

Exclusion criteria: 1. Severe liver dysfunction (ALT/AST >= 4 ULN, DBIL >= 3 ULN); 2. Extensive hepatic vein stenosis or occlusion; 3. Active stage of infectious disease; 4. Patients with severe heart, lung, kidney, brain and other basic diseases can not tolerate interventional therapy.

Design outcomes

Primary

MeasureTime frame
Patency rate of hepatic vein;Survival rate;

Countries

China

Contacts

Public ContactWang Maoqiang

The First Medical Center of PLA General Hospital

wangmq@vip.sina.com+86 13910531926

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026