Budd-Chiari Syndrome in China: Balloon Angioplasty Alone or Combined With Stent Placement?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2019-04-30

Brief Summary

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Budd-Chiari syndrome (BCS) is defined as the hepatic outflow obstruction from the small hepatic veins to the confluence between inferior vena cava and right atrium, which often leads to the life-threatening complications, such as liver failure and portal hypertension-related complications. At present, a stepwise treatment strategy is employed, including anticoagulation, thrombolysis, percutaneous recanalization (i.e., percutaneous transluminal angioplasty \[PTA\] alone or in combination with stent placement), transjugular intrahepatic portosystemic shunt, and liver transplantation. In West, only less than 20% of BCS patients underwent percutaneous recanalization; by contrast, percutaneous recanalization is the most common treatment modality used in China.

Recently, an 11-year retrospective case series of 177 Chinese patients with primary BCS has shown a higher rate of re-occlusion in the PTA alone group than in the PTA combined with stent placement group (31% versus 7.7%, p\<0.001). In addition, re-occlusion was regarded as the independent predictor of mortality. Accordingly, we hypothesized that PTA alone might have a worse survival than PTA combined with stent placement in Chinese patients with primary BCS.

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Detailed Description

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Conditions

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Budd-Chiari Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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PTA in combination with stent-placement

In this group, the patients will undergo percutaneous balloon angioplasty with or without stent-placement angioplasty in combination with stent-placement.

Group Type ACTIVE_COMPARATOR

Stent

Intervention Type DEVICE

Balloon

Intervention Type DEVICE

PTA alone

In this group, the patients will undergo percutaneous balloon angioplasty alone. The patients will transfer to the stent placement in the following cases: 1) reocclusion with thrombosis; and 2) at least 2 reocclusion events.

Group Type ACTIVE_COMPARATOR

Balloon

Intervention Type DEVICE

Interventions

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Stent

Intervention Type DEVICE

Balloon

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Informed consent.
2. Age 18-75 years old.
3. Budd-Chiari syndrome
4. Child-Pugh score \<13 points.
5. Eligible for percutaneous recanalization.

Exclusion Criteria

1. Pregnancy or lactation.
2. Malignancy.
3. HIV infection.
4. Severe cardiac or lung diseases.
5. Severe renal dysfunction (serum\> 265.2 umol/l).
6. Uncontrolled systemic infection.
7. Allergic to contrast agents.
8. Poor compliance.
9. A prior history of percutaneous recanalization.
10. Ineligible for percutaneous recanalization.
11. Liver cirrhosis with severe portal hypertension-related complications.
12. Acute liver failure.
13. Progressive deterioration of liver function.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes