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

Air Force Military Medical University of People's Liberation Army

Status: Completed

Conditions: Budd-Chiari Syndrome

Treatments: Device: Stent; Device: Balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT02201485

2BCS-rencanalization

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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88 participants in 2 patient groups

PTA in combination with stent-placement

Active Comparator group

Description:

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

Treatment:

Device: Balloon

Device: Stent

PTA alone

Active Comparator group

Description:

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.

Treatment:

Device: Balloon