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

Study Overview
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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.

Official Title
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Balloon Angioplasty Alone Versus in Combination With Stent Placement for the Treatment of Budd-Chiari Syndrome in China: An Randomized Controlled Trial

Conditions
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Budd-Chiari Syndrome

Intervention / Treatment
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* Device: Stent
* Device: Balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent. Age 18-75 years old. Budd-Chiari syndrome Child-Pugh score <13 points. Eligible for percutaneous recanalization. Exclusion Criteria: Pregnancy or lactation. Malignancy. HIV infection. Severe cardiac or lung diseases. Severe renal dysfunction (serum> 265.2 umol/l). Uncontrolled systemic infection. Allergic to contrast agents. Poor compliance. A prior history of percutaneous recanalization. Ineligible for percutaneous recanalization. Liver cirrhosis with severe portal hypertension-related complications. Acute liver failure. Progressive deterioration of liver function.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PTA in combination with stent-placement<br>In this group, the patients will undergo percutaneous balloon angioplasty with or without stent-placement angioplasty in combination with stent-placement. | Device: Stent<br> <br> Device: Balloon<br> <br> |
| Active Comparator: PTA alone<br>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. | Device: Balloon<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of reocclusion between PTA alone and in combination with stent-placement groups |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The survival between PTA alone and in combination with stent placement groups |  | 2 years | 
| The incidence of procedure-related complications between PTA alone and in combination with stent placement groups |  | 2 years | 
| The length of hospitalization between PTA alone and in combination with stent placement groups |  | 2 years | 
| The symptom recurrence rate between PTA alone and in combination with stent placement groups |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Budd-Chiari syndrome, percutaneous recanalization, treatment, reocclusion, patency