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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02201485

Enrollment

Registered

2014-07-28

Start date

2014-05-31

Completion date

2019-04-30

Last updated

2019-04-23

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

Conditions

Budd-Chiari Syndrome

Keywords

Budd-Chiari syndrome, percutaneous recanalization, treatment, reocclusion, patency

Brief summary

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.

Interventions

DEVICEStent

DEVICEBalloon

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
The incidence of reocclusion between PTA alone and in combination with stent-placement groups	2 years

Secondary

Measure	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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026