Budd-Chiari Syndrome in China: Balloon Angioplasty Alone or Combined With Stent Placement?
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|ClinicalTrials.gov Identifier: NCT02201485|
Recruitment Status : Completed
First Posted : July 28, 2014
Last Update Posted : April 23, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Budd-Chiari Syndrome||Device: Stent Device: Balloon||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||Balloon Angioplasty Alone Versus in Combination With Stent Placement for the Treatment of Budd-Chiari Syndrome in China: An Randomized Controlled Trial|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||April 2019|
Active Comparator: 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.
Active Comparator: 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.
- The incidence of reocclusion between PTA alone and in combination with stent-placement groups [ Time Frame: 2 years ]
- The survival between PTA alone and in combination with stent placement groups [ Time Frame: 2 years ]
- The incidence of procedure-related complications between PTA alone and in combination with stent placement groups [ Time Frame: 2 years ]
- The length of hospitalization between PTA alone and in combination with stent placement groups [ Time Frame: 2 years ]
- The symptom recurrence rate between PTA alone and in combination with stent placement groups [ Time Frame: 2 years ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02201485
|Xijing Hospital of Digestive Diseases|
|Xi'an, Shanxi, China, 710032|
|Principal Investigator:||Guohong Han, MD||Xijing Hospital of Digestive Diseases, Fourth Military Medical University|