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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: Fourth Military Medical University

Current Primary Outcome: The incidence of reocclusion between PTA alone and in combination with stent-placement groups [ Time Frame: 2 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 cost between PTA alone and in combination with stent placement groups [ Time Frame: 2 years ]


Original Secondary Outcome: Same as current

Information By: Fourth Military Medical University

Dates:
Date Received: July 24, 2014
Date Started: May 2014
Date Completion: November 2016
Last Updated: June 27, 2016
Last Verified: June 2016