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NCT Number: NCT02201485

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

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.

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Key information

Conditions

Budd-Chiari Syndrome Cardiovascular Diseases Digestive System Diseases Embolism and Thrombosis Liver Diseases Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospital of Digestive Diseases

Xi’an, Shanxi, 710032, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

stent

Device

balloon

Device

Primary outcomes

  1. The incidence of reocclusion between PTA alone and in combination with stent-placement groups

    Time frame: 2 years

Secondary outcomes

  1. The survival between PTA alone and in combination with stent placement groups

    Time frame: 2 years

  2. The incidence of procedure-related complications between PTA alone and in combination with stent placement groups

    Time frame: 2 years

  3. The length of hospitalization between PTA alone and in combination with stent placement groups

    Time frame: 2 years

  4. The symptom recurrence rate between PTA alone and in combination with stent placement groups

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2019
First posted
Jul 28, 2014
Registry last updated
Apr 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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