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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
Sponsor:
Information provided by (Responsible Party):
Guohong Han, Fourth Military Medical University

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.


Condition or disease Intervention/treatment Phase
Budd-Chiari Syndrome Device: Stent Device: Balloon Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
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.
Device: Stent
Device: Balloon
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.
Device: Balloon



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

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02201485


Locations
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China, Shanxi
Xijing Hospital of Digestive Diseases
Xi'an, Shanxi, China, 710032
Sponsors and Collaborators
Fourth Military Medical University
Investigators
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Principal Investigator: Guohong Han, MD Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Guohong Han, Professor, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT02201485    
Other Study ID Numbers: 2BCS-rencanalization
First Posted: July 28, 2014    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Keywords provided by Guohong Han, Fourth Military Medical University:
Budd-Chiari syndrome
percutaneous recanalization
treatment
reocclusion
patency
Additional relevant MeSH terms:
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Budd-Chiari Syndrome
Syndrome
Disease
Pathologic Processes
Liver Diseases
Digestive System Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases