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

April 20, 2019 updated by: Guohong Han, Air Force Military Medical University, China

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanxi
      • Xi'an, Shanxi, China, 710032
        • Xijing Hospital of Digestive Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
The survival between PTA alone and in combination with stent placement groups
Time Frame: 2 years
2 years
The incidence of procedure-related complications between PTA alone and in combination with stent placement groups
Time Frame: 2 years
2 years
The length of hospitalization between PTA alone and in combination with stent placement groups
Time Frame: 2 years
2 years
The symptom recurrence rate between PTA alone and in combination with stent placement groups
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Air Force Military Medical University, China

Investigators

  • Principal Investigator: Guohong Han, MD, Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

July 24, 2014

First Submitted That Met QC Criteria

July 25, 2014

First Posted (Estimate)

July 28, 2014

Study Record Updates

Last Update Posted (Actual)

April 23, 2019

Last Update Submitted That Met QC Criteria

April 20, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2BCS-rencanalization

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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