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

Budd-Chiari Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02201485
• Other study ID #: 2BCS-rencanalization
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: April 2019

Study information

• Verified date: April 2019
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: April 2019
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Budd-Chiari Syndrome
• Syndrome

Intervention

Device:
• Stent

• Balloon

Locations

Country	Name	City	State
China	Xijing Hospital of Digestive Diseases	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (6)

Han G, Qi X, Zhang W, He C, Yin Z, Wang J, Xia J, Xu K, Guo W, Niu J, Wu K, Fan D. Percutaneous recanalization for Budd-Chiari syndrome: an 11-year retrospective study on patency and survival in 177 Chinese patients from a single center. Radiology. 2013 Feb;266(2):657-67. doi: 10.1148/radiol.12120856. Epub 2012 Nov 9. — View Citation

Qi X, Guo W, He C, Zhang W, Wu F, Yin Z, Bai M, Niu J, Yang Z, Fan D, Han G. Transjugular intrahepatic portosystemic shunt for Budd-Chiari syndrome: techniques, indications and results on 51 Chinese patients from a single centre. Liver Int. 2014 Sep;34(8):1164-75. doi: 10.1111/liv.12355. Epub 2013 Nov 20. — View Citation

Qi X, Han G, Guo W, Yin Z, Fan D. Education and Imaging. Hepatobiliary and pancreatic: Budd-Chiari syndrome with infra-hepatic obstruction of inferior vena cava. J Gastroenterol Hepatol. 2013 Jun;28(6):905. doi: 10.1111/jgh.12228. — View Citation

Qi X, Han G. Images in clinical medicine. Abdominal-wall varices in the Budd-Chiari syndrome. N Engl J Med. 2014 May 8;370(19):1829. doi: 10.1056/NEJMicm1308567. — View Citation

Qi X, Wu F, Fan D, Han G. Prevalence of thrombotic risk factors in Chinese Budd-Chiari syndrome patients: results of a prospective validation study. Eur J Gastroenterol Hepatol. 2014 May;26(5):576-7. doi: 10.1097/MEG.0000000000000056. — View Citation

Qi X, Wu F, Ren W, He C, Yin Z, Niu J, Bai M, Yang Z, Wu K, Fan D, Han G. Thrombotic risk factors in Chinese Budd-Chiari syndrome patients. An observational study with a systematic review of the literature. Thromb Haemost. 2013 May;109(5):878-84. doi: 10.1160/TH12-10-0784. Epub 2013 Feb 28. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of reocclusion between PTA alone and in combination with stent-placement groups		2 years
Secondary	The survival between PTA alone and in combination with stent placement groups		2 years
Secondary	The incidence of procedure-related complications between PTA alone and in combination with stent placement groups		2 years
Secondary	The length of hospitalization between PTA alone and in combination with stent placement groups		2 years
Secondary	The symptom recurrence rate between PTA alone and in combination with stent placement groups		2 years