Clinical trial NCT02201485: Budd-Chiari Syndrome in China: Balloon Angioplasty Alone or Combined With Stent Placement?
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Budd-Chiari Syndrome
Keywords: Budd-Chiari syndrome
percutaneous recanalization
treatment
reocclusion
patency
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2014-07-28
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: The incidence of reocclusion between PTA alone and in combination with stent-placement groups
timeFrame: 2 years
Secondary outcomes:
measure: The survival between PTA alone and in combination with stent placement groups
timeFrame: 2 years
measure: The incidence of procedure-related complications between PTA alone and in combination with stent placement groups
timeFrame: 2 years
measure: The length of hospitalization between PTA alone and in combination with stent placement groups
timeFrame: 2 years
measure: The symptom recurrence rate between PTA alone and in combination with stent placement groups
timeFrame: 2 years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases
state: Shanxi
Study officials:
affiliation: Xijing Hospital of Digestive Diseases, Fourth Military Medical University
name: Guohong Han, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. No abstract available.
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.
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. No abstract available.
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.
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. No abstract available.
citation: Wang Q, Li K, He C, Yuan X, Luo B, Qi X, Guo W, Bai W, Yu T, Fan J, Wang Z, Yuan J, Li X, Zhu Y, Han N, Niu J, Lv Y, Liu L, Li J, Tang S, Guo S, Wang E, Xia D, Wang Z, Cai H, Wang J, Yin Z, Xia J, Fan D, Han G. Angioplasty with versus without routine stent placement for Budd-Chiari syndrome: a randomised controlled trial. Lancet Gastroenterol Hepatol. 2019 Sep;4(9):686-697. doi: 10.1016/S2468-1253(19)30177-3. Epub 2019 Jul 3.