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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTA in combination with stent-placement | Active Comparator | In this group, the patients will undergo percutaneous balloon angioplasty with or without stent-placement angioplasty in combination with stent-placement. |
|
| PTA alone | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stent | Device |
| ||
| Balloon |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of reocclusion between PTA alone and in combination with stent-placement groups | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| The survival between PTA alone and in combination with stent placement groups | 2 years | |
| The incidence of procedure-related complications between PTA alone and in combination with stent placement groups | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guohong Han, MD | Xijing Hospital of Digestive Diseases, Fourth Military Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital of Digestive Diseases | Xi’an | Shanxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23143028 | Background | 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. | |
| 24806162 |
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| ID | Term |
|---|---|
| D006502 | Budd-Chiari Syndrome |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
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| ID | Term |
|---|---|
| D015607 | Stents |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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|
| The length of hospitalization between PTA alone and in combination with stent placement groups | 2 years |
| The symptom recurrence rate between PTA alone and in combination with stent placement groups | 2 years |
| 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. |
| 23447059 | Background | 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. |
| 24694738 | Background | 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. |
| 24256572 | Background | 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. |
| 23692579 | Background | 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. |
| 31279647 | Derived | 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. |
| D016769 |
| Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |