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

NCT02201485 | Completed

• 1 other identifier: 2BCS-rencanalization
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Budd-Chiari Syndrome

Keywords

Budd-Chiari syndrome; percutaneous recanalization; treatment; reocclusion; patency

Outcome Measures

Primary Outcomes (1)

• The incidence of reocclusion between PTA alone and in combination with stent-placement groups

  2 years

Secondary Outcomes (4)

• 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

• 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

Study Arms (2)

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.

Device: Stent; Device: Balloon

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.

Device: Balloon

Interventions

Stent DEVICE

PTA in combination with stent-placement

Balloon DEVICE

PTA alone; PTA in combination with stent-placement

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent.
• Age 18-75 years old.
• Budd-Chiari syndrome
• Child-Pugh score \<13 points.
• Eligible for percutaneous recanalization.

You may not qualify if:

• Pregnancy or lactation.
• Malignancy.
• HIV infection.
• Severe cardiac or lung diseases.
• Severe renal dysfunction (serum\> 265.2 umol/l).
• Uncontrolled systemic infection.
• Allergic to contrast agents.
• Poor compliance.
• A prior history of percutaneous recanalization.
• Ineligible for percutaneous recanalization.
• Liver cirrhosis with severe portal hypertension-related complications.
• Acute liver failure.
• Progressive deterioration of liver function.

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Xijing Hospital of Digestive Diseases

Xi’an, Shanxi, 710032, China

Location

Related Publications (7)

• 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.

  PMID: 23143028 BACKGROUND

• 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.

  PMID: 24806162 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.

  PMID: 23447059 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.

  PMID: 24694738 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.

  PMID: 24256572 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.

  PMID: 23692579 BACKGROUND

• 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.

  PMID: 31279647 DERIVED

MeSH Terms

Conditions

Budd-Chiari Syndrome

Interventions

Stents

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Guohong Han, MD

  Xijing Hospital of Digestive Diseases, Fourth Military Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: July 28, 2014
• Study Start: May 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: April 1, 2019
• Last Updated: April 23, 2019

Record last verified: 2019-04

Locations

CN (1)