Budd-Chiari SyndromeNCT02201485
Budd-Chiari Syndrome in China: Balloon Angioplasty Alone or Combined With Stent Placement?
A study testing Stent and Balloon in people with Budd-Chiari Syndrome, run by Air Force Military Medical University, China at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Budd-Chiari Syndrome
- What is being tested?
- Stent and Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- May 2014to Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent.
- Age 18-75 years old.
- Budd-Chiari syndrome
- Child-Pugh score <13 points.
- Eligible for percutaneous recanalization.
Who cannot join
- Pregnancy or lactation.
- Malignancy.
- HIV infection.
- Severe cardiac or lung diseases.
- Severe renal dysfunction (serum> 265.2 umol/l).
- Uncontrolled systemic infection.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Budd-Chiari Syndrome
- Being tested
- Stent, Balloon
- Keywords
- Budd-Chiari syndrome, percutaneous recanalization, treatment, reocclusion, patency
- Medical subject headings
- Budd-Chiari Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StentDevice
BalloonDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of reocclusion between PTA alone and in combination with stent-placement groups
Measured: 2 years
Secondary outcomes (4)
The survival between PTA alone and in combination with stent placement groups
Measured: 2 years
The incidence of procedure-related complications between PTA alone and in combination with stent placement groups
Measured: 2 years
The length of hospitalization between PTA alone and in combination with stent placement groups
Measured: 2 years
The symptom recurrence rate between PTA alone and in combination with stent placement groups
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study startMay 2014
- Primary completionSep 2017
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Budd-Chiari SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guohong Han, Air Force Military Medical University, China
- Investigators
- Guohong Han, MD, Principal investigator, Xijing Hospital of Digestive Diseases, Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201485
- Sponsor's protocol ID
- 2BCS-rencanalization
- Status last verified
- Apr 2019
- First submitted
- 24 Jul 2014
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23143028Qi 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.
PubMed 24806162Qi 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.
PubMed 23447059Qi 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.
PubMed 24694738Qi 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.
PubMed 24256572Qi 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.
PubMed 23692579Wang 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.
PubMed 31279647
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balloon Angioplasty Alone Versus in Combination With Stent Placement for the Treatment of Budd-Chiari Syndrome in China: An Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02201485
- Acronym / sponsor ID
- 2BCS-rencanalization
- Conditions
- Budd-Chiari Syndrome
- Keywords
- Budd-Chiari syndrome, percutaneous recanalization, treatment, reocclusion, patency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Sep 2017 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 28 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTA in combination with stent-placement | Active comparator | Device: Stent, Device: BalloonIn this group, the patients will undergo percutaneous balloon angioplasty with or without stent-placement angioplasty in combination with stent-placement. |
| PTA alone | Active comparator | Device: BalloonIn 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent.
- Age 18-75 years old.
- Budd-Chiari syndrome
- Child-Pugh score <13 points.
- Eligible for percutaneous recanalization.
Key exclusion criteria (13 listed)
- Pregnancy or lactation.
- Malignancy.
- HIV infection.
- Severe cardiac or lung diseases.
- Severe renal dysfunction (serum> 265.2 umol/l).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stent | Device | PTA in combination with stent-placement |
| Balloon | Device | PTA alone, PTA in combination with stent-placement |
Primary outcome
The incidence of reocclusion between PTA alone and in combination with stent-placement groups
Time frame: 2 years
4 secondary outcomes
The survival between PTA alone and in combination with stent placement groups
Time frame: 2 years
The incidence of procedure-related complications between PTA alone and in combination with stent placement groups
Time frame: 2 years
The length of hospitalization between PTA alone and in combination with stent placement groups
Time frame: 2 years
The symptom recurrence rate between PTA alone and in combination with stent placement groups
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Background: PubMed 23143028Han 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.
- Background: PubMed 24806162Qi 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.
- Background: PubMed 23447059Qi 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.
- Background: PubMed 24694738Qi 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.
- Background: PubMed 24256572Qi 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.
- Background: PubMed 23692579Qi 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.
- Derived from this study: PubMed 31279647Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guohong Han, MD principal investigator
Xijing Hospital of Digestive Diseases, Fourth Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stent and Balloon in people with Budd-Chiari Syndrome, run by Air Force Military Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of reocclusion between PTA alone and in combination with stent-placement groups (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02201485, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2019.