TIPS With 8- OR 10-mm Covered Stent for Preventing Variceal Rebleeding
NCT ID: NCT01410591
Last Updated: 2016-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
127 participants
INTERVENTIONAL
2012-07-31
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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10-mm covered stent group
Patients treated with 10-mm covered stent.
10-mm covered stent group
Creating a shunt between hepatic vein and portal vein with a 10-mm covered stent by TIPS procedure.
8-mm covered stent group
Patients treated with 8-mm covered stent.
8-mm covered stent group
Creating a shunt between hepatic vein and portal vein with a 8-mm covered stent by TIPS procedure.
Interventions
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8-mm covered stent group
Creating a shunt between hepatic vein and portal vein with a 8-mm covered stent by TIPS procedure.
10-mm covered stent group
Creating a shunt between hepatic vein and portal vein with a 10-mm covered stent by TIPS procedure.
Eligibility Criteria
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Inclusion Criteria
* No active bleeding within 5 days before TIPS
* Child-Pugh score ≤13
* Signed written informed consent
Exclusion Criteria
* With TIPS contraindications
* Past or present history of hepatic encephalopathy
* Pregnancy or breast-feeding
* Hepatic carcinoma and/or other malignancy diseases
* Sepsis
* Spontaneous bacterial peritonitis
* Uncontrollable hypertension
* Serious cardiac or pulmonary dysfunction
* Renal failure
* Portal vein thrombosis
* History of organ transplantation
* History of HIV (human immunodeficiency viruses) infection
18 Years
75 Years
ALL
No
Sponsors
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Air Force Military Medical University, China
OTHER
Responsible Party
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Guohong Han
Head of Department of Digestive Interventional Radiology
Principal Investigators
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Guohong Han, PhD & MD
Role: PRINCIPAL_INVESTIGATOR
Xijing Hospital of Digestive Diseases, Fourth Military Medical University
Locations
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Xijing Hospital of Digestive Diseases, Fourth Military Medical University
Xi'an, Shaanxi, China
Countries
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References
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Riggio O, Ridola L, Angeloni S, Cerini F, Pasquale C, Attili AF, Fanelli F, Merli M, Salvatori FM. Clinical efficacy of transjugular intrahepatic portosystemic shunt created with covered stents with different diameters: results of a randomized controlled trial. J Hepatol. 2010 Aug;53(2):267-72. doi: 10.1016/j.jhep.2010.02.033. Epub 2010 Apr 27.
Wang Q, Lv Y, Bai M, Wang Z, Liu H, He C, Niu J, Guo W, Luo B, Yin Z, Bai W, Chen H, Wang E, Xia D, Li X, Yuan J, Han N, Cai H, Li T, Xie H, Xia J, Wang J, Zhang H, Wu K, Fan D, Han G. Eight millimetre covered TIPS does not compromise shunt function but reduces hepatic encephalopathy in preventing variceal rebleeding. J Hepatol. 2017 Sep;67(3):508-516. doi: 10.1016/j.jhep.2017.05.006. Epub 2017 May 12.
Other Identifiers
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FMMU-XHDD 003
Identifier Type: REGISTRY
Identifier Source: secondary_id
T8/10CSVB
Identifier Type: -
Identifier Source: org_study_id
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