TIPS With 8- OR 10-mm Covered Stent for Preventing Variceal Rebleeding (T8/10SVB)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01410591|
Recruitment Status : Completed
First Posted : August 5, 2011
Last Update Posted : January 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Decompensated Cirrhosis Portal Hypertension Bleeding Varices||Device: 8-mm covered stent group Device: 10-mm covered stent group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||127 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of TIPS With 8- or 10-mm Covered Stent for Preventing Variceal Rebleeding in Cirrhotic Patients.|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Active Comparator: 10-mm covered stent group
Patients treated with 10-mm covered stent.
Device: 10-mm covered stent group
Creating a shunt between hepatic vein and portal vein with a 10-mm covered stent by TIPS procedure.
Active Comparator: 8-mm covered stent group
Patients treated with 8-mm covered stent.
Device: 8-mm covered stent group
Creating a shunt between hepatic vein and portal vein with a 8-mm covered stent by TIPS procedure.
- Incidence of shunt dysfunction. [ Time Frame: 2 years ]
- Incidence of variceal rebleeding [ Time Frame: 2 years ]
- Incidence of hepatic encephalopathy [ Time Frame: 2 years ]
- Survival [ Time Frame: 2 years ]
- Incidence of hepatic myelopathy [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01410591
|Xijing Hospital of Digestive Diseases, Fourth Military Medical University|
|Xi`an, Shaanxi, China, 710032|
|Principal Investigator:||Guohong Han, PhD & MD||Xijing Hospital of Digestive Diseases, Fourth Military Medical University|