- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01410591
TIPS With 8- OR 10-mm Covered Stent for Preventing Variceal Rebleeding (T8/10SVB)
January 23, 2016 updated by: Guohong Han, Air Force Military Medical University, China
The Effect of TIPS With 8- or 10-mm Covered Stent for Preventing Variceal Rebleeding in Cirrhotic Patients.
The purpose of this study is to determine whether transjugular intrahepatic portosystemic shunt (TIPS) with 10-mm covered stent is associated with lower shunt dysfunction in comparing TIPS with 8-mm covered stent in cirrhotic patients with at least one episode of variceal bleeding.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
127
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710032
- Xijing Hospital of Digestive Diseases, Fourth Military Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Cirrhotic patients with at least one episode of variceal bleeding
- No active bleeding within 5 days before TIPS
- Child-Pugh score ≤13
- Signed written informed consent
Exclusion Criteria:
- An age <18 years or >75 years
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 10-mm covered stent group
Patients treated with 10-mm covered stent.
|
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.
|
Creating a shunt between hepatic vein and portal vein with a 8-mm covered stent by TIPS procedure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of shunt dysfunction.
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Survival
Time Frame: 2 years
|
2 years
|
Incidence of variceal rebleeding
Time Frame: 2 years
|
2 years
|
Incidence of hepatic encephalopathy
Time Frame: 2 years
|
2 years
|
Incidence of hepatic myelopathy
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Guohong Han, PhD & MD, Xijing Hospital of Digestive Diseases, Fourth Military Medical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
August 4, 2011
First Submitted That Met QC Criteria
August 4, 2011
First Posted (Estimate)
August 5, 2011
Study Record Updates
Last Update Posted (Estimate)
January 26, 2016
Last Update Submitted That Met QC Criteria
January 23, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- T8/10CSVB
- FMMU-XHDD 003 (Registry Identifier: Fourth Military Medical University)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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