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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01410591 |
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Date of registration:
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04/08/2011 |
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Primary sponsor: |
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Public title:
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TIPS With 8- OR 10-mm Covered Stent for Preventing Variceal Rebleeding
T8/10SVB |
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Scientific title:
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The Effect of TIPS With 8- or 10-mm Covered Stent for Preventing Variceal Rebleeding in Cirrhotic Patients. |
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Date of first enrolment:
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July 2012 |
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Target sample size:
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120 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01410591 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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China
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Contacts
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Name:
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Guohong Han, MD |
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Address:
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Telephone:
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86-29-84771528 |
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Email:
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hangh@fmmu.edu.cn |
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Affiliation:
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Name:
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Ming Bai, MD |
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Address:
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Telephone:
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86-29-84771528 |
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Email:
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ccckycdgd@yahoo.com.cn |
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Affiliation:
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Name:
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Guohong Han, PhD & MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Xijing Hospital of Digestive Diseases, Fourth Military Medical University |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bleeding Varices
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Decompensated Cirrhosis
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Portal Hypertension
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Intervention(s)
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Device: 10-mm covered stent group
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Device: 8-mm covered stent group
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Primary Outcome(s)
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Incidence of shunt dysfunction.
[Time Frame: 2 years]
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Secondary Outcome(s)
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Incidence of hepatic encephalopathy
[Time Frame: 2 year]
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Incidence of hepatic myelopathy
[Time Frame: 2 year]
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Incidence of variceal rebleeding
[Time Frame: 2 years]
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Survival
[Time Frame: 2 year]
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Secondary ID(s)
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FMMU-XHDD 003
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T8/10CSVB
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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