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Main
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Note: This record shows only 22 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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25 April 2016 |
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Main ID: |
NCT02740166 |
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Date of registration:
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12/04/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Preventing Recurrent Bleeding After Eradication of Esophageal Varices
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Scientific title:
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Banding Ligation Plus Propranolol Versus Banding Ligation to Prevent Rebleeding of Esophageal Varices |
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Date of first enrolment:
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June 2013 |
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Target sample size:
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212 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02740166 |
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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: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Wen-Chi Chen, MD |
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Address:
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Telephone:
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+886-7-3422121 |
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Email:
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wcchen@vghks.gov.tw |
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Affiliation:
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Name:
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Wen-Chi Chen, 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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Kaohsiung Veterans General Hospital. |
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Name:
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Wen-Chi Chen, MD |
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Address:
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Telephone:
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886-7-3422121 |
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Email:
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wcchen@vghks.gov.tw |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age of 20 to 80 years
- Cirrhotic patients with acute or recent esophageal variceal bleeding proven by an
endoscopy
- Stable hemodynamic condition for at least 3 days after banding ligation
Exclusion Criteria:
- Hepatocellular carcinoma or other malignancy
- Stroke or active sepsis
- Chronic kidney disease under renal replacement therapy
- Contraindications to non-selective beta-blockers
- A history of non-selective beta-blockers use, sclerotherapy, banding ligation,
transjugular intrahepatic porto-systemic shunt, or shunt surgery
- Serum total bilirubin >10 mg/dL
- Grade III/IV hepatic encephalopathy
- Refractory ascites
- Hepato-renal syndrome
- Pregnancy
- Severe heart failure (NYHA Fc III/IV)
- Bronchial asthma or chronic obstructive pulmonary disease
- Second or third degree atrioventricular block
- Sick sinus syndrome
- Pacemaker use
- Severe hypotension
- Refusal to participate
Age minimum:
20 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Esophageal Varices
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Intervention(s)
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Drug: propranolol
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Primary Outcome(s)
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mortality or liver transplantation
[Time Frame: 6 years]
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recurrent esophageal variceal bleeding
[Time Frame: 6 years]
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Secondary Outcome(s)
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adverse effects
[Time Frame: 6 years]
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Secondary ID(s)
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VGHKS13-CT6-06
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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