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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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12 December 2020 |
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Main ID: |
NCT03155256 |
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Date of registration:
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20/12/2016 |
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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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Treatment of Gastric Varices Using EUS Guided Techniques
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Scientific title:
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Comparative EUS Guided Techniques in Treatment of Gastric Varice: a Prospective, Ranzomized Study |
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Date of first enrolment:
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March 1, 2016 |
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Target sample size:
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59 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03155256 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
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Phase:
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N/A
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Countries of recruitment
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Ecuador
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Contacts
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Name:
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Carlos A Robles-medranda, 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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Ecuadorian Institute of Digestive Diseases |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Above 18 years old patients
- Who agree to participate in the study
- Proven GV (GOV II or IGV I) on initial standard diagnostic upper endoscopy
- Active bleeding, history of previous bleeding (secondary prophylaxis) and primary
prophylaxis
- Patient preference for EUS-guided therapy
Exclusion Criteria:
- Inability to provide informed consent for the procedure
- Concurrent hepato-renal syndrome and/or multi-organ failure
- Pregnancy
- Platelet count less than 50,000/ml or International Normalized Rate (INR) >2
- Esophageal stricture
- Splenic or Portal vein thrombosis because an increase risk of failure
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Gastric Varix
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Intervention(s)
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Procedure: EUS-guided injection of coils
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Procedure: EUS-guided injection of coils with cyanoacrylate
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Primary Outcome(s)
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Efficacy of EUS guided techniques (Coils + CYA vs Coils alone) for GFV treatment
[Time Frame: 12 month]
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Secondary Outcome(s)
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Safety of EUS guided techniques (Coils + CYA vs Coils alone) for GFV treatment
[Time Frame: 12 month]
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Secondary ID(s)
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Dec-18-2016
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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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