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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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9 January 2017 |
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Main ID: |
NCT02794987 |
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Date of registration:
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01/05/2016 |
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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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Cholangioscopic Classification of Bile Duct Lesions
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Scientific title:
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Proposal of a Macroscopic Classification for Tissular Lesions of the Bile Duct Detected During Per Oral Cholangioscopy (POCS) |
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Date of first enrolment:
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December 2015 |
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Target sample size:
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130 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02794987 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Crossover, Time Perspective: Prospective
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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
- Patients with tissular biliary lesions detected by POCS
Exclusion Criteria:
- Tissular lesions with no histology confirmation (either biopsy or surgical resection
in case of malignancy suspicion) or 6 months follow-up by POCS (in case of benign
suspicion)
- Severe uncontrolled coagulopathy
- Esophageal, gastric or duodenal stenosing tumors with no possibility of scope passage
- Prior history of esophageal, gastric or surgery with no possibility of scope passage
- Contrast allergy
- Pregnancy and lactation
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bile Duct Lesions
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Intervention(s)
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Device: SpyGlass® choledoscopy
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Primary Outcome(s)
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The accuracy, sensitivity, specificity, positive and negative predictive value of the macroscopic classification will be measure in order to perform a prospective validation of the classification.
[Time Frame: 12 month]
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Evaluation of vascular and surface features of benign and malignant lesions detected by POCS images, that could be used to perform a macroscopic classification of bile duct tissular lesions
[Time Frame: 24 month]
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Secondary ID(s)
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MAY-1-2016
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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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