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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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16 December 2017 |
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Main ID: |
NCT03133026 |
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Date of registration:
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25/04/2017 |
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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 Assessment of Occluded Biliary Stent and Role of Biliary Radiofrequency Ablation
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Scientific title:
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The Role of Cholangioscopy and Biliary Radio Frequency Ablation in the Management of Occluded Biliary Self-expanding Metal Stent. |
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Date of first enrolment:
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June 2016 |
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Target sample size:
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4 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03133026 |
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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: Diagnostic. 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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India
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Contacts
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Name:
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Mohan Ramchandani, MD DM |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Mohan Ramchandani, MD DM |
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Address:
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Telephone:
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9701335444 |
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Email:
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ramchandanimohan@gmail.com |
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Affiliation:
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Name:
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Mohan Ramchandani, MD DM |
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Address:
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Telephone:
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Email:
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Affiliation:
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Asian Institute of Gastroenterology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 1. Age 18 or older 2. Willing and able to comply with the study procedures and provide
written informed consent to participate in the study 3. Recurrent biliary obstructive
symptoms after biliary SEMS placement 4. Biliary SEMS occlusion.
Exclusion Criteria:
- 1. Contraindications for endoscopic techniques 2. Ongoing cholangitis. NOTE: In case a
patient presents who meets the inclusion and exclusion criteria, but has cholangitis,
then a naso-biliary drain (NBD) will be placed before the ERCP until the cholangitis
resolves.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Obstructive Jaundice
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Cholangitis
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Intervention(s)
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Device: Single operator cholangioscopy, Endoscopic biliary RFA
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Primary Outcome(s)
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Successful restoration of bile duct drainage
[Time Frame: 1 month]
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Secondary Outcome(s)
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Resolution of cholangitis
[Time Frame: 1 week and 1 month]
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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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