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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: |
NCT00679952 |
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Date of registration:
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15/05/2008 |
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Primary sponsor: |
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Public title:
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Closed Suction Drainage and Natural Drainage of the Pancreatic Duct in Pancreaticojejunostomy
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Scientific title:
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Randomised Prospective Study of Clinical Outcomes After Closed Suction Drainage and Natural Drainage of the Pancreatic Duct in Pancreaticojejunostomy After Pancreatoduodenectomy |
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Date of first enrolment:
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March 2007 |
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Target sample size:
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168 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00679952 |
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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: Prevention
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Sun-Whe Kim, MD., PhD. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Seoul National University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All patients who undergo duct-to-mucosa pancreaticojejunostomy reconstruction after pancreatoduodenectomy in our institution
Exclusion criteria:
- less than 15 years old, or older than 85 years old
Age minimum:
15 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pancreatic Fistula
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Intervention(s)
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Procedure: closed suction drainage of pancreatic duct
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Procedure: natural drainage of pancreatic duct
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Primary Outcome(s)
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Number of Patients With Pancreatic Fistula
[Time Frame: postoperative 1 week]
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Secondary Outcome(s)
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Severity of Pancreatic Fistulas
[Time Frame: 2 years]
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Secondary ID(s)
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H-0612-018-191
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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