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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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19 February 2015 |
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Main ID: |
NCT01068886 |
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Date of registration:
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14/09/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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External Pancreatic Duct Stent After Pancreaticoduodenectomy
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Scientific title:
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External Pancreatic Duct Stent After Pancreaticoduodenectomy: a Prospective Randomized Multicenter Trial |
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Date of first enrolment:
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January 2006 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01068886 |
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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, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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arnaud - jean-pierre, professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria:
- All patients scheduled for elective PD,
- Confirmation of the soft pancreas or nondilated pancreatic duct during PD.
Exclusion criteria:
- Age less than 18 year,
- Emergency surgery,
- Previous pancreatic surgery,
- Previous susmesocolic radiotherapy.
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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Pancreatic Fistula
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Intervention(s)
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Procedure: External pancreatic stent
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Primary Outcome(s)
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pancreatic fistula
[Time Frame: on postoperative day 30]
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Secondary Outcome(s)
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overall morbidity
[Time Frame: postoperative day 30]
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Secondary ID(s)
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PHRC 04-04
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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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