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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: |
NCT02220010 |
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Date of registration:
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18/08/2014 |
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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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Does Post Operative Pancreatic Fistula, After Left Sided Resections, Heal Faster After the Introduction of a Pancreatic Stent?
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Scientific title:
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Does a Pancreatic Stent Reduce the Healing Time of Post Operative Pancreatic Fistula (POPF) After Distal Pancreatic Resection - an Open Randomized Clinical Multicenter Trial |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02220010 |
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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: Treatment
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Phase:
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N/A
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Countries of recruitment
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Sweden
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Contacts
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Name:
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John Blomberg, MD, PhD |
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Address:
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Telephone:
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+46(0)703983060 |
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Email:
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john.blomberg@karolinska.se |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Signed informed consent
- Left sided or distal pancreatic resection
- Grade B or C fistula on postoperative day 3 or later
Exclusion Criteria:
- Do not want to participate in study
- Can not read patient information in swedish
- The papilla can not be endoscopically reached
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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Healing Time of Post Operative Pancreatic Fistulas
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Intervention(s)
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Device: Pancreatic stent
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Primary Outcome(s)
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POPF healing time (days)
[Time Frame: 12 days (median hospital stay)]
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Secondary Outcome(s)
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POPF grade (A,B,C)
[Time Frame: 12 days (median hospital stay)]
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Secondary ID(s)
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POPF and stenting-002
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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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