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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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7 June 2021 |
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Main ID: |
NCT03350763 |
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Date of registration:
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18/11/2017 |
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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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Biliary Drainage Preceding Possible Pancreaticoduodenectomy. Are Self-expandable Metallic Stents (SEMS) Superior to Plastic Stents?
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Scientific title:
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Biliary Drainage Preceding Possible Pancreaticoduodenectomy. Are Self-expandable Metallic Stents (SEMS) Superior to Plastic Stents? |
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Date of first enrolment:
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November 18, 2017 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT03350763 |
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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: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Finland
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Contacts
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Name:
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Leena Kylänpää, 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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Helsinki University Central Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Resectable tumor of the head of the pancreas
- Elevated serum bilirubin levels
- Radiologically visible dilatation of the biliary system
Exclusion Criteria:
- Distant metastasis
- Inoperable tumor or other reason, why the patient is unfit for surgery
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pancreatic Cancer
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Intervention(s)
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Device: Tannenbaum 10 Fr biliary stent
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Device: Self-expandable metallic biliary stent
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Primary Outcome(s)
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Stent failure rate, and need for re-procedure before pancreaticoduodenectomy.
[Time Frame: Evaluation at the day of pancreatic surgery]
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Secondary Outcome(s)
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Other complications related to preoperative biliary decompression, and post-surgical complications
[Time Frame: Complication emerged within 120 days from pancreaticoduodenectomy]
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Secondary ID(s)
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HUS/2470/2017
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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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