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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: |
NCT03358095 |
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Date of registration:
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26/11/2017 |
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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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Cancer of the Head of the Pancreas: Early Surgery or Preoperative Biliary Drainage?
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Scientific title:
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Cancer of the Head of the Pancreas: Early Surgery or Preoperative Biliary Drainage? A Prospective Study |
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Date of first enrolment:
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November 26, 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Withdrawn |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/NCT03358095 |
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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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Outi Lindström, 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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Name:
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Arto Kokkola, MD, PhD |
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Address:
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Email:
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Affiliation:
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Helsinki University Central Hospital |
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Name:
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Hanna Seppänen, 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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Name:
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Johanna Louhimo, 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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Name:
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Marianne Udd, 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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Name:
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Sini Vehviläinen, MD |
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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:
- Patients in this study must have a resectable tumor of the head of the pancreas, and
no evidence of distant metastasis or local vascular involvement. At the beginning of
the study it's not necessary to have an accurate histologic diagnosis, the tumor might
be malignant or benign. The patients also have jaundice with a total serum bilirubin
level of 40-250µmol/l, and are fit enough to be considered for an early surgery.
Exclusion Criteria:
- Patients with ongoing cholangitis, neoadjuvant treatments or previous biliary drainage
with stenting by means of ERCP or PTC (Percutaneous Transhepatic Cholangiogram) are
excluded.
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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Biliary Stasis
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Pancreatic Cancer
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Intervention(s)
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Device: Tannenbaum Fr 10 stent or WallFlex stent
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Primary Outcome(s)
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Emerged complications related to surgery or preoperative endoscopy within 120 days of surgery
[Time Frame: 120 days after surgery]
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Secondary ID(s)
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Early surgery vs PBD
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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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