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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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9 March 2015 |
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Main ID: |
NCT02376907 |
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Date of registration:
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19/02/2015 |
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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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Biliary Drainage in Patients With Duodenal Metal Stent
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Scientific title:
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Multinational Study on Endoscopic Management of Distal Malignant Biliary Obstruction Combined With Gastric Outlet Obstruction |
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Date of first enrolment:
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January 2010 |
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Target sample size:
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200 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02376907 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Retrospective
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Phase:
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N/A
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Countries of recruitment
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China
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Hong Kong
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India
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Japan
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Korea, Republic of
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Malaysia
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Singapore
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Taiwan
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Thailand
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Contacts
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Name:
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Hiroyuki Isayama, 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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Graduate School of Medicine, The University of Tokyo |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients who underwent endoscopic placement of a duodenal SEMS for nonresectable
malignant GOO.
- Patients who underwent endoscopic biliary drainage for nonresectable MBO.
- MBO was located = 2 cm from the bifurcation.
- Patients who could be followed up more than three months after completion of both
biliary drainage and duodenal SEMS placement.
- Age =20 years.
- Irrespective of sex and a primary disease.
Exclusion Criteria:
- Patients who underwent surgical bypass for GOO.
- Patients who underwent percutaneous and surgical biliary drainage prior to the
placement of duodenal SEMS.
- Patients with altered gastrointestinal anatomy (Billroth-II reconstruction, Roux-en-Y
reconstruction, etc.).
- Patients who would not give a consent to the report of their own data.
- Patients considered ineligible for inclusion in the study by an investigator for
other reasons.
Age minimum:
20 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Jaundice
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Intervention(s)
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Procedure: Biliary drainage
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Primary Outcome(s)
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Time to recurrent biliary obstruction
[Time Frame: Up to 1 year]
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Secondary Outcome(s)
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Functional success rate of biliary drainage
[Time Frame: 2 weeks]
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Survival time
[Time Frame: Up to 2 year]
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Causes of recurrent biliary obstruction
[Time Frame: Up to 1 year]
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Procedure-related complication of biliary drainage and duodenal meta stent placement (type and severity)
[Time Frame: 30 days]
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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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