UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046439 |
|---|---|
| Receipt number | R000052988 |
| Scientific Title | a retrospective clinical study of the efficacy of endoscopic biliary drainage using 4-Fr ENBD catheter. |
| Date of disclosure of the study information | 2021/12/24 |
| Last modified on | 2022/01/21 20:32:49 |
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Basic information
Public title
a retrospective clinical study of the efficacy of endoscopic biliary drainage using 4-Fr ENBD catheter.
Acronym
a retrospective clinical study of the efficacy of endoscopic biliary drainage using 4-Fr ENBD catheter.
Scientific Title
a retrospective clinical study of the efficacy of endoscopic biliary drainage using 4-Fr ENBD catheter.
Scientific Title:Acronym
a retrospective clinical study of the efficacy of endoscopic biliary drainage using 4-Fr ENBD catheter.
Region
| Japan |
Condition
Condition
biliary obstruction which is difficult to procedure biliary drainage using conventional drainage tube and alternatively try to procedure biliary drainage using 4-Fr ENBD catheters.
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
clarify the clinical efficacy of endoscopic biliary drainage using 4-Fr ENBD catheter.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
evaluate the technical success rate of endoscopic biliary drainage using 4-Fr catheters.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
biliary obstruction which was difficult to procedure endoscopic biliary drainage using conventional drainage tube and alternatively procedure endoscopic biliary drainage using 4-Fr ENBD catheters
Key exclusion criteria
cases which was underwent endoscopic biliary drainage use 4-Fr ENBD catheters for the purposes other than the above
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroo |
| Middle name | |
| Last name | Imazu |
Organization
Nihon University School of Medicine Itabashi Hospital
Division name
Division of Gastroenterology and Hepatology,
Zip code
173-8610
Address
30-1 Oyaguchikami-cho, Itabashi-ku, Tokyo
TEL
03-3972-8111
imazu.hiroo@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriyuki |
| Middle name | |
| Last name | Kuniyoshi |
Organization
Nihon University School of Medicine Itabashi Hospital
Division name
Division of Gastroenterology and Hepatology
Zip code
173-8610
Address
30-1 Oyaguchikami-cho, Itabashi-ku, Tokyo
TEL
03-3972-8111
Homepage URL
kuniyoshi.noriyuki@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine Itabashi Hospital
Institute
Department
Personal name
Funding Source
Organization
Nihon University School of Medicine Itabashi Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University School of Medicine Itabashi Hospital
Address
30-1 Oyaguchikami-cho, Itabashi-ku, Tokyo
Tel
03-3972-8111
kuniyoshi.noriyuki@nihon-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Basic information on the research subject, blood test values, imaging findings, time to small diameter tube occlusion, and contingencies
Management information
Registered date
| 2021 | Year | 12 | Month | 22 | Day |
Last modified on
| 2022 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052988
