UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016388 |
|---|---|
| Receipt number | R000019037 |
| Scientific Title | Development of endoscopic nasal biliary drainage tube alterable to internal drainage |
| Date of disclosure of the study information | 2015/01/30 |
| Last modified on | 2020/02/03 12:47:55 |
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Basic information
Public title
Development of endoscopic nasal biliary drainage tube alterable to internal drainage
Acronym
Development of ENBD alterable to internal drainage
Scientific Title
Development of endoscopic nasal biliary drainage tube alterable to internal drainage
Scientific Title:Acronym
Development of ENBD alterable to internal drainage
Region
| Japan |
Condition
Condition
Patients who need both detailed image and continuous drainage of biliary tract
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Development ofa novel ENBD alterable to internal drainage
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate
Key secondary outcomes
complication
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
Patients who need both detailed image and continuous drainage of biliary tract
Key exclusion criteria
1.Cases having difficulty in endoscopic approach
2.Cases with sever complication in other organs
3.Cases judged by principal investigator to be inadequate as subjects
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Mori |
Organization
Ichnomiya Nishi Hospital
Division name
Gastroenterology
Zip code
4940001
Address
1 Hira Kaimei Ichinomiya Aichi Japan
TEL
0586-48-0077
a-mori@anzu.or.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Mori |
Organization
Ichnomiya Nishi Hospital
Division name
Gastroenterology
Zip code
4940001
Address
1 Hira Kaimei Ichinomiya Aichi Japan
TEL
0586-48-0077
Homepage URL
http://www.anzu.or.jp
a-mori@anzu.or.jp
Sponsor or person
Institute
Department of the gastroenterology, Ichnomiya Nishi Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of the gastroenterology, Ichnomiya Nishi Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ichinomiya Nishi Hospital
Address
1 Hira Kaimei
Tel
0586480077
a-mori@anzu.or.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
| 2015 | Year | 01 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We developed the device of the ERCP-related procedure and evaluated the utility in daily ERCP
Management information
Registered date
| 2015 | Year | 01 | Month | 30 | Day |
Last modified on
| 2020 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019037
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
