UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008288 |
|---|---|
| Receipt number | R000009569 |
| Scientific Title | Effect of tube aperture in endoscopic naso-biliary drainage against obstructive jaundice |
| Date of disclosure of the study information | 2012/07/01 |
| Last modified on | 2018/08/15 13:08:51 |
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Basic information
Public title
Effect of tube aperture in endoscopic naso-biliary drainage against obstructive jaundice
Acronym
Tube aperture in ENBD
Scientific Title
Effect of tube aperture in endoscopic naso-biliary drainage against obstructive jaundice
Scientific Title:Acronym
Tube aperture in ENBD
Region
| Japan |
Condition
Condition
obstructive jaundice
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy and complications of ENBD tubes with different apertures
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
decrease in serum bilirubin level after ENBD treatment
Key secondary outcomes
complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
7Fr-endoscopic nasobiliary drainage tube
Interventions/Control_2
5Fr-endoscopic nasobiliary drainage tube
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
cases with obstructive jaundice who needs interventions
Key exclusion criteria
failure to obain written informed consent
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Matsuhashi |
Organization
NTT Medical Center Tokyo
Division name
Department of Gastroenterology
Zip code
Address
5-9-22 Higashi-gotanda, Shinagawa-ku, Tokyo
TEL
03-3448-6248
nmatuha-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Matsuhashi |
Organization
NTT Medical Center Tokyo
Division name
Department of Gastroenterology
Zip code
Address
5-9-22 Higashi-gotanda, Shinagawa-ku, Tokyo
TEL
03-3448-6248
Homepage URL
nmatuha-tky@umin.ac.jp
Sponsor or person
Institute
NTT Medical Center Tokyo
Institute
Department
Personal name
Funding Source
Organization
NTT Medical Center Tokyo
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2012 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2012 | Year | 06 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 28 | Day |
Last modified on
| 2018 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009569
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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