UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009415 |
|---|---|
| Receipt number | R000005570 |
| Scientific Title | A randomized-controlled trial concerning effectiveness and safety of 4Fr.ENPBD |
| Date of disclosure of the study information | 2012/11/27 |
| Last modified on | 2019/07/31 20:09:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A randomized-controlled trial concerning effectiveness and safety of 4Fr.ENPBD
Acronym
A randomized-controlled trial of 4Fr.ENPBD
Scientific Title
A randomized-controlled trial concerning effectiveness and safety of 4Fr.ENPBD
Scientific Title:Acronym
A randomized-controlled trial of 4Fr.ENPBD
Region
| Japan |
Condition
Condition
Disease for which biliary or pancreatic duct drainage is necessary
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Compare the safety of 4Fr.ENPBD to that of 6Fr.ENBD and 5Fr.ENPD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of acute pancreatitis and hyperpancreaticamylasemia post placement of ENPBD
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
4Fr.ENPBD
Interventions/Control_2
5Fr.ENPD and 6Fr.ENBD
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are expected to use ENPBD tube
Key exclusion criteria
Patients who have history of EST or EPBD.
Patients who are expected to be undergone EST or EPBD.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sasaki Tamito |
Organization
Hiroshima university hospital
Division name
Department of Gastroenterology and metabolism
Zip code
Address
Kasumi 1-2-3, minami-ku, hiroshima-shi
TEL
082-257-5591
suiken@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ishigaki Takashi |
Organization
Hiroshima University
Division name
Department of Medicine and Molecular Science
Zip code
Address
Kasumi 1-2-3, minami-ku, hiroshima-shi
TEL
082-257-5591
Homepage URL
suiken@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and metabolism of Hiroshima university hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
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 | 11 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2010 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2011 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 27 | Day |
Last modified on
| 2019 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005570
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
