UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008118 |
|---|---|
| Receipt number | R000009555 |
| Scientific Title | Single center, randomized comparison test among single blind groups about availability and safety of Endoscopic Nasobiliary Drainage (ENBD) tube leading methods to nasal cavity |
| Date of disclosure of the study information | 2012/06/07 |
| Last modified on | 2012/10/02 13:08:59 |
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Basic information
Public title
Single center, randomized comparison test among single blind groups about availability and safety of Endoscopic Nasobiliary Drainage (ENBD) tube leading methods to nasal cavity
Acronym
Comparison test about Endoscopic Nasobiliary Drainage (ENBD) tube leading methods to nasal cavity
Scientific Title
Single center, randomized comparison test among single blind groups about availability and safety of Endoscopic Nasobiliary Drainage (ENBD) tube leading methods to nasal cavity
Scientific Title:Acronym
Comparison test about Endoscopic Nasobiliary Drainage (ENBD) tube leading methods to nasal cavity
Region
| Japan |
Condition
Condition
biliary and pancreatic disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We compare and investigate the three methods to lead ENBD tube to nasal cavity.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
leading time
Key secondary outcomes
frequency of vomiting
X-raying time
complication
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Randomized 20 cases are led ENBD tube by finger.
Interventions/Control_2
Randomized 20 cases are led ENBD tube by Guide Wire.
Interventions/Control_3
Randomized 20 cases are led ENBD tube by magnet.
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
the patients with indication of ENBD
Key exclusion criteria
the patients who implanted pacemakers
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Watanabe Seitaro |
Organization
Yokohama City University Hospital
Division name
Gastroenterology Division
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Watanabe Seitaro |
Organization
Yokohama City University Hospital
Division name
Gastroenterology Division
Zip code
Address
TEL
045-787-2640
Homepage URL
Sponsor or person
Institute
Yokohama City University, Gastroenterology Division
Institute
Department
Personal name
Funding Source
Organization
no
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 | 06 | Month | 07 | 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
| 2012 | Year | 06 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 07 | Day |
Last modified on
| 2012 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009555
