UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008208 |
|---|---|
| Receipt number | R000009675 |
| Scientific Title | Multi-Center Study on the Wire-Guided Biliary Cannulation Using J Tip and Angle Tip Guidewire. -Jangle Study- |
| Date of disclosure of the study information | 2012/06/19 |
| Last modified on | 2013/04/30 13:54:48 |
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Basic information
Public title
Multi-Center Study on the Wire-Guided Biliary Cannulation Using J Tip and Angle Tip Guidewire.
-Jangle Study-
Acronym
Jangle study
Scientific Title
Multi-Center Study on the Wire-Guided Biliary Cannulation Using J Tip and Angle Tip Guidewire.
-Jangle Study-
Scientific Title:Acronym
Jangle study
Region
| Japan |
Condition
Condition
Patients require biliary tract catheter insertion, with no history of duodenal papilla treatment.
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the usefulness of the J-shaped tip guide wire for WGC.
Primary evaluation: successful insertion rate.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Successful insertion rate
Key secondary outcomes
Kinds and frequency of complications
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
If the subjects meet the inclusion criteria, they will be registered on web before the entry. Decide the guide wire to use as the first choice (J-shaped tip) prior to the operation. If a deep catheter insertion into biliary tract was not achieved within 10 minutes after the start of treatment, change the guide wire to another type(angle tip guide wire) and continue the insertion another 10 minutes. (cross-over method)
Interventions/Control_2
If the subjects meet the inclusion criteria, they will be registered on web before the entry. Decide the guide wire to use as the first choice (angle tip guide wire) prior to the operation. If a deep catheter insertion into biliary tract was not achieved within 10 minutes after the start of treatment, change the guide wire to another type(J-shaped tip) and continue the insertion another 10 minutes. (cross-over method)
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
1) Patients require biliary tract catheter insertion, with no history of duodenal papilla treatment.
2) Patients consent to be included in the study based on his/her own free will after sufficient informing and understanding of the study.
Key exclusion criteria
1) Cases having difficulty in endoscopic approach
2) Cases in Perfomance status 4
3) Cases having a history of duodenal papilla treatment (post EST, EPBD)
4) Cases with gastrectomy
5) Cases with sever complication in other organs
6) Cases without informed consent
7) Cases judged by principal investigator to be inadequate as subjects
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayoshi Tsuchiya |
Organization
Tokyo Medical University Hospital
Division name
Department of the 4th Internal medicine (Gastroenterology and Hepatology)
Zip code
Address
6-7-1 Nishishijuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayoshi Tsuchiya |
Organization
Tokyo Medical University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
6-7-1 Nishishijuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
Homepage URL
tsuchiya@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University Hospital
Department of the 4th Internal medicine (Gastroenterology and Hepatology)
Institute
Department
Personal name
Funding Source
Organization
none
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
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
東京医科大学病院 （東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 19 | 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 | 05 | Month | 01 | 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 | 19 | Day |
Last modified on
| 2013 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009675
