UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009291 |
|---|---|
| Receipt number | R000010734 |
| Scientific Title | A prospective randomized controlled trial of wire guided biliary cannulayion using J tip and straight tip guidewire. |
| Date of disclosure of the study information | 2012/11/09 |
| Last modified on | 2013/12/10 20:22:58 |
* 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 prospective randomized controlled trial of wire guided biliary cannulayion using J tip and straight tip guidewire.
Acronym
A prospective randomized controlled trial of WGC using J and straight tip guidewire.
Scientific Title
A prospective randomized controlled trial of wire guided biliary cannulayion using J tip and straight tip guidewire.
Scientific Title:Acronym
A prospective randomized controlled trial of WGC using J and straight tip guidewire.
Region
| Japan |
Condition
Condition
Biliary and pancreatic diseases requiring biliary tract catheter insertion.
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of the successful insertion rate between J and straight tip guidewire for WGC.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Successful insertion rate
Key secondary outcomes
Complication rate
Time of deep cannulation
Cost
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Biliary cannulation in WGC using J tip guidewire
Interventions/Control_2
Biliary cannulation in WGC using straight tip guidewire
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 biluary tract catheter insertion, with no history of duodenal papilla treatment.
(2)Patients who understand and are willing to give a written informed consent about participation.
Key exclusion criteria
(1)Patients with gastrectomy by Billroth II and Roux-en-Y renstruction
(2)Patients in Perfomance status 4
(3)Patients require ERP
(4)Patients with severe complication inother organs
(5)Patients judged by principal investigator to be inadequate as subjects
Target sample size
100
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, Kanagawa
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Yokohama City University Hospital
Division name
Gastroenterology Division
Zip code
Address
3-9 Fukuura, Kanazawa-ku Yokohama, Kanagawa
TEL
Homepage URL
Sponsor or person
Institute
Yokohama City University Hospital, Gastroenterology Division
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 | 09 | 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 | 10 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 22 | 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 | 11 | Month | 08 | Day |
Last modified on
| 2013 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010734
