UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016910 |
|---|---|
| Receipt number | R000012323 |
| Scientific Title | A randomized trial of usefulness for bile duct biopsy with holding guidewire |
| Date of disclosure of the study information | 2015/03/25 |
| Last modified on | 2015/03/25 12:55:54 |
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Basic information
Public title
A randomized trial of usefulness for bile duct biopsy with holding guidewire
Acronym
Bile duct biopsy RCT
Scientific Title
A randomized trial of usefulness for bile duct biopsy with holding guidewire
Scientific Title:Acronym
Bile duct biopsy RCT
Region
| Japan |
Condition
Condition
Bile duct tumor
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To asess the usefulness of bile duct biopsy with holding guidewire
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The success rate of sufficient tissue by biopsy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
biopsy with holding guidewire/normal biopsy
Interventions/Control_2
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
bile duct tumor
Key exclusion criteria
History of biliary sphinctectomy and endoscopic papillary balloon dilation
pre-procedure active pancreatitis
Failed biliary cannulation
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yamashita Yasunobu |
Organization
Wakayama Medical University
Division name
Second Department of Internal Medicine
Zip code
Address
811-1, Kimiidera, Wakayama city, Wakayama 641-0012, Japan
TEL
073-447-2300
yasunobu@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasunobu Yamashita |
Organization
Wakayama Medical University
Division name
Second Department of Internal Medicine
Zip code
Address
811-1, Kimiidera, Wakayama city, Wakayama 641-0012, Japan
TEL
0734472300
Homepage URL
yasunobu@wakayama-med.ac.jp
Sponsor or person
Institute
Second Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Second Department of Internal Medicine
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
和歌山県立医科大学病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 25 | 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
| 2013 | Year | 01 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | 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
| 2015 | Year | 03 | Month | 25 | Day |
Last modified on
| 2015 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012323
