UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044509 |
|---|---|
| Receipt number | R000050851 |
| Scientific Title | Research on bile duct biopsy for biliary tract diseases |
| Date of disclosure of the study information | 2021/07/01 |
| Last modified on | 2021/06/22 20:47:34 |
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Basic information
Public title
Research on bile duct biopsy for biliary tract diseases
Acronym
Research on bile duct biopsy for biliary tract diseases
Scientific Title
Research on bile duct biopsy for biliary tract diseases
Scientific Title:Acronym
Research on bile duct biopsy for biliary tract diseases
Region
| Japan |
Condition
Condition
Extrahepatic bile duct cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the results and safety of biopsy for bile duct stenosis using an endoscopic introducer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of Mapping Biopsy using endoscopic introducer (success rate of biopsy of targeted bile duct branch against expected operation)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Bile duct biopsy using an endoscopic introducer
Interventions/Control_2
Bile duct biopsy without an endoscopic introducer
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 suspected of having bile duct stenosis by imaging diagnosis such as CT or MRI and require ERCP.
Patients who have given written consent to participate in this study.
Key exclusion criteria
Patients with poorly controlled infections.
Patients with severe drug allergy.
Pregnant or potentially pregnant and lactating women.
Patients with severe mental disorders.
Cases that the principal investigator or sub-investigator deems inappropriate for the safe conduct of this study.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Kawashima |
Organization
Nagoya University Hospital
Division name
Department of Endoscopy
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
0527442602
h-kawa@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenta |
| Middle name | |
| Last name | Yamada |
Organization
Nagoya University Hospital
Division name
Department of Endoscopy
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
0527442602
Homepage URL
kentaymd@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
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
Ethics Committee
Address
65, Tsuruma-cho, Showa-ku, Nagoya
Tel
0527412111
ethics@med.nagoya-u.ac.jp
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
| 2021 | Year | 07 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 06 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2021 | Year | 06 | Month | 11 | Day |
Last modified on
| 2021 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050851
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
