UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032154 |
|---|---|
| Receipt number | R000036682 |
| Scientific Title | Efficacy and safety of peroral direct cholangioscopy with an ultrathin endoscope for biliary disease. |
| Date of disclosure of the study information | 2018/04/09 |
| Last modified on | 2022/01/05 14:21:37 |
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Basic information
Public title
Efficacy and safety of peroral direct cholangioscopy with an ultrathin endoscope for biliary disease.
Acronym
Efficacy and safety of cholangioscopy for biliary disease
Scientific Title
Efficacy and safety of peroral direct cholangioscopy with an ultrathin endoscope for biliary disease.
Scientific Title:Acronym
Efficacy and safety of cholangioscopy for biliary disease
Region
| Japan |
Condition
Condition
Biliary disease
Classification by specialty
| Hepato-biliary-pancreatic medicine | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety of peroral direct cholangioscopy with an ultrathin endoscope for biliary disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visibility of biliary lesion
(using LCI and BLI)
Key secondary outcomes
1.Success rate of scope insertion to bile duct
2.Ability to procedure(forceps biopsy etc)
3.Procedure time
4.Adverse event
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1. Patient need to examine the biliary lesion with cholangioscopy.
2. Possible to get written informed consent from patients.
3. Ages 20 and older.
Key exclusion criteria
1. The size of bile duct less than 8mm on ERC
2. Patients with performance status 3 or 4
3. Patients with severe complications to other organs.
4. Patients with severe coagulation dysfunction.
5. Patients without informed consent.
6. Patients judged inappropriate by chief medical examiner.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironari Kato |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology
Zip code
Address
2-5-1 Shikata-cho,Kita-ku Okayama-city Okayama
TEL
086-235-7219
drkatocha@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuyuki Matsumoto |
Organization
Okayama University Hospital
Division name
Department of Endoscopy
Zip code
Address
2-5-1 Shikata-cho,Kita-ku Okayama-city Okayama
TEL
086-235-7219
Homepage URL
matsumotokazuyuki0227@yahoo.co.jp
Sponsor or person
Institute
Okayama university hospital
Institute
Department
Personal name
Funding Source
Organization
Okayama university hospital
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
| 2018 | Year | 04 | 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
9
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
| 2018 | Year | 03 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 01 | Month | 31 | Day |
Other
Other related information
Primaly endopoint
Visibility of biliary lesion
(using LCI and BLI)
Secondary endopoints
1.Success rate of scope insertion to bile duct
2.Ability to procedure(forceps biopsy etc)
3.Procedure time
4. Adverse event
Management information
Registered date
| 2018 | Year | 04 | Month | 08 | Day |
Last modified on
| 2022 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036682
