UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033801 |
|---|---|
| Receipt number | R000038509 |
| Scientific Title | A prospective study to diagnose the biliary stricture using cholangioscope and Probe-based confocal laser endomicroscopy (pCLE) |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2019/12/25 12:28:48 |
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Basic information
Public title
A prospective study to diagnose the biliary stricture using cholangioscope and Probe-based confocal laser endomicroscopy (pCLE)
Acronym
A prospective study to diagnose the biliary stricture using cholangioscope and Probe-based confocal laser endomicroscopy (pCLE)
Scientific Title
A prospective study to diagnose the biliary stricture using cholangioscope and Probe-based confocal laser endomicroscopy (pCLE)
Scientific Title:Acronym
A prospective study to diagnose the biliary stricture using cholangioscope and Probe-based confocal laser endomicroscopy (pCLE)
Region
| Japan |
Condition
Condition
biliary stricture
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the accuracy of cholangioscopy and confocal laser endomicroscopy imaging on the diagnosis of biliary stricture
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
accuracy of diagnosis
Key secondary outcomes
findings of cholangioscopy and confocal laser endomicroscopy imaging
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Patients with biliary stricture undergo cholangioscopy and confocal laser endomicroscopy imaging for diagnosis,then they will be histologically evaluated.
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
The patient with biliary stricture who needs diagnosis or treatment by ERCP.
Key exclusion criteria
The patient with no other serious complications and cholangitis.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tanisaka Yuki |
Organization
Saitama Medical University International Medical Center
Division name
Department of gastroenterology
Zip code
Address
1397-1, Yamane, Hidaka, Saitama
TEL
042-984-4111
tanisaka1205@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tanisaka Yuki |
Organization
Saitama Medical University International Medical Center
Division name
Department of gastroenterology
Zip code
Address
1397-1, Yamane, Hidaka, Saitama
TEL
042-984-4111
Homepage URL
tanisaka1205@gmail.com
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Boston Scientific Corporation
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | 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
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 19 | Day |
Last modified on
| 2019 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038509
