UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018760 |
|---|---|
| Receipt number | R000021703 |
| Scientific Title | pCLE for pancreato-biliary diseases |
| Date of disclosure of the study information | 2015/08/21 |
| Last modified on | 2021/04/17 09:16:14 |
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Basic information
Public title
pCLE for pancreato-biliary diseases
Acronym
pCLE for pancreato-biliary diseases
Scientific Title
pCLE for pancreato-biliary diseases
Scientific Title:Acronym
pCLE for pancreato-biliary diseases
Region
| Japan |
Condition
Condition
pancreato-biliary diseases
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
primary endpoint, safety
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
safety
24hours after procedure
symptom
P.S.
Blood,RBC,Hb,Hct,WBC,Plt
Tbil,Alp,AST(GOT),ALT(GOT),GTP,LDH,BUN,Cre,AMY,P-AMY,Na,K,Cl,CRP
Key secondary outcomes
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
| Medicine |
Interventions/Control_1
Endoscopic diagnosis using pCLE
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. no main organ failure
2. PS 0-2
3. IC by the patient
Key exclusion criteria
1. easy bleeding
2. doctor 's opinion
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Hara |
Organization
Aichi Cancer Center Hospital
Division name
Gastroenterology
Zip code
Address
1-1 Kanokoden Tikusa-ku
TEL
052-762-6111
khara@aichi-cc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Hara |
Organization
ACC
Division name
Gastroenterology
Zip code
Address
1-1Kanokoden Tikusa-ku Nagoya
TEL
052-762-6111
Homepage URL
khara@aichi-cc.jp
Sponsor or person
Institute
ACC(Aichi Cancer Center Hospital)
Institute
Department
Personal name
Funding Source
Organization
ACC(Aichi Cancer Center Hospital)
Organization
Division
Category of Funding Organization
Local Government
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
| 2015 | Year | 08 | Month | 21 | 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
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 21 | Day |
Last modified on
| 2021 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021703
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
