UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023450 |
|---|---|
| Receipt number | R000027023 |
| Scientific Title | Efficacy and safety of cholangiopancreatoscopy: multicenter prospective observation study |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2017/02/22 16:29:50 |
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Basic information
Public title
Efficacy and safety of cholangiopancreatoscopy: multicenter prospective observation study
Acronym
Efficacy and safety of cholangiopancreatoscopy
Scientific Title
Efficacy and safety of cholangiopancreatoscopy: multicenter prospective observation study
Scientific Title:Acronym
Efficacy and safety of cholangiopancreatoscopy
Region
| Japan |
Condition
Condition
Pancreatobiliary diseases in need of cholangiopancreatoscopy
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of the cholangiopancreatoscopy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the success rate for the procedures by the cholangiopancreatoscopy
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
the diagnosis and treatment using the cholangiopancreatoscopy
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 patients with pancreatobiliary diseases are required for procedures by the cholangiopancreatoscopy and meet fllowing criteria:
(1) The patient written consent has been obtained.
(2) The patient over the age of 20.
Key exclusion criteria
(1) The patient has a severe comorbidity.
(2) The patient cannot be obtained with informed consent.
(3) The patient is pregnant.
(4) The patient prohibited the participant of this study by their research investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Hashimoto |
Organization
Kagoshima University
Division name
Digestive and Lifestyle Diseases
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima
TEL
0992755326
kumdsh@m.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Hashimoto |
Organization
Kagoshima University
Division name
Digestive and Lifestyle Diseases
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima
TEL
0992755326
Homepage URL
kumdsh@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Digestive and Lifestyle Diseases, Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
Digestive and Lifestyle Diseases, Kagoshima 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
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
| 2016 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | 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
| 2016 | Year | 08 | Month | 02 | Day |
Last modified on
| 2017 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027023
