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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023450
Receipt No. 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

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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
Email 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
Email kumdsh@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute Digestive and Lifestyle Diseases, Kagoshima University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027023

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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