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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036199
Receipt No. R000041235
Scientific Title Potential factors affecting technical failure and adverse event of short-type double balloon endoscope-assisted ERCP
Date of disclosure of the study information 2019/03/14
Last modified on 2019/03/14

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Basic information
Public title Potential factors affecting technical failure and adverse event of short-type double balloon endoscope-assisted ERCP
Acronym Potential factors affecting technical failure and adverse event of short-type DBE-ERCP
Scientific Title Potential factors affecting technical failure and adverse event of short-type double balloon endoscope-assisted ERCP
Scientific Title:Acronym Potential factors affecting technical failure and adverse event of short-type DBE-ERCP
Region
Japan

Condition
Condition pancreaticobiliary disease with surgical altered anatomy
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate factors affecting the technical success and adverse events of DBE-ERCP
Basic objectives2 Others
Basic objectives -Others factors affecting the technical success and adverse events
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Factors affecting the technical success of DBE-ERCP
Key secondary outcomes Factors affecting the adverse events of DBE-ERCP

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 Patients who underwent DBE-ERCP for pancreaticobiliary diseases
Key exclusion criteria 1. <20 years old patients
2. Patients who refusal to join
Target sample size 319

Research contact person
Name of lead principal investigator
1st name Hironari
Middle name
Last name Kato
Organization Okayama University Hospital
Division name Gastroenterology
Zip code 700-8558
Address 2-5-1, Shikata-cho, Kita-ku, Okayama
TEL 086-235-7219
Email yksk-tkhk@k8.dion.ne.jp

Public contact
Name of contact person
1st name Daisuke
Middle name
Last name Uchida
Organization Okayama University Hospital
Division name Gastroenterology
Zip code 700-8558
Address 2-5-1, Shikata-cho, Kita-ku, Okayama
TEL 086-235-7219
Homepage URL
Email pt77172s@okayama-u.ac.jp

Sponsor
Institute Department of Gastroenterology, Okayama University Hospital
Institute
Department

Funding Source
Organization Department of Gastroenterology, Okayama University Hospital
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 Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address 2-5-1, Shikata-cho, Kita-ku, Okayama
Tel 086-235-6938
Email mae6605@adm.okayama-u.ac.jp

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
2019 Year 03 Month 14 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 319
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 11 Month 19 Day
Date of IRB
2019 Year 01 Month 25 Day
Anticipated trial start date
2019 Year 01 Month 25 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a retrospective study, and all data have been assessed.

Management information
Registered date
2019 Year 03 Month 14 Day
Last modified on
2019 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041235

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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