UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036199 |
|---|---|
| Receipt number | 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 12:53:29 |
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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
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
pt77172s@okayama-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Okayama University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041235
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
