UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040324 |
|---|---|
| Receipt number | R000044985 |
| Scientific Title | Retrospective study of the results of ERCP and related treatments. |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2022/05/09 12:55:05 |
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Basic information
Public title
Retrospective study of the results of ERCP and related treatments.
Acronym
Study of the results of ERCP and related treatments.
Scientific Title
Retrospective study of the results of ERCP and related treatments.
Scientific Title:Acronym
Study of the results of ERCP and related treatments.
Region
| Japan |
Condition
Condition
Hepato-biliary and pancreatic diseases
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Retrospective study of the results of ERCP and related treatments.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy(diagnostic accuracy) and Safety(complications)
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients who underwent ERCP
Key exclusion criteria
none
Target sample size
9500
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Takaoka |
Organization
Kansai Medical University Hospital
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
573-1191
Address
3-1, Shinmachi 2-chome, Hirakata city, Osaka pref 573-1191, Japan
TEL
072-804-0101
takaokam@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Takaoka |
Organization
Kansai Medical University Hospital
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
573-1191
Address
3-1, Shinmachi 2-chome, Hirakata city, Osaka pref 573-1191, Japan
TEL
072-804-0101
Homepage URL
takaokam@hirakata.kmu.ac.jp
Sponsor or person
Institute
Division of Gastroenterology and Hepatology, Department of Internal Medicine. Kansai Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Kansai Medical University Ethics Committee
Address
5-1, Shinmachi 2-chome, Hirakata city, Osaka pref 573-1191, Japan
Tel
072-804-0101
kenkyu@hirakata.kmu.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
| 2020 | Year | 06 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In ERCP and related treatments,
success rate, complications, success rate by treatment type, results of treatments, etc.
Extension of period Approval date:April/20 /2020
The subjects were expanded to the patients who received ERCP at Kansai Medical University Hospital, Kansai Medical University Kori Hospital and Kansai Medical University Medical Center. Approval date: April/11 /2022
Management information
Registered date
| 2020 | Year | 05 | Month | 07 | Day |
Last modified on
| 2022 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044985
