UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044325 |
|---|---|
| Receipt number | R000050626 |
| Scientific Title | Retrospective study of endoscopic diagnosis and treatment of gastrointestinal and pancreaticobiliary lesions |
| Date of disclosure of the study information | 2021/05/25 |
| Last modified on | 2021/05/25 19:06:11 |
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Basic information
Public title
Retrospective study of endoscopic diagnosis and treatment of gastrointestinal and pancreaticobiliary lesions
Acronym
Retrospective study of endoscopic diagnosis and treatment of gastrointestinal and pancreaticobiliary lesions
Scientific Title
Retrospective study of endoscopic diagnosis and treatment of gastrointestinal and pancreaticobiliary lesions
Scientific Title:Acronym
Retrospective study of endoscopic diagnosis and treatment of gastrointestinal and pancreaticobiliary lesions
Region
| Japan |
Condition
Condition
Gastrointestinal tract disease (Neoplastic lesion and Non-neoplastic lesion)
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this project is to evaluate the endoscopic diagnosis of gastrointestinal lesions, their relationship to various comorbidities, identification and evaluation of risk factors for complications, safety and efficacy of endoscopic examinations and endoscopic treatment, and short- and long-term prognosis, and to build an academic reference for the development of diagnostic criteria and treatment guidelines for endoscopic practice.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient Background(patient details and lesion details), Overview of tests and test results, Overview and results of endoscopic treatments and procedures and Long-term results after testing and treatment
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 cases where gastrointestinal endoscopy was performed at our hospital
Key exclusion criteria
Nothing
Target sample size
500000
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Dobashi |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
105-8461
Address
3-25-8 Nishi Shinbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
03-3433-1111
akira.dobashi1980@gmail.com
Public contact
Name of contact person
| 1st name | Matsui |
| Middle name | |
| Last name | Hiroaki |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
105-8461
Address
3-25-8 Nishi Shinbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
03-3433-1111
Homepage URL
hiro24tht80@yahoo.co.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Jikei University School of Medicine
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
The Jikei University School of Medicine
Address
3-25-8 Nishi Shinbashi, Minato-ku, Tokyo 105-8461, Japan
Tel
03-3433-1111
hiro24tht80@yahoo.co.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
| 2021 | Year | 05 | Month | 25 | 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
| 2019 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective analysis
Management information
Registered date
| 2021 | Year | 05 | Month | 25 | Day |
Last modified on
| 2021 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050626
