UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040690 |
|---|---|
| Receipt number | R000046442 |
| Scientific Title | A Japanese multicenter observational study to evaluate factors affecting colonoscopy outcomes (J-SCOUT study) |
| Date of disclosure of the study information | 2020/06/08 |
| Last modified on | 2025/06/12 16:57:57 |
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Basic information
Public title
A Japanese multicenter observational study to evaluate factors affecting colonoscopy outcomes (J-SCOUT study)
Acronym
A Japanese multicenter observational study to evaluate factors affecting colonoscopy outcomes (J-SCOUT study)
Scientific Title
A Japanese multicenter observational study to evaluate factors affecting colonoscopy outcomes (J-SCOUT study)
Scientific Title:Acronym
A Japanese multicenter observational study to evaluate factors affecting colonoscopy outcomes (J-SCOUT study)
Region
| Japan |
Condition
Condition
Colorectal cancer, colorectal polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate factors affecting colonoscopy outcomes in Japan
Basic objectives2
Others
Basic objectives -Others
factor analysis
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
adenoma detection rate
Key secondary outcomes
polyp detection rate, invasive cancer detection rate, advanced neoplasia detection rate, sessile serrated lesion detection rate, neuroendocrine tumor detection rate, flat and depressed lesion detection rate, the total number of adenomas per colonoscopy, cecal intubation rate, and complication rate
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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Subjects who underwent colonoscopy from April 2010 to March 2020
(2) Subjects over 20 years old
Key exclusion criteria
(1) Those who refuse to participate
(2) Those who underwent colonoscopy during the period when the endoscopic database of each hospital is not in place
(3) Those who underwent colonoscopy within 6 months
(4) Those who underwent colonoscopy for the purpose of detailed examination or treatment of colorectal lesions that were already pointed out
(5) Those who diagnosed with inflammatory bowel disease such as ulcerative colitis or Crohn's disease
(6) Those who underwent colonoscopy as an emergent endoscopy
(7) Others
Target sample size
150000
Research contact person
Name of lead principal investigator
| 1st name | Kiyohito |
| Middle name | |
| Last name | Tanaka |
Organization
Japan Gastroenterological Endoscopy Society
Division name
Japan Endoscopy Database Project
Zip code
101-0062
Address
Shin-ochanomizu Urban Trinity Bldg. 4F, 3-2-1 Kandasurugadai, Chiyoda-ku, Tokyo 101-0062, Japan
TEL
03-3525-4670
seijin7705@gmail.com
Public contact
Name of contact person
| 1st name | Takuji |
| Middle name | |
| Last name | Kawamura |
Organization
Kyoto Second Red Cross Hospital
Division name
Department of Gastroenterology
Zip code
602-8026
Address
355-5, Haruobi-cho, Kamigyo-ku, Kyoto 602-8026, JAPAN
TEL
075-231-5171
Homepage URL
kawamurat@kyoto2.jrc.or.jp
Sponsor or person
Institute
Japan Gastroenterological Endoscopy Society
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Gastroenterological Endoscopy Society
Address
Shin-ochanomizu Urban Trinity Bldg. 4F, 3-2-1 Kandasurugadai, Chiyoda-ku, Tokyo 101-0062, Japan
Tel
03-3525-4670
jges-rinri@jges.or.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
大阪国際がんセンター（大阪府）、尾田胃腸内科・内科（熊本県）、北里大学（神奈川県）、京都大学（京都府）、京都第二赤十字病院（京都府）、国立がん研究センター中央病院（東京都）、国立がん研究センター東病院（千葉県）、静岡医療センター（静岡県）、東京慈恵会医科大学葛飾医療センター（東京都）、東京大学（東京都）、京都府立医科大学（京都府）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 08 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/den.14721
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/den.14721
Number of participants that the trial has enrolled
47705
Results
Individual mean colonoscopy insertion time was associated with ADR and might be considered as a colonoscopy quality indicator as well as withdrawal time.
Results date posted
| 2025 | Year | 06 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The majority of patients were men (55%) in their 70s. Approximately one-third of the patients underwent colonoscopy for the first time, and the most common indications for examination were screening, positive fecal immunochemistry test (FIT), and surveillance after endoscopic treatment. Only 4.7% of the cases had poor bowel preparation, and in most cases, good bowel preparation status was obtained.
Participant flow
Of the 186,293 examinations, 82,005 cases were included after excluding those who met the exclusion criteria. Of these, 47,705 cases were analyzed for ADR, excluding data from four hospitals where polyps were not removed at the time of examination.
Adverse events
N/A
Outcome measures
adenoma detection rate
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 07 | Day |
Date of closure to data entry
| 2022 | Year | 06 | Month | 07 | Day |
Date trial data considered complete
| 2022 | Year | 06 | Month | 07 | Day |
Date analysis concluded
| 2025 | Year | 06 | Month | 07 | Day |
Other
Other related information
A multicenter observational study using large-scale endoscopy database
Management information
Registered date
| 2020 | Year | 06 | Month | 08 | Day |
Last modified on
| 2025 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046442
