UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037264 |
|---|---|
| Receipt number | R000042486 |
| Scientific Title | A comparison of image enhanced endoscopies for ulcerative colitis |
| Date of disclosure of the study information | 2019/07/04 |
| Last modified on | 2024/04/29 14:12:48 |
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Basic information
Public title
A comparison of image enhanced endoscopies for ulcerative colitis
Acronym
A comparison of image enhanced endoscopies for ulcerative colitis
Scientific Title
A comparison of image enhanced endoscopies for ulcerative colitis
Scientific Title:Acronym
A comparison of image enhanced endoscopies for ulcerative colitis
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify diagnostic accuracy of image enhanced endoscopies for assessment of ulcerative colitis activity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
diagnostic accuracy of image enhanced endoscopies for assessment of ulcerative colitis activity
Key secondary outcomes
diagnostic concordance rate for endoscopists
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
1)Patients with ulcerative colitis.
2)Patients who are indicated for endoscopic biopsy.
3)Patients with written informed consent.
Key exclusion criteria
1)Patients who are contraindicated for endoscopic biopsy.
Target sample size
201
Research contact person
Name of lead principal investigator
| 1st name | Mikihiro |
| Middle name | |
| Last name | Fujiya |
Organization
Asahikawa Medical University
Division name
Division of Gastroenterology and Hematology/Oncology, Department of Medicine
Zip code
078-8510
Address
2-1-1-1, Midorigaoka-higashi Asahikawa, Hokkaido, 078-8510, Japan
TEL
0166-68-2462
fjym@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Keitaro |
| Middle name | |
| Last name | Takahashi |
Organization
Asahikawa Medical University
Division name
Division of Gastroenterology and Hematology/Oncology, Department of Medicine
Zip code
078-8510
Address
2-1-1-1, Midorigaoka-higashi Asahikawa, Hokkaido, 078-8510, Japan
TEL
0166-68-2462
Homepage URL
ktakaha@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Division of Gastroenterology and Hematology/Oncology, Department of Medicine
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
Asahikawa Medical University
Address
2-1-1-1, Midorigaoka-higashi Asahikawa, Hokkaido, 078-8510, Japan
Tel
0166-68-2297
ktakaha@asahikawa-med.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 | 07 | Month | 04 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/full/10.1111/jgh.16586
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1111/jgh.16586
Number of participants that the trial has enrolled
81
Results
LCI and AFI offer comparable diagnostic accuracy for histological healing. However, LCI displayed higher sensitivity than AFI, while AFI showed higher specificity compared to LCI.
Results date posted
| 2024 | Year | 04 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 04 | Month | 27 | Day |
Baseline Characteristics
This study included 81 patients, resulting in a total of 204 endoscopic images obtained using LCI and AFI, respectively.
Participant flow
A total of 83 UC patients scheduled for lower gastrointestinal endoscopy were assessed for eligibility. Two of these patients were excluded from this study because they refused to undergo a second endoscopy after experiencing abdominal pain during the first one. Consequently, this study included 81 patients, resulting in a total of 204 endoscopic images obtained using LCI and AFI, respectively.
Adverse events
After endoscopic examination, abdominal pain was observed in two patients.
Outcome measures
The primary outcome was the diagnostic accuracy of image-enhanced endoscopies for assessing ulcerative colitis activity.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 07 | Month | 04 | Day |
Last modified on
| 2024 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042486
