UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044743 |
|---|---|
| Receipt number | R000049510 |
| Scientific Title | Analysis of endocytoscopic images of superficial non-ampullary duodenal epithelial tumors(SNADETs) |
| Date of disclosure of the study information | 2021/07/10 |
| Last modified on | 2023/05/08 12:50:54 |
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Basic information
Public title
Analysis of endocytoscopic images of duodenal tumors
Acronym
ANIMAGE-DUO study
Scientific Title
Analysis of endocytoscopic images of superficial non-ampullary duodenal epithelial tumors(SNADETs)
Scientific Title:Acronym
ANIMAGE-DUO study
Region
| Japan |
Condition
Condition
superficial non-ampullary duodenal epithelial tumors(SNADETs)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the correlation between ECS images of SNADETs analysed using computer and histopathological findings
Basic objectives2
Others
Basic objectives -Others
To establish of diagnostic algorithm using ECS of SNADETs
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation of number of glandular structures in images between ECS and histopathology
Key secondary outcomes
1.Difference in the number of nuclei in images between ECS and histopathology
2.Difference in the number of nuclei per unit area of ECS images according to histological diagnosis
3.Differences in nuclear roundness and aspect ratio of ECS images according to histological diagnosis
4.Difference in nuclear area per image of ECS images according to histological diagnosis
5. Difference in nuclear area per unit of ECS images according to histological diagnosis
6. Dispersity of nuclei of ECS images according to histological diagnosis
7. Diagnostic ability (sensitivity, specificity, positive predictive value, negative predictive value, diagnostic accuracy) of ECS images of SNADETs (nucleus area, number of nuclei, number of ducts)
8. Diagnostic accuracy of magnified endoscopic images
9. Difference of microvascular pattern in magnified endoscopic images.
10. Distribution of WOS in magnified endoscopic findings by histopathological diagnosis
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
1)patients who were confirmed pathological diagnosis by biopsy or resected specimens
2)patient who doesn't reject participation to this study
Key exclusion criteria
inappropriate patients who are judged by chief of researchers
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Shoko |
| Middle name | |
| Last name | Ono |
Organization
Hokkaido University Hospital
Division name
Division of Endoscopy
Zip code
0608648
Address
Kita14, Nishi5, Kita-Ku, Sapporo
TEL
+81-11-716-1161
onosho@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Marina |
| Middle name | |
| Last name | Kubo |
Organization
Hokkaido University Hospital
Division name
Division of Endoscopy
Zip code
0608648
Address
Kita14, Nishi5, Kita-Ku, Sapporo
TEL
+81-11-716-1161
Homepage URL
marina.2kb.83@gmail.com
Sponsor or person
Institute
Division of Endoscopy, Hokkaido 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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita14, Nishi5, Kita-Ku, Sapporo, Hokkaido, Japan
Tel
+81-11-716-1161
crjimu@huhp.hokudai.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
北海道大学病院（Hokkaido University Hospital）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
http://doi.org/10.1111/jgh.16207
Publication of results
Published
Result
URL related to results and publications
http://doi.org/10.1111/jgh.16207
Number of participants that the trial has enrolled
70
Results
Endocytoscopic images of SNADETs reflect histopathological atypia, and computer analysis provides a practical diagnostic algorithm for endoscopic intervention.
Results date posted
| 2023 | Year | 05 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Between January 2017 and July 2021, consecutive patients who underwent ECS for diagnosing duodenal lesions and who were histopathologically diagnosed at our hospital were retrospectively analyzed.
Participant flow
Figure 3 on "http://doi.org/10.1111/jgh.16207" .
Adverse events
There was no adverse event.
Outcome measures
Correlations in DSMs and glands between endocytoscopy and histological images were analyzed. The numbers of glands and densely stained areas with methylene blue (DSMs) per 1 mm2 and the percentage of DSMs per screen in endocytoscopy were determined.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
nothing particular
Management information
Registered date
| 2021 | Year | 07 | Month | 02 | Day |
Last modified on
| 2023 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049510
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