UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045359 |
|---|---|
| Receipt number | R000050502 |
| Scientific Title | validation study of an endoscopic diagnosis algorithm for duodenal lesion using magnified endoscopic examination with image-enhanced endoscopy |
| Date of disclosure of the study information | 2021/09/02 |
| Last modified on | 2026/03/14 18:31:00 |
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Basic information
Public title
validation study of an endoscopic diagnosis algorithm for duodenal lesion using magnified endoscopic examination with image-enhanced endoscopy
Acronym
VED study
Scientific Title
validation study of an endoscopic diagnosis algorithm for duodenal lesion using magnified endoscopic examination with image-enhanced endoscopy
Scientific Title:Acronym
VED study
Region
| Japan |
Condition
Condition
duodenal lesions
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We suggested a diagnostic algorithm for duodenal lesion using magnified endoscopic examination with image-enhanced endoscopy.
We will prospectively validate the efficacy of the algorithm on neoplastic lesions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy for neoplastic lesions of our suggested diagnostic algorithm
Key secondary outcomes
To validate following items of our suggested diagnostic algorithm.
1) sensitivity / specificity / positive predictive value / negative predictive value for neoplastic lesions
2) sensitivity / specificity / positive predictive value / negative predictive value for non neoplastic lesions
3) differences in diagnostic rates by endoscopic diagnostic proficiency
4) differences in diagnostic rates by endoscope equipment
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
patients undergoing upper gastrointestinal endoscopy at our hospital oncology center, division of research and development for minimally invasive therapy
Key exclusion criteria
1) patients with impossibility for the adaptation according to the guideline for antithrombotic drugs of japanese gastroenterological endoscopy society
2) patients with disorder about the function of blood coaglation
3) patients with severe organ dysfunction
4) patients with a history of upper gastrointestinal surgery
5) familial adenomatous polyposis patients
6) lesions for which biopsy has already been performed
7) lesions diagnosed as submucosal tumor, erosion or ulcer by endoscopist
8) patients who have already entered this study once during the study period
9) patients with another inappropreate reasons judged by the doctor
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Motohiko |
| Middle name | |
| Last name | Kato |
Organization
Keio University, school of medicine
Division name
Cancer center, division of research and development for minimal invasive treatment
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
anakayama34@keio.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Kubosawa |
Organization
Keio University, school of medicine
Division name
Gastroenterology
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
Homepage URL
yoooko102@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University, school of medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
keio-ctr-coijim@adst.keio.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
| 2021 | Year | 09 | Month | 02 | 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
696
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
The accuracy was 85.7% in the endoscopic differential diagnosis of tumor-non-tumor in colorectal lesions (Iwatate M et al. Dig Endosc. 2018; 30: 642-651.) and our previous report of the endoscopic differential diagnosis algorithm of tumor-non-tumor in duodenal lesions (Nakayama A et al. J Gastroenterol. 2022; 57: 164-173.), the accuracy was 92.2%. In this validation study, the lower limit of the 95% confidence interval for the accuracy was greater than 85.7%, a = 0.05, and b = 0.20. The required sample size was calculated to be 216 cases. Taking into account the fact that some dropout cases may occur, the sample size was set at 250 cases.
Esophagogastroduodenoscopy was performed in 696 patients, 261 of whom had duodenal lesions. Of these, 5 patients with lesions larger than 20 mm in diameter, 3 patients for whom detailed images could not be obtained, 2 patients with familial adenomatous polyposis, and 1 patient who was taking multiple antithrombotic drugs were excluded, resulting in a total of 250 cases. Of these, 6 cases of duodenal tumor not treated by endoscopy, 2 cases of non-tumor not biopsied, and 1 case in which pathological diagnosis was not possible based on biopsy specimen were excluded, for a total of 9 cases, 241 cases were finally included in the analysis.
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
When we find duodenal lesions during upper gastrointestinal endoscopy procedure, we diagnose them according to our diagnostic algorithm using magnified endoscopic examination with image-enhanced endoscopy.
Lesions diagnosed as non neoplastic lesions are taken biopsy. Lesions diagnosed as neoplastic lesions are treated at a later date.
We calculate the accuracy of diagnosis using histopathological results and validate the efficacy of the algorithm.
Recruitment of study participants and data analysis have now been completed. The manuscript is currently under submission.
Management information
Registered date
| 2021 | Year | 09 | Month | 02 | Day |
Last modified on
| 2026 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050502
