Unique ID issued by UMIN | UMIN000045359 |
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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 | 2024/01/05 16:14:18 |
validation study of an endoscopic diagnosis algorithm for duodenal lesion using magnified endoscopic examination with image-enhanced endoscopy
VED study
validation study of an endoscopic diagnosis algorithm for duodenal lesion using magnified endoscopic examination with image-enhanced endoscopy
VED study
Japan |
duodenal lesions
Gastroenterology |
Malignancy
NO
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.
Efficacy
Confirmatory
Accuracy for neoplastic lesions of our suggested diagnostic algorithm
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
Observational
20 | years-old | <= |
Not applicable |
Male and Female
patients undergoing upper gastrointestinal endoscopy at our hospital oncology center, division of research and development for minimally invasive therapy
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
1000
1st name | Motohiko |
Middle name | |
Last name | Kato |
Keio University, school of medicine
Cancer center, division of research and development for minimal invasive treatment
1608582
35 Shinanomachi, Shinjuku-ku, Tokyo
0333531211
anakayama34@keio.jp
1st name | Yoko |
Middle name | |
Last name | Kubosawa |
Keio University, school of medicine
Gastroenterology
1608582
35 Shinanomachi, Shinjuku-ku, Tokyo
0333531211
yoooko102@keio.jp
Keio University
self funding
Self funding
Keio University, school of medicine
35 Shinanomachi, Shinjuku-ku, Tokyo
03-3353-1211
keio-ctr-coijim@adst.keio.ac.jp
NO
2021 | Year | 09 | Month | 02 | Day |
Unpublished
No longer recruiting
2021 | Year | 08 | Month | 31 | Day |
2021 | Year | 08 | Month | 31 | Day |
2022 | Year | 05 | Month | 18 | Day |
2025 | Year | 03 | Month | 31 | Day |
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.
2021 | Year | 09 | Month | 02 | Day |
2024 | Year | 01 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050502
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