Unique ID issued by UMIN | UMIN000052643 |
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Receipt number | R000058283 |
Scientific Title | Clinical performance evaluation of the landmark photo checker in upper gastrointestinal endoscopy |
Date of disclosure of the study information | 2023/12/31 |
Last modified on | 2024/01/28 16:41:20 |
Clinical performance evaluation of the landmark photo checker in upper gastrointestinal endoscopy
Clinical performance evaluation of the landmark photo checker in upper gastrointestinal endoscopy
Clinical performance evaluation of the landmark photo checker in upper gastrointestinal endoscopy
Clinical performance evaluation of the landmark photo checker in upper gastrointestinal endoscopy
Japan |
Non-disabled individuals
Gastroenterology |
Others
NO
To support proper photodocumentation during screening exams, a new artificial Intelligence system (AI) function called the Landmark Photo Checker (LMPC) has been implemented in CAD EYETM (FUJIFILM. Co, Tokyo). This endoscopic AI function facilitates endoscopic photodocumentation by providing a visual indication of completion when appropriate still images of seven anatomical landmarks in the stomach (including the oesophagogastric junction, cardia and fundus, cardia near field view, body greater curvature forward view, body lesser curvature retroflex view, angulus, and pylorus near field view) are captured during the exam. This study is an evaluation of the performance of the LMPC in clinical practice.
Efficacy
Confirmatory
Pragmatic
Not applicable
This study aimed to evaluate the sensitivity of LMPC for these seven landmarks as the primary endpoint.
The secondary evaluation criteria were defined as the specificity and diagnostic accuracy of LMPC.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Diagnosis
Maneuver |
The participants were randomly assigned to two groups of equal size: the sensitivity verification group and the specificity verification group. In the sensitivity verification group, the endoscopists captured appropriate still images of the seven landmarks during the examination. Conversely, in the specificity verification group, the endoscopists intentionally captured inappropriate images of the seven landmarks. Sensitivity was defined as the proportion of images marked as "good" by LMPC in the sensitivity verification group, while specificity was defined as the proportion of images not marked as "good" by LMPC in the specificity verification group.
28 | years-old | <= |
79 | years-old | >= |
Male and Female
Individuals who participated in this study, including asymptomatic individuals undergoing gastric endoscopy screening and upper gastrointestinal endoscopy recipients for surveillance purposes after Helicobacter pylori eradication, and provided written consent.
Patients after gastric surgery.
140
1st name | Hirotaka |
Middle name | |
Last name | Nakashima |
Foundation for Detection of Early Gastric Carcinoma
Kayabacho clinic
103-0025
2-6-12, Nihombashikayabacho, Chuo Ward, Tokyo, Japan
03-3668-6803
nakashima@soiken.or.jp
1st name | Hirotaka |
Middle name | |
Last name | Nakashima |
Foundation for Detection of Early Gastric Carcinoma
Kayabacho clinic
103-0025
2-6-12, Nihombashikayabacho, Chuo Ward, Tokyo, Japan
03-3668-6803
nakashima@soiken.or.jp
Foundation for Detection of Early Gastric Carcinoma
FUJIFILM Corporation
Profit organization
Foundation for Detection of Early Gastric Carcinoma
2-6-12, Nihombashikayabacho, Chuo Ward, Tokyo, Japan
03-3668-6803
nakashima@soiken.or.jp
NO
2023 | Year | 12 | Month | 31 | Day |
Unpublished
64
The sensitivity of the landmark was 85.7%. The specificity and accuracy rate, were 72.5% and 79.0%, respectively. The individual sensitivities (%) and specificities (%) for the seven landmarks were as follows: esophagogastric junction, 88.9 and 86.7; greater curvature of the cardia, 71.9 and 32.3; lesser curvature of the cardia, 84.4 and 53.1; greater curvature of the body, 90.6 and 90.3; lesser curvature of the body, 90.0 and 71.0; angle of the stomach, 86.2 and 87.5; and pylorus, 89.3 and 87.1.
2023 | Year | 09 | Month | 20 | Day |
This study aimed to evaluate the sensitivity of LMPC for these seven landmarks as the primary endpoint, with specificity and accuracy rate as secondary endpoints.
No longer recruiting
2023 | Year | 01 | Month | 15 | Day |
2023 | Year | 02 | Month | 02 | Day |
2023 | Year | 03 | Month | 01 | Day |
2024 | Year | 01 | Month | 31 | Day |
2023 | Year | 10 | Month | 29 | Day |
2024 | Year | 01 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058283
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