UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052643 |
|---|---|
| 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 | 2025/04/29 10:47:23 |
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Basic information
Public title
Clinical performance evaluation of the landmark photo checker in upper gastrointestinal endoscopy
Acronym
Clinical performance evaluation of the landmark photo checker in upper gastrointestinal endoscopy
Scientific Title
Clinical performance evaluation of the landmark photo checker in upper gastrointestinal endoscopy
Scientific Title:Acronym
Clinical performance evaluation of the landmark photo checker in upper gastrointestinal endoscopy
Region
| Japan |
Condition
Condition
Non-disabled individuals
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
This study aimed to evaluate the sensitivity of LMPC for these seven landmarks as the primary endpoint.
Key secondary outcomes
The secondary evaluation criteria were defined as the specificity and diagnostic accuracy of LMPC.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
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.
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
| 28 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
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.
Key exclusion criteria
Patients after gastric surgery.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Hirotaka |
| Middle name | |
| Last name | Nakashima |
Organization
Foundation for Detection of Early Gastric Carcinoma
Division name
Kayabacho clinic
Zip code
103-0025
Address
2-6-12, Nihombashikayabacho, Chuo Ward, Tokyo, Japan
TEL
03-3668-6803
nakashima@soiken.or.jp
Public contact
Name of contact person
| 1st name | Hirotaka |
| Middle name | |
| Last name | Nakashima |
Organization
Foundation for Detection of Early Gastric Carcinoma
Division name
Kayabacho clinic
Zip code
103-0025
Address
2-6-12, Nihombashikayabacho, Chuo Ward, Tokyo, Japan
TEL
03-3668-6803
Homepage URL
nakashima@soiken.or.jp
Sponsor or person
Institute
Foundation for Detection of Early Gastric Carcinoma
Institute
Department
Personal name
Funding Source
Organization
FUJIFILM Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Foundation for Detection of Early Gastric Carcinoma
Address
2-6-12, Nihombashikayabacho, Chuo Ward, Tokyo, Japan
Tel
03-3668-6803
nakashima@soiken.or.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
| 2023 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
GIE, 2024, 99(6) Supplement: AB7-AB8
Publication of results
Published
Result
URL related to results and publications
GIE, 2024, 99(6) Supplement: AB7-AB8
Number of participants that the trial has enrolled
121
Results
The sensitivity of the landmark was 87.4%. The specificity and accuracy rate, were 75.5% and 81.9%, respectively. The individual sensitivities (%) and specificities (%) for the seven landmarks were as follows: esophagogastric junction, 93.0 and 92.0; cardia near field view, 80.0 and 66.6; cardia and fundus, 75.4 and 41.5; greater curvature of the body, 89.2 and 87.4; lesser curvature of the body, 94.9 and 79.2; angles, 88.1 and 83.3; and pylorus, 93.3 and 88.9.
Results date posted
| 2023 | Year | 09 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The inclusion criteria were (1) Cases where the purpose of the procedure was gastric endoscopic screening or examination, and (2) written informed consent was obtained. The exclusion criteria were (1) a history of gastric surgery and (2) cases with obvious gastrointestinal clinical symptoms.The study involved 121 participants, with an average age of 56.1 years, of whom 67 (55.4%) were male.
Participant flow
All 121 participants were randomly assigned to a sensitivity validation group (66 participants) or a specificity validation group (55 participants). Randomization was performed using the envelope method according to the recommendations in the CONSORT guidelines (the numbered container method). Random allocation messages were pre-generated by a computer program (the python random module) for each examination and placed in sealed envelopes with consecutive registration numbers. The endoscopists opened the envelopes sequentially for each eligible examination and assigned participants to either the sensitivity or specificity validation group based on the message inside the envelope.
Adverse events
None.
Outcome measures
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.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 29 | Day |
Last modified on
| 2025 | 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=R000058283
