Ignite Creation Date:
2024-07-17 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06495645
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-06-25
Brief Title:
Miss Rate of Gastric Neoplasms Under Computer-aided Endoscopy
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
Computer-aided Gastric Lesion Localization and Miss Rate of Gastric Neoplasms a Tandem Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This prospective randomized trial compares AI-assisted upper gastrointestinal endoscopy with high definition upper gastrointestinal endoscopy in term of missed rate of gastric neoplasm The investigators hypothesize the miss rate of high definition upper gastrointestinal endoscopy is higher than AI-assisted upper gastrointestinal endoscopy
Detailed Description:
Patients will be randomly assigned to begin with AI-assisted upper gastrointestinal endoscopy follow immediately by high definition HD upper gastrointestinal endoscopy AI-HD group or start with HD upper gastrointestinal endoscopy follow immediately by AI-assisted upper gastrointestinal endoscopy HD-AI group The random allocation sequence is generated by a computer-generated random numerical series with 1 representing the AI-HD group and 0 representing the HD-AI group Randomization is conducted in blocks of four at a 11 ratio stratified by indications screeningsurveillance vs others endoscopists experience experienced versus less experienced and mode of sedation unsedated vs sedated Experienced endoscopist is defined as qualified endoscopists with more than 7 years experience in upper endoscopy whereas less experienced endoscopists include fellows and trainees A research assistant not directly involved in this study maintained all randomization codes which are contained within individual opaque envelopes Upon obtaining patient consent the envelope will be opened to reveal the assigned examination sequence Patients remain blinded to their group allocation throughout the study but the performing endoscopist is aware of the assigned allocation
Participating endoscopists will receive training on the interpretation of real-time AI detection system as well as detection of dysplasia under HD endoscopy before performing study All patients will fast for at least 6 hours before the procedure All examinations will be performed with HD endoscopes ELUXEO 7000 video system Fujifilm Co Tokyo Japan under white light The artificial intelligence assisted gastric dysplasia localization system uses a graphical user interface for real-time display of lesion detection with bounding boxes Fujifilm Co Tokyo Japan
Each eligible patient will undergo a same-day tandem upper gastrointestinal endoscopy performed by the same endoscopist to evaluate the miss rate of gastric neoplasm Patients first receive either AI-assisted or HD upper gastrointestinal endoscopy under white light endoscopy immediately followed by cross-over to other procedure Endoscopists will be assisted by a research assistant RS who activates or deactivates the lesion detection function of AI system between the two examinations Both first and second examinations are conducted in accordance with the systematic gastric screening protocol and only the gastric cavity was rescanned during the second observation The minimal inspection time of the stomach should be 3 minute for the both examination
Biopsies of all targeted lesions will be taken at the end of each examination Endoscopists are instructed to biopsy lesions meeting the following criteria in HD examinations color differences loss of vascularity slight elevation or depression nodularity thickening abnormal convergence or flattening of folds irregular margins irregular discoloration or irregular surface During AI-assisted examinations targeted lesions are defined as focal lesions marked in localization boxes Endoscopists are instructed to biopsy areas stably marked with localization boxes that persisted for 5 seconds by the AI system
Participating endoscopists will receive training on the interpretation of real-time AI detection system as well as detection of dysplasia under HD endoscopy before performing study All patients will fast for at least 6 hours before the procedure All examinations will be performed with HD endoscopes ELUXEO 7000 video system Fujifilm Co Tokyo Japan under white light The artificial intelligence assisted gastric dysplasia localization system uses a graphical user interface for real-time display of lesion detection with bounding boxes Fujifilm Co Tokyo Japan
Each eligible patient will undergo a same-day tandem upper gastrointestinal endoscopy performed by the same endoscopist to evaluate the miss rate of gastric neoplasm Patients first receive either AI-assisted or HD upper gastrointestinal endoscopy under white light endoscopy immediately followed by cross-over to other procedure Endoscopists will be assisted by a research assistant RS who activates or deactivates the lesion detection function of AI system between the two examinations Both first and second examinations are conducted in accordance with the systematic gastric screening protocol and only the gastric cavity was rescanned during the second observation The minimal inspection time of the stomach should be 3 minute for the both examination
Biopsies of all targeted lesions will be taken at the end of each examination Endoscopists are instructed to biopsy lesions meeting the following criteria in HD examinations color differences loss of vascularity slight elevation or depression nodularity thickening abnormal convergence or flattening of folds irregular margins irregular discoloration or irregular surface During AI-assisted examinations targeted lesions are defined as focal lesions marked in localization boxes Endoscopists are instructed to biopsy areas stably marked with localization boxes that persisted for 5 seconds by the AI system
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None