Study on the usefulness of AI for diagnosis of gastric cancer

JRCT ID: jRCTs032210171

Registered date:29/06/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: early gastric cancer, gastric adenoma
• Date of first enrollment: 29/06/2021
• Target sample size: 310
• Study type: Interventional
• Intervention(s): Endoscopic observation of the stomach during esophagogastroduodenoscopy is performed under the AI-assisted system.

Outcome(s)

• Primary Outcome: Accuracy rate of diagnosis for superficial gastric neoplasm in non-specialists of endoscopy under the AI-assisted system

Secondary Outcome

1) Sensitivity, specificity, positive predictive value, and negative predictive value of diagnosis for superficial gastric neoplasm in non-specialists of endoscopy under the AI-assisted system
2) Sensitivity, specificity, accuracy rate, positive predictive value, and negative predictive value of diagnosis for superficial gastric neoplasm in specialists of endoscopy under the AI-assisted system
3) The number of biopsies
4) Observation time for stomach
5) Probability of AI-system diagnosing superficial gastric neoplasm

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients who will receive esophagogastroduodenoscopy.
2) Aged 20 years and older on the date of consent.
3) ECOG-PS: 0-1.
4) Patients who have given written consent voluntarily to participate in this study.

Exclude criteria

1) Patients with past history of gastrectomy.
2) Patients with bleeding tendency.
3) Patients who take two or more antithrombotic drugs and cannot withdraw antithrombotic drugs for biopsy according to the guideline.
4) Women who are pregnant, possibly pregnant.
5) Patients deemed inappropriate by the investigator.

Related Information

• Primary Sponsor: Higuchi Kazutoshi
• Source(s) of Monetary Support: AI Medical Service Inc.