NCT04040374

Artificial Intelligence Versus Expert Endoscopists for Diagnosis of Gastric Cancer

A Single-center, Retrospective, Open Label, Randomized Controlled Trial of Artificial Intelligence Versus Expert Endoscopists for Diagnosis of Gastric Cancer in Patients Who Underwent Upper Gastrointestinal Endoscopy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Tokyo University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Title: A single-center, retrospective randomized controlled trial of artificial intelligence (AI) versus expert endoscopists for diagnosis of gastric cancer in patients who underwent upper gastrointestinal endoscopy. Précis: this single-center, retrospective randomized controlled trial will include 500 outpatients who underwent upper gastrointestinal endoscopy for gastric cancer screening and will compare the diagnostic detection rate for gastric cancer of AI and expert endoscopists. Objectives Primary Objective: to evaluate the diagnostic detection rate for gastric cancer of AI and expert endoscopists. Secondary Objectives: to determine whether AI is not inferior to expert endoscopists in terms of the number of images analyzed for diagnosis of gastric cancer and intersection over union (IOU), and the detection rate of diagnosis of early and advanced gastric cancer. Endpoints Primary Endpoint: diagnosis of gastric cancer. Secondary Endpoints: image based diagnosis of gastric cancer and IOU. Population: in total, 500 males and females aged ≥ 20 years who underwent upper gastrointestinal endoscopy for screening of gastric cancer at a single hospital in Japan. Describe the Intervention: AI-based diagnosis of gastric cancer based on upper gastrointestinal endoscopy images. Study Duration: 3 months.

Detailed description

Prior to Study: Total 500: Screen potential subjects by inclusion and exclusion criteria; obtain endoscopy images. Randomization was performed. Intervention: AI diagnosis was performed for 250 patients using upper gastrointestinal endoscopy images, and Expert endoscopists diagnosis was performed for 250 patients by same methods. Primary analysis: Perform primary analysis of primary and secondary endpoints for 250 patients in each group Cross over diagnosis between AI and expert endoscopists was performed. Perform secondary analysis of agreement of gastric cancer diagnosis per images and IOU between AI and expert endoscopists for 500 patients.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	AI-based diagnosis	AI-based diagnosis will be performed based on analysis of endoscopic images (Olympus Optical, Tokyo, Japan). The investigators will use the Single Shot MultiBox Detector (SSD), a deep neural network architecture (https://arxiv.org/abs/1512.02325), and an optimal diagnostic cutoff from a prior report2. The AI system reviewed endoscopy images and reported those in which gastric cancer was detected, together with the coordinates (X, Y) of the lesions.
DIAGNOSTIC_TEST	The expert endoscopists-based diagnosis	The expert endoscopists are two physicians with experience of more than 20,000 endoscopies. The expert endoscopists will review the endoscopy images of each patient for 5 min. They will then report endoscopy images in which gastric cancer was detected and manually annotate the lesions in those images.

Timeline

• Start date: 2019-07-01
• Primary completion: 2019-10-01
• Completion: 2019-11-16
• First posted: 2019-07-31
• Last updated: 2019-11-20

Locations

1 site across 1 country: Japan