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Research on real-time diagnosis of superficial esophageal cancer using AI (artificial intelligence) diagnosis system. (Research on real-time diagnosis of esophageal cancer using AI (artificial intelligence).)

Research on real-time diagnosis of esophageal cancer using AI (artificial intelligence).

388

388 patients were enrolled in this study. After enrollment, eight patients were excluded. Of the remaining 380 patients, median age was 72 and 81% (306/380) were male. Finally, a total of 237 detected target lesions were evaluated.

The target lesions were reached in approximately two-thirds of the planned enrollments, as newly detected lesions per case were identified at a higher frequency than originally planned.

No serious adverse event was observed, and only one patient received intravenous flumazenil because of prolonged deep sedation after the endoscopic procedure.

The accuracies of the AI system and endoscopists were 80.6% and 85.7%, respectively. The lower limit of the 90% CI was less than -10%, and we therefore concluded that the non-inferiority of the AI system to endoscopists was not proven. The secondary endpoints of sensitivity, specificity, positive predictive value, and negative predictive value were 68.2%, 83.4%, 48.4%, and 92.0% for the AI system, 61.4%, 91.2%, 61.4%, and 91.2% for the endoscopists, respectively.

The non-inferiority of the AI system to expert endoscopists for real-time diagnosis of ESCC in a clinical setting was not proven.

Dec. 01, 2023

No

No

https://jrct.mhlw.go.jp/latest-detail/jRCTs052200015

Ishihara Ryu

Osaka Prefectural Hospital Organization Osaka International Cancer Institute

3-1-69 Otemae, Chuo-ku, Osaka, 541-8567 Japan

ryu1486@gmail.com

Ishihara Ryu

Osaka Prefectural Hospital Organization Osaka International Cancer Institute

3-1-69 Otemae, Chuo-ku, Osaka, 541-8567 Japan

+81-6-6945-1181

ryu1486@gmail.com

Complete

May. 01, 2020

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

diagnostic purpose

1.Past history of head and neck cancer or esophageal cancer
2.No past history of esophagectomy or esophageal chemotherapy or radiation therapy whose irradiation field involved esophagus
3. from 20 years old to 90 years old
4. No organ failure
5.Written informed consent had been obtained

1.Severe esophageal stricture, which magnifying endoscope can not pass through or which can bleed by passing of endoscope.
2. Antithrombotic medication, which is contraindicated for biopsy in guideline
3. Pregnant women or patients who may be pregnant
4. Inadequate case judged by investigators

Both

Esophageal cancer

Esophageal diagnostic system by artificial intelligence

Esophageal cancer

Accuracy of differential diagnosis for newly detected lesion of esophagus(compared with endoscopists)

1. Sensitivity, specificity, positive predictive value, and negative predictive value of differential diagnosis for newly detected esophageal lesion(compared with endoscopists)
2. Adverse events during or within seven days after endoscopy

+81-6-6945-1181

Mar. 11, 2020

none