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Clinical Trials/NCT05819099
NCT05819099Not yet recruitingNot Applicable

The Role of Artificial Intelligence in Endoscopic Diagnosis of Esophagogastric Junctional Adenocarcinoma:A Single Center, Case-control, Diagnostic Study

Qilu Hospital of Shandong University0 sites200 target enrollmentStarted: December 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
200
Primary Endpoint
Specificity

Study Overview

Brief Summary

This is a single center, case-control, diagnostic study.The aim of this study is to use deep learning methods to retrospectively analyze the imaging data of gastrointestinal endoscopy in Qilu Hospital, and construct an artificial intelligence model based on endoscopic images for detecting and determining the depth of invasion of esophagogastric junctional adenocarcinoma.This study will also compare the established AI model with the diagnostic results of endoscopists to evaluate the clinical auxiliary value of the model for endoscopists.The research includes stages such as data collection and preprocessing, artificial intelligence model development, model testing and evaluation. The gastroscopy image dataset constructed by this research institute mainly includes three modes of endoscopic imaging: white light endoscopy, optical enhancement endoscopy (OE), and narrowband imaging endoscopy (NBI).

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • This study included endoscopic images of patients aged 18 and above who underwent endoscopic examination or treatment
  • All patients in the case group need to be pathologically confirmed as esophageal gastric junction adenocarcinoma, and a pathologist has conducted a standardized pathological evaluation of the tumor classification of the lesion, including the overall appearance, size, differentiation type, depth of infiltration, presence or absence of lymphatic/vascular invasion, surgical margin status, etc.
  • The endoscopic images of the control group patients need to be confirmed by biopsy pathology or at least two experienced endoscopists (with operating experience>5000 cases) to jointly confirm that they have clear benign manifestations

Exclusion Criteria

  • The patient has a previous history of endoscopic treatment or surgery for the esophageal gastric junction.
  • Necessary clinical information cannot be provided during the research process (patient age, gender, lesion characteristics, endoscopic manifestations, endoscopic images, etc.)
  • Low quality endoscopic images, such as those severely affected by bleeding, aperture, blurring, defocusing, artifacts, or excessive mucus after biopsy.

Outcomes

Primary Outcomes

Specificity

Time Frame: 36 months

The researchers calculated the specificity of the established AI model and compared it with endoscopists of different levels.

Positive predictive value

Time Frame: 36 months

The researchers calculated the positive predictive value of the established AI model and compared it with endoscopists of different levels.

Sensitivity

Time Frame: 36 months

The researchers calculated the sensitivity of the established AI model and compared it with endoscopists of different levels.

Accuracy

Time Frame: 36 months

The researchers calculated accuracy positive predictive value of the established AI model and compared it with endoscopists of different levels.

Negative predictive value

Time Frame: 36 months

The researchers calculated the negative predictive value of the established AI model and compared it with endoscopists of different levels.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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