Clinical trial NCT05819099: The Role of Artificial Intelligence in Endoscopic Diagnosis of Esophagogastric Junctional Adenocarcinoma：A Single Center, Case-control, Diagnostic Study
Official title: The Role of Artificial Intelligence in Endoscopic Diagnosis of Esophagogastric Junctional Adenocarcinoma：A Single Center, Case-control, Diagnostic Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stomach Neoplasms
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study included endoscopic images of the esophageal gastric junction retrieved from the Endoscopy Center of Qilu Hospital for training and testing the model.The study population underwent pathological examination and the pathological results were used as the gold standard.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity
timeFrame: 36 months
measure: Specificity
timeFrame: 36 months
measure: Negative predictive value
timeFrame: 36 months
measure: Positive predictive value
timeFrame: 36 months
measure: Accuracy
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
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Study officials:
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