NCT03784209|Completed
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Sponsor study identifier
observational
951
1 country
1
Study Start
July 1, 2018
Actual (reported)Primary Completion
September 29, 2021
Actual (reported)Study Completion
September 29, 2021
Actual (reported)Probe-based confocal laser endomicroscopy (pCLE) is an endoscopic technique that enables real-time histological evaluation of gastric mucosal disease during ongoing endoscopy examination. However this requires much experience, which limits the application of pCLE. The investigators designed a computer-aided diagnosis program using deep neural network to make diagnosis automatically in pCLE examination and contrast its performance with endoscopists.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 29, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 1, 2018
Actual (reported)December 16, 2018
Actual (reported)December 21, 2018
Actual (reported)September 29, 2021
Actual (reported)September 29, 2021
Actual (reported)The diagnosis efficiency of Artificial Intelligence
The primary outcome is to test the diagnostic accuracy, sensitivity, specificity, PPV, NPV of the Artificial Intelligence for diagnosing gastric mucosal disease on real-time pCLE examination.
24 months
Contrast the diagnosis efficiency of Artificial Intelligence with endoscopists
24 months
pCLE is used to distinguish the suspected lesions detected by white light endoscopy.
When suspected lesion is observed using pCLE, endoscopist and AI will make a diagnosis independently. In addition, the endoscopist can not see the diagnosis of AI.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Consecutive patients who receive the upper gastrointestinal tract pCLE examination and screened that fulfill the eligibility criteria at Qilu Hospital, Shandong University will be enrolled into the study
Endoscopic unit of Qilu Hospital Shandong University
Jinan, Shandong, 250001, China
Liu G, Li G, Li Z, Shao X, Ji R, Ma T, Zhang Y, Su J, Qi Q, Guo J, He Y, Yang X, Li Y, Zuo X. Deep learning-aided optical biopsy achieves whole-chain diagnosis of Correa cascade of gastric cancer: a prospective study. BMC Med. 2025 Sep 30;23(1):527. doi: 10.1186/s12916-025-04310-9.
When a gastric mucosal lesion is found using white light endoscopy , endoscopist will observe this lesion using pCLE and then take biopsy for histology examination.
Yanqing Li
Qilu Hospital of Shandong University
951 participants (actual enrollment reported by the registry).
First Submitted
December 16, 2018
First Posted
December 21, 2018
Study Start
July 1, 2018
Actual (reported)Artificial Intelligence for Early Diagnosis of Esophageal Squamous Cell Carcinoma
Contact the study team to confirm eligibility.
Primary Completion
September 29, 2021
Actual (reported)Study Completion
September 29, 2021
Actual (reported)Last Updated
April 1, 2022
Record last verified: 2022-03
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Source: ClinicalTrials.gov.
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