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Detection and differentiation of esophageal squamous neoplasia (ESN) are of value in improving patient outcomes. Probe-based confocal laser endomicroscopy (pCLE) can diagnose ESN accurately.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| esophageal mucosal lesions observed by pCLE | pCLE is used to distinguish the suspected lesions detected by white light endoscopy or IEE. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The diagnosis of Artificial Intelligence and endoscopist | Diagnostic Test | Suspected esophageal mucosal lesion is observed using pCLE, endoscopist and AI will make a diagnosis independently. In addition, the endoscopist can not see the diagnosis of AI. After a washout period, nonexpert endoscopists take the second assessment with AI assistance. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 esophageal mucosal disease on real-time pCLE examination. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Contrast the diagnosis efficiency of Artificial Intelligence with endoscopists | The secondary outcome is to compare the diagnosis efficiency (including diagnostic accuracy, sensitivity, specificity, PPV, NPV for diagnosing esophageal mucosal disease on real-time pCLE examination) between Artificial Intelligence and endoscopists. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Yanqing Li | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital, Shandong University | Jinan | Shandong | 250001 | China |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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When suspected lesion is found using white light endoscopy , endoscopist will observe this lesion using pCLE and then take biopsy for histology examination.
|
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |