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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lesions observed by pCLE | pCLE is used to distinguish the suspected lesions detected by white light endoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The diagnosis of Artificial Intelligence and endoscopist | Diagnostic Test | 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. |
| 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 gastric mucosal disease on real-time pCLE examination. | 24 months |
| 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 gastric mucosal disease on real-time pCLE examination) between Artificial Intelligence and endoscopists. | 24 months |
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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 |
|---|---|---|---|---|---|---|
| Endoscopic unit of Qilu Hospital Shandong University | Jinan | Shandong | 250001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41029674 | Derived | 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. |
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| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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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.