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| Name | Class |
|---|---|
| Wuxi Hisky Medical Technology Co Ltd | INDUSTRY |
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This study is A prospective, randomized, multicenter clinical trial: The study intends to include subjects suspected of early gastric cancer, including 378 subjects with neoplastic lesions and 200 subjects with non-neoplastic lesions. The subjects are divided into two groups by random envelopes, A and B, and the endoscopic diagnosis in different groups is performed in different order (including: White light endoscopy,CellTouch, Magnifying endoscopy with NBI(ME-NBI)). Finally, the gold standard of histopathology was used to evaluate the diagnostic performance of CellTouch in the diagnosis of early gastric cancer.The study hypothesized that the sensitivity and specificity of CellTouch in the diagnosis of early gastric cancer could reach more than 90% and more than 95%.
Objectives:
1. Histopathology was used as the gold standard to evaluate the diagnostic performance of CellTouch in the diagnosis of early gastric cancer.
Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A group | The sequence of endoscopy in group A was as follows: white light endoscopy, ME-NBI endoscopy,Confocal laser endomicroscopy. | ||
| B group | The sequence of endoscopy in group B was as follows: white light endoscopy, Confocal laser endomicroscopy, ME-NBI endoscopy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Histopathology was used as the diagnostic gold standard to evaluate the diagnostic performance of CellTouch in the diagnosis of early gastric cancer. | The diagnostic properties of CellTouch include: sensitivity and specificity. | 30 min |
| Measure | Description | Time Frame |
|---|---|---|
| Using histopathology as the diagnostic gold standard, the diagnostic performance of CellTouch and ME-NBI in early gastric cancer was compared and analyzed. | Diagnostic performance related indexes include: accuracy, sensitivity, specificity, positive predictive value, negative predictive value. | 30 min |
| Using histopathology as the diagnostic gold standard, the diagnostic performance of CellTouch combined with ME-NBI and ME-NBI alone in early gastric cancer was compared and analyzed. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have recently found suspicious lesions by gastroscopy and need further intensive examination;(Suspicious lesions refer to suspected superficial neoplastic lesions visible under white light endoscopy, including elevation type, flatness type and depression type. According to the Paris classification standard).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| wei an, doctor | Contact | 13621719085 | anweisusan@163.com |
| Name | Affiliation | Role |
|---|---|---|
| zhen-dong jin, phD | Changhai Hospital shanghai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Shanghai | Shanghai Municipality | 210000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35243116 | Background | Pilonis ND, Januszewicz W, di Pietro M. Confocal laser endomicroscopy in gastro-intestinal endoscopy: technical aspects and clinical applications. Transl Gastroenterol Hepatol. 2022 Jan 25;7:7. doi: 10.21037/tgh.2020.04.02. eCollection 2022. | |
| 36765734 | Background | Han W, Kong R, Wang N, Bao W, Mao X, Lu J. Confocal Laser Endomicroscopy for Detection of Early Upper Gastrointestinal Cancer. Cancers (Basel). 2023 Jan 26;15(3):776. doi: 10.3390/cancers15030776. |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Diagnostic performance related indexes include: accuracy, sensitivity, specificity, positive predictive value, negative predictive value. |
| 30 min |
| Using histopathology as the diagnostic gold standard, the diagnostic performance of CellTouch and ME-NBI in the differential diagnosis of low-grade intraepithelial neoplasia and high-grade intraepithelial neoplasia was evaluated. | Diagnostic performance related indexes include: accuracy, sensitivity, specificity, positive predictive value, negative predictive value. | 30 min |
| 35173829 | Background | Zhou YW, Zhang LY, Ding SN, Zhang AL, Zhu Y, Chen YX, Zhang QC, Sun LT, Yu JR. Hesitate between confocal laser endomicroscopy and narrow-band imaging: how to choose a better method in the detection of focal precancerous state of gastric cancer. Am J Transl Res. 2022 Jan 15;14(1):55-67. eCollection 2022. |
| 35402229 | Background | Pang S, Yao H, Jiang C, Zhang Q, Lin R. Confocal Laser Endomicroscopy Can Improve the Diagnosis Rate and Range Assessment of Patients With Conflicting Chronic Atrophic Gastritis Results of White Light Endoscopic and Pathological Diagnosis. Front Oncol. 2022 Mar 24;12:809822. doi: 10.3389/fonc.2022.809822. eCollection 2022. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |