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The purpose of this study is to assess whether confocal laser endomicroscopy can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield.
Gastric intestinal metaplasia is a well-known premalignant lesions for intestinal type gastric cancer. However, present guidelines such as the updated Sydney System require multiple biopsies whereas reveal an unsatisfactory yield considering the detection and surveillance of these lesions. Confocal laser endomicroscopy is a newly developed endoscopic device that enables microscopic view of the digestive tract. Previous study has showed high sensitivity and specificity for in vivo diagnosis of gastric intestinal metaplasia using confocal laser endomicroscopy. This study aims to assess the real number of biopsies that can be reduced for the detection of gastric intestinal metaplasia using confocal laser endomicroscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | confocal laser endomicroscopy |
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| 2 | Active Comparator | standard endoscopy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endomicroscope | Device | Pentax EC3870K, Tokyo, Japan |
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| Measure | Description | Time Frame |
|---|---|---|
| the diagnostic yield of gastric intestinal metaplasia | Seven months |
| Measure | Description | Time Frame |
|---|---|---|
| the biopsy number needed in each group | Seven months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanqing Li, PhD. MD. | Department of Gastroenterology, Qilu Hospital, Shandong University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology, Qilu Hospital, Shandong University | Jinan | Shandong | 250012 | China |
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| Standard endoscopy | Device | Pentax EG-2931 gastroscope |
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