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The purpose of this study is to assess whether high definition endoscopy with Optic Enhancement 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 regarded as an important premalignant lesion for intestinal type gastric cancer. Currently, the histological assessment of gastric intestinal metaplasia still relies on the biopsies took from five sites that the updated Sydney System recommended. However, the updated Sydney System biopsy protocol needs more biopsy number and procedure time, for it is unable to satisfy the diagnosis of gastric intestinal metaplasia. Optic Enhancement is a novel image-enhanced endoscopy system. Targeted biopsy protocol based on high definition endoscopy with Optic Enhancement will be possible for the diagnosis of gastric intestinal metaplasia. This study aims to compare the diagnostic yield of gastric intestinal metaplasia from high definition endoscopy with Optic Enhancement targeted biopsies and a standard biopsy protocol and assess whether high definition endoscopy with Optic Enhancement can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Standard endoscopy with a standard biopsy protocol from the five standard biopsy sites following the updated Sydney System including two from the distal antrum (within 2-3cm from the pylorus, greater/lesser curvature), one from the incisura and two from the mid corpus (greater/lesser curvature). |
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| Group 2 | Experimental | High definition endoscopy with Optic Enhancement targeted biopsies for gastric intestinal metaplasia. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard endoscopy | Device |
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| High definition endoscopy with Optic Enhancement |
| Measure | Description | Time Frame |
|---|---|---|
| Difference of the detection rate of gastric intestinal metaplasia between high definition endoscopy with Optic Enhancement targeted biopsies and standard endoscopy with standard biopsy protocol in a per-patient analysis | eight months | |
| Difference of the detection rate of gastric intestinal metaplasia between high definition endoscopy with Optic Enhancement targeted biopsies and standard endoscopy with standard biopsy protocol in a per-biopsy analysis | eight months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of biopsies needed in per group | eight months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanqing Li, PhD. MD. | Contact | 18678827666 | qiluliyanqing@gmail.com |
| 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 | Recruiting | Jinan | Shandong | 250012 | China |
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