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Sensitivity of Targeted Biopsy Within Sydney Protocol by Using Narrow Band Imaging for Extensive Gastric Intestinal Metaplasia Diagnosis
Objective:
The aim of this study is to evaluate the sensitivity of targeted biopsy within Sydney protocol by using narrow band imaging for Extensive Gastric Intestinal Metaplasia diagnosis
Research design: Diagnosis study
Sample size: 105 cases
Data analysis:
The outcomes will be presented using 2 by 2 tables and if the data are normal distribution the categorical data will be analysed using McNemar's test
Background and Rationale:
Gastric cancer has been in the top-5 of cancer-related death worldwide. Early detection by screening program in high risk patients is very important. If we can detect pre-malignant lesion eg. gastric intestinal metaplasia, we can provide the appropriate surveillance program to those patients. However, the screening protocol for gastric intestinal metaplasia remained unclear. Recently in July 2019, British Society of Gastroenterology published the guideline on the diagnosis and management of patients at risk of gastric adenocarcinoma. The image-enhanced endoscopy (IEE) is recommended as the best modality for assessing gastric intestinal metaplasia. Additionally, they recommended taking biopsy by using Sydney protocol which means taking biopsy at two areas for antrum, two areas for body and one for incisura although they look normal. We aimed to evaluate the sensitivity of this protocol for extensive gastric intestinal metaplasia (GIM) diagnosis in this study.
Methodology:
Data collection:
All data will be processed and recorded by one physician.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Targeted biopsy within Sydney Protocol | Experimental | The patients with history of gastric intestinal metaplasia will be included and using targeted biopsy within Sydney Protocol; both targeted biopsy at suspicious lesions and random biopsy at no suspicious area.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Targeted biopsy within Sydney protocol | Diagnostic Test | Biopsy at suspicious GIM lesions at any area of antrum (both lesser and greater curvature site), body (both lesser and greater curvature site) and incisura. If there is no abnormal mucosa seen at any site, random biopsy will be performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of targeted biopsy within Sydney protocol by using narrow band imaging for Extensive Gastric Intestinal Metaplasia diagnosis | Sensitivity of targeted biopsy within Sydney protocol by using narrow band imaging for Extensive Gastric Intestinal Metaplasia diagnosis | 4 weeks after completing the enrollment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rapat Pittayanon, MD | Contact | 66804224999 | rapat125@gmail.com | |
| Natee Faknak, MD | Contact | 66872006828 | F.natee30@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Rapat Pittayanon, MD | King Chulalongkorn Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Chulalongkorn Memorial Hospital | Recruiting | Bangkok | 10330 | Thailand |
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The pathologists will be blinded for the result of endoscopic finding
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