Intestinal Metaplasia
Conditions
Brief summary
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
Detailed description
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: * All patients with history of GIM will be enrolled and undergone standard with white light esophagogastroduodenoscopy (EGD). * Those with suspected lesions of GIM will proceed to narrow band imaging (NBI)-mode endoscopy. * Targeted biopsy will be done at the suspected GIM lesions. Random biopsy will be while will be done if no suspicious GIM lesion seen. Data collection: All data will be processed and recorded by one physician.
Interventions
DIAGNOSTIC_TESTTargeted biopsy within Sydney protocol
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.
Sponsors
King Chulalongkorn Memorial Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
The pathologists will be blinded for the result of endoscopic finding
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 year of age * Suspected GIM by previous tissue pathology * Able to provide informed consent for participation
Exclusion criteria
* Previous gastric surgery including gastrectomy and bypass surgery * Coagulopathy * Pregnancy * Active upper GI bleeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of targeted biopsy within Sydney protocol by using narrow band imaging for Extensive Gastric Intestinal Metaplasia diagnosis | 4 weeks after completing the enrollment. | Sensitivity of targeted biopsy within Sydney protocol by using narrow band imaging for Extensive Gastric Intestinal Metaplasia diagnosis |
Countries
Thailand
Contacts
Primary ContactRapat Pittayanon, MD
Backup ContactNatee Faknak, MD
Outcome results
None listed