Sensitivity of Targeted Biopsy Within Sydney Protocol for GIM

Status Recruiting

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04331951
Study type	Interventional
Source	King Chulalongkorn Memorial Hospital
Contact	Rapat Pittayanon, MD
Phone	66804224999
Email	rapat125@gmail.com
Status	Recruiting
Phase	N/A
Start date	November 1, 2019
Completion date	October 31, 2021

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.