Sensitivity of Targeted Biopsy Within Sydney Protocol for GIM

Not Applicable

• Conditions: Intestinal Metaplasia
• Interventions: Diagnostic Test: Targeted biopsy within Sydney protocol

• Registration Number: NCT04331951
• Lead Sponsor: King Chulalongkorn Memorial Hospital

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.

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2020-03-31
• Study First Submitted QC: 2020-03-31
• Study First Posted: 2020-04-02
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-05
• Last Update Posted: 2021-04-06
• Primary Completion: 2021-07-31
• Study Completion: 2021-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Targeted biopsy within Sydney Protocol	Targeted biopsy within Sydney protocol	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. * All tissues will be sent to immunohistochemistry as a gold standard. * Sensitivity, specificity,positive predictive value, negative predictive value, accuracy will be calculated.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

King Chulalongkorn Memorial Hospital; 🇹🇭 Bangkok, Thailand