Sensitivity of Targeted Biopsy Within Sydney Protocol for GIM

Intestinal Metaplasia Clinical Trial

Official title:

Sensitivity of Targeted Biopsy Within Sydney Protocol by Using Narrow Band Imaging for Extensive Gastric Intestinal Metaplasia Diagnosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04331951
• Other study ID #: RP016
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: October 31, 2021

Study information

• Verified date: April 2021
• Source: King Chulalongkorn Memorial Hospital
• Contact: Rapat Pittayanon, MD
• Phone: 66804224999
• Email: rapat125[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: October 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intestinal Metaplasia
• Metaplasia

Intervention

Diagnostic Test:
• Targeted 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.

Locations

Country	Name	City	State
Thailand	King Chulalongkorn Memorial Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
King Chulalongkorn Memorial Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.