Sensitivity of Targeted Biopsy Within Sydney Protocol for GIM

NCT ID: NCT04331951

Last Updated: 2021-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2021-10-31

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.

Conditions

Intestinal Metaplasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Targeted biopsy within Sydney protocol

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Chulalongkorn Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Rapat Pittayanon

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rapat Pittayanon, MD

Role: PRINCIPAL_INVESTIGATOR

King Chulalongkorn Memorial Hospital

Locations

King Chulalongkorn Memorial Hospital

Bangkok, , Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Rapat Pittayanon, MD

Role: CONTACT

rapat125@gmail.com

66804224999

Natee Faknak, MD

Role: CONTACT

F.natee30@gmail.com

66872006828

Facility Contacts

Rapat Pittayanon, MD

Role: primary

Role: backup

rapat125@gmail.com

Other Identifiers

RP016

Identifier Type: -

Identifier Source: org_study_id