Sensitivity of Targeted Biopsy Within Sydney Protocol for GIM

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

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

Study Overview

• Status: Recruiting
• Conditions: Intestinal Metaplasia
• Intervention / Treatment: Diagnostic test: Targeted biopsy within Sydney protocol

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 Type: Interventional
• Enrollment (Anticipated): 105
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rapat Pittayanon, MD; Phone Number: 66804224999; Email: rapat125@gmail.com
• Study Contact Backup: Name: Natee Faknak, MD; Phone Number: 66872006828; Email: F.natee30@gmail.com

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • Recruiting
    • King Chulalongkorn Memorial Hospital
    • Contact: Rapat Pittayanon, MD
    • Contact: Email: rapat125@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: King Chulalongkorn Memorial Hospital
• Investigators: Principal Investigator: Rapat Pittayanon, MD, King Chulalongkorn Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Anticipated): July 31, 2021
• Study Completion (Anticipated): October 31, 2021

Study Registration Dates

• First Submitted: March 31, 2020
• First Submitted That Met QC Criteria: March 31, 2020
• First Posted (Actual): April 2, 2020

Study Record Updates

• Last Update Posted (Actual): April 6, 2021
• Last Update Submitted That Met QC Criteria: April 5, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metaplasia
• Other Study ID Numbers: RP016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No