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Sensitivity of Targeted Biopsy Within Sydney Protocol for GIM

Primary Purpose

Intestinal Metaplasia

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Targeted biopsy within Sydney protocol
Sponsored by
King Chulalongkorn Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Intestinal Metaplasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • King Chulalongkorn Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Targeted biopsy within Sydney Protocol

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 31, 2020
Last Updated
April 5, 2021
Sponsor
King Chulalongkorn Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04331951
Brief Title
Sensitivity of Targeted Biopsy Within Sydney Protocol for GIM
Official Title
Sensitivity of Targeted Biopsy Within Sydney Protocol by Using Narrow Band Imaging for Extensive Gastric Intestinal Metaplasia Diagnosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
October 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Chulalongkorn Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Metaplasia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
The pathologists will be blinded for the result of endoscopic finding
Allocation
N/A
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Targeted biopsy within Sydney Protocol
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Targeted biopsy within Sydney protocol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sensitivity of targeted biopsy within Sydney protocol by using narrow band imaging for Extensive Gastric Intestinal Metaplasia diagnosis
Description
Sensitivity of targeted biopsy within Sydney protocol by using narrow band imaging for Extensive Gastric Intestinal Metaplasia diagnosis
Time Frame
4 weeks after completing the enrollment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rapat Pittayanon, MD
Phone
66804224999
Email
rapat125@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Natee Faknak, MD
Phone
66872006828
Email
F.natee30@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rapat Pittayanon, MD
Organizational Affiliation
King Chulalongkorn Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rapat Pittayanon, MD
Email
rapat125@gmail.com

12. IPD Sharing Statement

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Sensitivity of Targeted Biopsy Within Sydney Protocol for GIM

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