Sensitivity of Targeted Biopsy Within Sydney Protocol for GIM
1 other identifier
interventional
105
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2019
CompletedFirst Submitted
Initial submission to the registry
March 31, 2020
CompletedFirst Posted
Study publicly available on registry
April 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2021
CompletedApril 6, 2021
April 1, 2021
1.7 years
March 31, 2020
April 5, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (1)
Targeted biopsy within Sydney Protocol
EXPERIMENTALThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- At least 18 year of age
- Suspected GIM by previous tissue pathology
- Able to provide informed consent for participation
You may not qualify if:
- Previous gastric surgery including gastrectomy and bypass surgery
- Coagulopathy
- Pregnancy
- Active upper GI bleeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
King Chulalongkorn Memorial Hospital
Bangkok, 10330, Thailand
Study Officials
- PRINCIPAL INVESTIGATOR
Rapat Pittayanon, MD
King Chulalongkorn Memorial Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- The pathologists will be blinded for the result of endoscopic finding
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
March 31, 2020
First Posted
April 2, 2020
Study Start
November 1, 2019
Primary Completion
July 31, 2021
Study Completion
October 31, 2021
Last Updated
April 6, 2021
Record last verified: 2021-04