I-scan With Magnification for the Detection of Gastric Intestinal Metaplasia

Study Overview
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Brief Summary
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The purpose of this study is to assess whether i-scan with magnification can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield.

Detailed Description
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Gastric intestinal metaplasia is regarded as an important premalignant lesion for intestinal type gastric cancer. Currently, the histological assessment of gastric intestinal metaplasia still relies on the biopsies took from five sites that the updated Sydney System recommended. However, the updated Sydney System biopsy protocol needs more biopsy number and procedure time, for it is unable to satisfy the diagnosis of gastric intestinal metaplasia. I-scan is a novel image-enhanced endoscopy system based on the post processing of reflected light without optical filters. Targeted biopsy protocol based on i-scan with magnification will be possible for the diagnosis of gastric intestinal metaplasia. This study aims to compare the diagnostic yield of gastric intestinal metaplasia from i-scan with magnification targeted biopsies and a standard biopsy protocol and assess whether i-scan with magnification can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield.

Official Title
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I-scan With Magnification Targeted Biopsies Compared With a Standard Biopsy Protocol for the Detection of Gastric Intestinal Metaplasia in a High Risk Population: a Randomized Controlled Trial

Conditions
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Gastric Intestinal Metaplasia

Intervention / Treatment
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* Device: I-scan with magnification
* Device: Standard endoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with dyspeptic symptoms and aged 40 years or older or patients with Helicobacter pylori infection, or histologically verified gastric intestinal metaplasia or atrophic gastritis or patients with family history of gastric cancer Exclusion Criteria: presence of gastrectomy, acute gastrointestinal bleeding, or known gastric neoplasia presence of conditions unsuitable for endoscopy procedure including coagulopathy, impaired cardiopulmonary function , pregnancy or breastfeeding inability to provide informed consent

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>I-scan with magnification targeted biopsies for gastric intestinal metapalsia. | Device: I-scan with magnification<br> <br> |
| Active Comparator: Group 2<br>Standard endoscopy with a standard biopsy protocol from the five standard biopsy sites following the updated Sydney System including two from the distal antrum (within 2-3cm from the pylorus, greater/lesser curvature), one from the incisura and two from the mid corpus (greater/lesser curvature). | Device: Standard endoscopy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of the detection rate of gastric intestinal metaplasia between i-scan with magnification targeted biopsies and standard endoscopy with standard biopsy protocol in a per-pateint analysis |  | seven months | 
| Difference of the detection rate of gastric intestinal metaplasia between i-scan with magnification targeted biopsies and standard endoscopy with standard biopsy protocol in a per-biopsy analysis |  | seven months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of biopsies needed in per group |  | seven months |