Linked Color Imaging vs White Light Imaging for Detection of Gastric Cancer Precursors

Study Overview
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Brief Summary
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This study aims to examine the use of Linked Color Imaging in detection of gastric cancer precursors, as well as oesophageal and duodenal lesions.

Detailed Description
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Gastric cancer is the fifth most common cause of death worldwide. Early detection and removal of gastric cancer precursors and early gastric cancer is crucial for good outcomes. However, these lesions are subtle and often missed by conventional white light imaging (WLI) endoscopy. Image enhanced endoscopy techniques have been developed to enhance the detection and characterization of gastrointestinal lesions. Narrow band imaging (NBI) is one such technique. Though widely used, its drawbacks include a limited far view as a result of the optical filter causing a dark endoscopic view. Linked color imaging (LCI) is a more recent image enhanced endoscopy technique that acquires images by using both narrow-band wavelength light and white light in an appropriate balance, enhancing slight color differences in the red region of mucosa. It has been proven to improve detection of H pylori gastritis and colorectal neoplasms. Thus far, there has been no study to determine whether the use of LCI will increase the detection rate of gastric cancer precursors and early gastric cancer compared to WLI. This study aims to determine whether LCI can increase the detection rate of gastric cancer precursors and early gastric cancer when compared to white light endoscopy, with the null hypothesis being no difference in detection rates. This study will also examine the use of LCI with magnification to predict histology findings for focal lesions seen on endoscopy, as well as the use of LCI in identifying esophageal lesions (such as Barett's esophagus) and duodenal lesions.

Official Title
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A Prospective Randomized Study of Linked Color Imaging and Conventional White Light Imaging in Gastroscopy for the Detection of Gastric Cancer Precursors

Conditions
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Early Gastric Cancer, Barrett Esophagus

Intervention / Treatment
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* Diagnostic Test: Linked Color Imaging
* Diagnostic Test: White Light Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 50 years and above Patients undergoing gastroscopy for symptom evaluation Patients undergoing gastroscopy for surveillance of known intestinal metaplasia Exclusion Criteria: Emergent gastroscopy performed for suspected acute GI bleeding Patients with previous surgical/endoscopic resection in stomach Patients with deranged coagulation and platelet function (INR>1.5, Plt<50) Patients with severe comorbid illness (ASA 3 and above)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 100 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Linked Color Imaging - White Light Imaging<br>Participant undergoes gastroscopy via Linked Color Imaging first, then followed by White Light Imaging | Diagnostic Test: Linked Color Imaging<br>* Linked Color Imaging (LCI) is a form of image enhanced endoscopy that uses a laser endoscopic system that acquires images by simultaneously using narrow-band wavelength light and white light in an appropriate balance. This enhances slight color differences in the red region of the mucosa.<br>Diagnostic Test: White Light Imaging<br>* White Light Imaging (WLI) uses conventional white light that encompasses all bandwidths of light to illuminate areas of interest to obtain endoscopic images.<br>|
| Other: White Light Imaging - Linked Color Imaging<br>Participant undergoes gastroscopy via White Light Imaging first, then followed by Linked Color Imaging | Diagnostic Test: Linked Color Imaging<br>* Linked Color Imaging (LCI) is a form of image enhanced endoscopy that uses a laser endoscopic system that acquires images by simultaneously using narrow-band wavelength light and white light in an appropriate balance. This enhances slight color differences in the red region of the mucosa.<br>Diagnostic Test: White Light Imaging<br>* White Light Imaging (WLI) uses conventional white light that encompasses all bandwidths of light to illuminate areas of interest to obtain endoscopic images.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in detection rate of gastric lesions between Linked Color Imaging and White Light Imaging | Includes Intestinal Metaplasia, Gastric Adenoma, Low Grade Dysplasia, High Grade Dysplasia, Early Gastric Cancer | Immediately following the procedure | 
| Difference in detection rate of oesophageal lesions between Linked Color Imaging and White Light Imaging | Includes Barrett's Oesophagus, Low Grade Dysplasia, High Grade Dysplasia, Early Oesophageal Cancer | Immediately following the procedure | 
| Difference in detection rate of duodenal lesions between Linked Color Imaging and White Light Imaging | Includes Duodenal adenoma, Duodenal adenocarcinoma | Immediately following the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity of detection of gastric lesions | Includes Intestinal Metaplasia, Gastric Adenoma, Low Grade Dysplasia, High Grade Dysplasia, Early Gastric Cancer | Upon histological confirmation - within 2 weeks of the procedure | 
| Sensitivity and Specificity of detection of oesophageal lesions | Includes Barrett's Oesophagus, Low Grade Dysplasia, High Grade Dysplasia, Early Oesophageal Cancer | Upon histological confirmation - within 2 weeks of the procedure | 
| Sensitivity and Specificity of detection of duodenal lesions | Includes Duodenal adenoma, Duodenal adenocarcinoma | Upon histological confirmation - within 2 weeks of the procedure |