The Diagnostic Ability of White Light Endoscopy and Magnifying Endoscopy With Optical Enhancement System

Study Overview
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Brief Summary
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The purpose of this study is to valuation of the diagnostic ability of white light imaging and magnifying endoscopy with optical enhancement system in early gastric cancer and intraepithelial neoplasia.

Detailed Description
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Stomach cancer is the second most common cause of cancer death. Endoscopic identification and treatment of gastric intestinal metaplasia (GIM) and early gastric cancer (EGC) is essential to improve patients' 5-year survival rates. Conventional endoscopy with white light imaging (WLI) is widely used for endoscopic evaluation of EGCs. However, conventional endoscopic visualization of EGCs has a high rate of interobserver variability and correlates poorly with the histological findings. For this reason, diagnosis has been based mostly on repeated endoscopy with multiple biopsy samples. It has been reported that optical enhancement (OE) system is useful for discriminating cancerous lesions from non-cancerous lesions. The OE system is the newly developed image-enhanced endoscopic technology, which combines high definition white light endoscopy (WLE) and optical filters that limit the spectral characteristics of the illumination light. The optical filters can achieve higher overall transmittance by connecting the peaks of the hemoglobin absorption spectrum creating a continuous wavelength spectrum. Magnifying endoscopy is useful for observing the mucosal structures and microvessels. The VS theory proposed by Yao K is widely used in Magnifying endoscopy with optical enhancement system (ME-OE). Based on technical considerations, it is conceivable that ME-OE imaging techniques might have a distinct advantage over WLE in the diagnosis of endoscopic lesions. However, few reports have objectively proved that ME-OE is superior to WLE in the detection rate and diagnostic efficiency of EGCs.

Official Title
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Evaluation of the Diagnostic Ability of White Light Endoscopy and Magnifying Endoscopy With Optical Enhancement System in Early Gastric Cancer and Intraepithelial Neoplasia: a Prospective Randomized Controlled Trial

Conditions
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Early Gastric Cancer

Intervention / Treatment
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* Device: magnifying endoscopy with optical enhancement system
* Device: white light endoscopy system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18-80 years with H. pylori infection or histologically verified gastric lesions (chronic atrophic gastritis, intestinal metaplasia, GIN or EGC) Or patients aged 40-80 years from a region with high incidence of gastric cancer Or patients aged 40-80 years with first-degree relative of patients with gastric cancer Or patients aged 40-80 years with high-risk factors for gastric cancer (high salt or pickle diet or smoking or heavy drinking) Exclusion Criteria: A history of gastrectomy Active gastrointestinal bleeding or advanced gastric carcinoma Coagulopathy or severe underlying diseases Pregnancy or lactation Absence of informed consent

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnifying endoscopy with optical enhancement system group<br>Patients in this group go through gastroscopy under the magnifying endoscopy with optical enhancement system. | Device: magnifying endoscopy with optical enhancement system<br>* A complete screening examination was first performed with white light endoscopy. Additionally, the types of endoscopic GIN and EGC were recorded according to the Paris Classification. After visualization in white light mode, the stomach was reinspected by using OE mode2. Then, in vivo diagnoses of lesions were made by using OE mode1 according to VS theory. For all suspicious areas, a minimum of one biopsy specimens were first taken in a targeted fashion.<br>|
| Active Comparator: white light endoscopy group<br>Patients in this group go through gastroscopy under white light endoscopy. | Device: white light endoscopy system<br>* A complete screening examination was first performed with white light endoscopy. Additionally, the types of endoscopic GIN and EGC were recorded according to the Paris Classification. For all suspicious areas, a minimum of one biopsy specimens were first taken in a targeted fashion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detection rate of GIN and EGC | The primary outcome was the detection rate of gastric intestinal metaplasia (GIM) and early gastric cancer (EGC) in a per-patient analysis. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity, specificity of diagnostic performances of GIN and EGC |  | 3 months | 
| positive predictive value of diagnostic performances of GIN and EGC |  | 3 months | 
| negative predictive value of diagnostic performances of GIN and EGC |  | 3 months | 
| diagnostic accuracy in a per-biopsy analysis |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early gastric cancer, Optical enhancement system