Linked Color Imaging Based CMV Diagnosis for Gastric Mucosal Lesions

Study Overview
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Brief Summary
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The newly developed linked color imaging (LCI) system (FUJIFILM Co.) creates clear and bright endoscopic images by using short-wavelength narrow-band laser light combined with white laser light on the basis of BLI technology. This system can obtain bright endoscopic images even at a distant view because LCI has more intense white light than the short-wavelength narrow-band laser light. Short-wavelength narrow-band laser light enhances the vessels on the mucosal surface and the patterns of the mucosa. Therefore, LCI may facilitate the detection of gastric mucosal lesions. Further studies are needed to confirm the clinical utility of LCI.

Detailed Description
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LCI enhances differences in hue, in the red region of the spectrum, through digital processing. This makes red areas appear redder and white areas appear whiter. Thus, it is easier to recognize a slight difference in color of the mucosa. Based on previous experience, a new LCI based endoscopic diagnosis criteria called CMV (color- microstructure-vessel) criteria has been proposed, which could be used for judging the gastric mucosal lesions. LCI has the advantage of detecting color changes of the mucosa, and this could provide very valuable and useful evidence for making endoscopic diagnosis. In this study, a blinded random controlled clinical trial is designed to further validate the diagnostic value of LCI based CMV criteria for gastric diseases.

Official Title
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CMV Criteria in the Detection of Gastric Diseases Using Linked Color Imaging

Conditions
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Gastric Disease

Intervention / Treatment
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* Procedure: WLE and then LCI
* Procedure: LCI and then WLE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Above 18 years old patients Who agree to participate in the study Patients with the indications for gastroduodenoscopy Exclusion Criteria: Patients, who were receiving nonsteroidal anti-inflammatory drugs, pump inhibitors (PPI) or antibiotics in the last 3 weeks. Severe uncontrolled coagulopathy Prior history of gastric surgery. Pregnancy and lactation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Patients with indications for gastroduodenoscopy will be evaluated with WLE and then LCI. | Procedure: WLE and then LCI<br>* The gastric mucosa was evaluated with WLE and then LCI by two different endoscopists.<br>|
| Experimental: Group B<br>Patients with indications for gastroduodenoscopy will be evaluated with LCI and then WLE. | Procedure: LCI and then WLE<br>* The gastric mucosa was evaluated with LCI and then WLE by two different endoscopists.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy | Diagnostic accuracy of LCI for gastric diseases was calculated by comparing the LCI endoscopic diagnosis with pathological diagnosis. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers of lesions in the stomach | The numbers of lesion detected under WLE and LCI will be recorded and compared. | 4 months | 
| Endoscopic examination duration | The time spent on the endoscopic examination using WLE and LCI will be compared. | 4 months |