Application of Linked Color Imaging（LCI） in Diagnosis of Early Gastric Cancer(EGC)

Study Overview
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Brief Summary
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the purpose of this study is to evaluate application value of LCI in the diagnosis of early gastric cancer.

Detailed Description
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The detection rate of early gastric cancer is still very low in China. The investigators need a new and effective screening method to improve the detection rate. LCI (linked-color imaging)is a new model of laser endoscopy which can provide brighter image. LCI can provide clear image which can make red part redder and white part whiter, so suspicious lesion could be found easier. The study of this randomized controlled trial is to discuss effectiveness of LCI in the diagnosis of early gastric cancer and to find a new method to improve the detection rate of early gastric cancer in China.

Official Title
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Application of Linked Color Imaging（LCI） in Diagnosis of Early Gastric Cancer(EGC): a Multicenter,Prospective, Randomized Controlled Study

Conditions
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Early Gastric Cancer

Intervention / Treatment
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* Diagnostic Test: LCI+white light


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: High-risk group of gastric cancer: H. pylori infection; previously suffering from chronic atrophic gastritis, intestinal metaplasia, gastric ulcer, gastric polyps, residual stomach after surgery, hypertrophic gastritis, malignant anemia and other precancerous diseases of gastric cancer; First degree relatives of patients with gastric cancer; There are other high risk factors for gastric cancer (high salt, salted diet, smoking, heavy drinking, etc.). Patients with early gastric cancer treated with endoscopic therapy (ESD, EMR). The informed consent has been signed. Exclusion Criteria: The TNM classification of cancer is consistent with those diagnosed by T2 above. Patients with abnormal blood coagulation function or taking anticoagulants can not biopsy. There were contraindications for gastroscopy. A patient without self judgement; Those who did not sign informed consent. Previous gastroscopy has found suspicious lesions requiring careful examination.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 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: Parallel Assignment
Interventional Model Description: Parallel assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LCI+white light<br>Using white light firstly to observe from cardia to duodenum and then switch LCI model to observe from antrum to cardia | Diagnostic Test: LCI+white light<br>* Firstly use white light to observe from cardia to duodenum and then switch LCI model to observe from antrum to cardia<br>|
| No Intervention: White light<br>Using white light only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection rate of gastric neoplastic lesion | Include early gastric caner,high grade dysplasia low grade dysplasia and adenoma | immediately following the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity of detecting gastric neoplastic lesion | Include early gastric caner,high grade dysplasia low grade dysplasia and adenoma | immediately following the procedure | 
| Sensitivity of detecting gastric neoplastic lesion | Include early gastric caner,high grade dysplasia low grade dysplasia and adenoma | immediately following the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Linked-color imaging, Detection