BLI for the Diagnosis of Precancerous Conditions and Cancerous Lesions

Study Overview
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Brief Summary
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Introduction: At the present, conventional WLE (white light endoscopy) with biopsies according updated Sydney system is still considered the gold-standard for the diagnosis and stratification of gastric preneoplastic conditions. However, due to the high interobserver variability and the scarce correlation between the endoscopic and histopathological report, there is a growing use of virtual chromoendoscopy, which has shown excellent results on the diagnosis of these conditions. Numerous studies demonstrated the utility of NBI (Narrow Band Imaging) for this purpose, however, there is scarce data regarding the efficacy of the FUJIFILM system, Blue Light Imaging (BLI), on this topic, especially in Europe, despite the good results recently reported. Primary aim: to validate the new high-resolution endoscopic technologies with BLI on the diagnosis of gastric preneoplastic conditions. Material and methods: a multicentric cohort study will be performed involving centres from several European countries (Portugal, Spain, Italy, Belgium, Germany). Consecutive patients performing upper gastrointestinal (GI)endoscopy will be evaluated by WLE and BLI. Random biopsies or targeted plus random biopsies will be performed in order to determine de accuracy of BLI system to detect and stage gastric intestinal metaplasia (GIM). Expected results: We anticipate that BLI would enable us to assess the extension of GIM without the need for biopsies. If observed, this would overall improve the upper GI endoscopy accuracy.

Official Title
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BLI (Blue Light Imaging) System for the Diagnosis of Precancerous Conditions and Cancerous Lesions: European Multicenter Validation Study

Conditions
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Gastric Cancer, Preneoplastic Condition, Early Gastric Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals older than 18 years. Indication to submit diagnostic or surveillance upper GI endoscopy. Exclusion Criteria: History of previous gastric surgery. History of previous gastric cancer. Contraindications to biopsies. Individuals unable to give informed consent

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the inter-observer agreement and accuracy of BLI system for the diagnosis and endoscopic staging of GIM | For accuracy: A per-biopsy analysis will be performed comparing diagnostic perception per site biopsied (ie, accuracy of WLE or BLI for each site observed vs that result). For inter-observer agreement: after following educational set, inter-observer agreement for WLE and BLI will be assessed (see phase 2). | During the 3 months after finishing histopathological analysis of biopsies (an average of 17 months) | 
| To externally validate the EGGIM score classification using BLI | For accuracy: A per-patient analysis will be performed comparing WLE and BLI accuracy for OLGIM III/IV (ie, accuracy of EGGIM estimated by each endoscopist using WLE or BLI towards OLGIM III/IV). For inter-observer agreement: after completion phase 3, video records will be assessed by 1 endoscopist and inter-observer agreement for EGGIM classification, using BLI system, will be evaluated | During the 3 months after finishing histopathological analysis of biopsies (an average of 17 months) |