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临床试验/NCT04768218
NCT04768218已完成不适用

Blue Light Imaging System for the Diagnosis of Precancerous Conditions: European Multicenter Validation Study

Instituto Portugues de Oncologia, Francisco Gentil, Porto1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
102
试验地点
1
主要终点
To externally validate the EGGIM score classification using BLI

研究概览

简要总结

Introduction: Traditionally, White Light Endoscopy (WLE), enhanced by biopsies following the updated Sydney system guidelines, has been the benchmark for diagnosing and classifying gastric preneoplastic conditions. Nevertheless, the pronounced interobserver variability and the often weak correlation between endoscopic observations and histopathological results have driven the increasing adoption of virtual chromoendoscopy (VCE). VCE technologies have demonstrated greater effectiveness in identifying these conditions compared to WLE, with Narrow Band Imaging (NBI) being particularly notable. Significantly, NBI has played a key role in validating the Endoscopic Grading of Gastric Intestinal Metaplasia (EGGIM) system. However, data on the effectiveness of other VCE technologies in this domain is relatively sparse in Europe, specifically with Blue Light Imaging (BLI), despite the promising diagnostic performance demonstrated with this technology.

Primary aim: to assess the diagnostic accuracy of BLI and to externally validate the applicability of EGGIM classification for staging GIM.

Material and methods: a multicentric cohort study will be performed involving centres from two European countries (Portugal, Italy). Consecutive patients performing upper gastrointestinal 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 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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals older than 18 years.
  • Indication to submit diagnostic or surveillance upper GI endoscopy.

排除标准

  • History of previous gastric surgery.
  • History of previous gastric cancer.
  • Contraindications to biopsies.
  • Individuals unable to give informed consent

结局指标

主要结局

To externally validate the EGGIM score classification using BLI

时间窗: During the 12 months after finishing histopathological analysis of biopsies (an average of 17 months)

For accuracy: A per-patient analysis will be performed comparing WLE and BLI accuracy for Operative Link on Gastritis Assessment for Intestinal Metaplasia (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

To determine the inter-observer agreement and accuracy of BLI system for the diagnosis and endoscopic staging of GIM

时间窗: During the 3 months after finishing histopathological analysis of biopsies (an average of 17 months)

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).

次要结局

未报告次要终点

研究者

发起方
Instituto Portugues de Oncologia, Francisco Gentil, Porto
申办方类型
Other
责任方
Sponsor

研究点 (1)

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