Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT04768218
Status:
COMPLETED
Last Update Posted:
2024-03-29
First Post:
2021-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BLI for the Diagnosis of Precancerous Conditions
Sponsor:
Instituto Portugues de Oncologia, Francisco Gentil, Porto
Organization:
Study Overview
Official Title:
Blue Light Imaging System for the Diagnosis of Precancerous Conditions: European Multicenter Validation Study
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: