BLI for the Diagnosis of Precancerous Conditions

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

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.

Study Overview

• Status: Completed
• Conditions: Early Gastric Cancer; Gastric Cancer; Preneoplastic Condition

• Study Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• Portugal
  • Porto, Portugal
    • Marta Rodriguez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients referred to the endoscopy department of a tertiary care center for screening or surveillance upper gastrointestinal endoscopy.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Instituto Portugues de Oncologia, Francisco Gentil, Porto

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: February 17, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 24, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Disease; Precancerous Conditions
• Other Study ID Numbers: 207/020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No