BLI for the Diagnosis of Precancerous Conditions

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04768218
• Other study ID #: 207/020
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: December 2023
• Source: Instituto Portugues de Oncologia, Francisco Gentil, Porto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Early Gastric Cancer
• Gastric Cancer
• Precancerous Conditions
• Preneoplastic Condition
• Stomach Neoplasms

Locations

Country	Name	City	State
Portugal	Marta Rodriguez	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Portugues de Oncologia, Francisco Gentil, Porto

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)