BLI for the Diagnosis of Precancerous Conditions

NCT04768218 | Completed

• 1 other identifier: 207/020
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer; Preneoplastic Condition; Early Gastric Cancer

Outcome Measures

Primary Outcomes (2)

• 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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Marta Rodriguez

Porto, Portugal

Location

MeSH Terms

Conditions

Stomach Neoplasms; Precancerous Conditions

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 24, 2021
• Study Start: March 1, 2021
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: March 29, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)