Clinical trial NCT04768218: BLI for the Diagnosis of Precancerous Conditions
Official title: Blue Light Imaging System for the Diagnosis of Precancerous Conditions: European Multicenter Validation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Preneoplastic Condition
Early Gastric Cancer
Lead sponsor: Instituto Portugues de Oncologia, Francisco Gentil, Porto
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: To determine the inter-observer agreement and accuracy of BLI system for the diagnosis and endoscopic staging of GIM
timeFrame: During the 3 months after finishing histopathological analysis of biopsies (an average of 17 months)
measure: To externally validate the EGGIM score classification using BLI
timeFrame: During the 12 months after finishing histopathological analysis of biopsies (an average of 17 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Marta Rodriguez
Study officials:
References: