NCT04768218Completed
BLI for the Diagnosis of Precancerous Conditions
Blue Light Imaging System for the Diagnosis of Precancerous Conditions: European Multicenter Validation Study
Source: ClinicalTrials.gov · Last updated 29 Mar 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 102 (actual)
- First submitted
- 17 Feb 2021
- Start date
- 1 Mar 2021
- Primary completion date
- 30 Dec 2023
- Lead sponsor
- Instituto Portugues de Oncologia, Francisco Gentil, Porto
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04768218
What you commit to
- Study type: Observational
- Participants enrolled: 102
- From 1 Mar 2021 to the primary completion date, 30 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous gastric surgery.
- History of previous gastric cancer.
Other
- Contraindications to biopsies.
- Individuals unable to give informed consent
Who the study is looking for
- Individuals older than 18 years.
- Indication to submit diagnostic or surveillance upper GI endoscopy.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Marta Rodriguez Coordinator of this site? Confirm its status | Porto | Portugal | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.