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Confocal Laser Endomicroscopy vs Conventional Histology for the Identification of Intestinal Metaplasia
Real-time Diagnosis of Barrett's Esophagus: Comparing Confocal Laser Endomicroscopy With Conventional Histology for the Identification of Specialized Intestinal Metaplasia
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
The incidence of esophageal adenocarcinoma has risen over 800% over the past several decades and is associated with a high mortality rate. Barrett's esophagus (BE) has been identified as the number one risk factor for the development of esophageal adenocarcinoma. Gastroesophageal reflux disease (GERD) has been identified as the major risk factor for development of BE. Current guidelines for BE diagnosis and surveillance, according to the Seattle protocol, include four-quadrant random biopsies at 2-cm intervals (1-cm intervals if suspected high grade intraepithelial neoplasia). This random biopsy protocol can be time-consuming, expensive, and prone to sampling error, as very little of the esophageal surface area is actually sampled. Probe-based confocal laser endomicroscopy (pCLE) generates optical biopsies, providing physicians with microscopic images of tissue instantaneously and in a minimally invasive manner. Comparing pCLE with conventional histology for the identification of specialized intestinal metaplasia has the potential to result in a new standard of care for the diagnosis of BE. The aim of this study is to compare pCLE to traditional tissue biopsies for the diagnosis of BE.
A patient with GERD will be scheduled for upper endoscopy as part of routine evaluation. Routine endoscopy will be performed, including white light and narrow band imaging photo documentation. Probe-based confocal laser endomicroscopy will be performed at the gastroesophageal junction. Biopsies of columnar lined esophagus will then be taken in four quadrants starting at the squamocolumnar junction and proceeding in 1 cm segments to the gastroesophageal junction. Optical biopsy images will be reviewed immediately following endoscopy by endoscopist and later reviewed by blinded independent reviewer. Pathology specimens will be reviewed by a pathologist. The results of the optical biopsies obtained with probe-based confocal laser endomicroscopy will be compared with the pathology results.
Studietype
Inschrijving (Werkelijk)
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
- Age >18
- Clinical diagnosis of GERD
- Undergoing upper endoscopy for reflux evaluation
Beschrijving
Inclusion Criteria:
- Age >18; Clinical diagnosis of GERD; Undergoing upper endoscopy for reflux evaluation
Exclusion Criteria:
- Age <18, Contraindication to receiving fluorescein, Inability to provide informed consent, History of esophageal ablation
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Cohort
- Tijdsperspectieven: Prospectief
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Probe-based confocal laser endomicroscopy (pCLE) will be compared to standard histologic analysis in the evaluation of Barrett's esophagus.
Tijdsspanne: 8 months
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Metrics for the study will include "positive" or "negative" for Barrett's esophagus.
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8 months
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Medewerkers en onderzoekers
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CLE-08
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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