Confocal Laser Endomicroscopy vs Conventional Histology for the Identification of Intestinal Metaplasia

Barrett's Esophagus Clinical Trial

Official title:

Real-time Diagnosis of Barrett's Esophagus: Comparing Confocal Laser Endomicroscopy With Conventional Histology for the Identification of Specialized Intestinal Metaplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02632682
• Other study ID #: CLE-08
• Status: Completed
• Phase: N/A
• First received: December 4, 2015
• Last updated: November 30, 2016
• Start date: February 2016
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: Minnesota Institute for Minimally Invasive Surgery
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Real-time Diagnosis of Barrett's Esophagus: Comparing Confocal Laser Endomicroscopy with Conventional Histology for the Identification of Specialized Intestinal Metaplasia

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus
• Metaplasia

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Minnesota Institute for Minimally Invasive Surgery	The Oregon Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probe-based confocal laser endomicroscopy (pCLE) will be compared to standard histologic analysis in the evaluation of Barrett's esophagus.	Metrics for the study will include "positive" or "negative" for Barrett's esophagus.	8 months	No