Endoscopic Tri-Modal Imaging in Patients With Barrett's Esophagus — ETMI  

Barretts Esophagus Clinical Trial

Official title: Endoscopic Tri-Modal Imaging for the Detection of High-Grade Dysplasia and Early Adenocarcinoma in Patients With Barrett's Esophagus: A Randomized Crossover Multi-center Study

Status Completed

Clinical Trial Summary

This study is being done to determine if a new endoscope will help doctors identify pre-cancer or early cancer lesions in patients who have Barrett's esophagus. This new endoscope allows the doctor to look at the lining of the esophagus in 3 different ways by modifying light.

Clinical Trial Description

Patients with Barrett's esophagus are advised to undergo periodic endoscopic surveillance with random biopsies in an attempt to identify high-grade dysplasia (HGD) or early adenocarcinoma (ACA) at a time when intervention can be curative. This approach, however, can be time-consuming and is hindered by low sampling yield and random sampling error. Endoscopic Tri-Modal Imaging (ETMI) is a novel diagnostic modality that encompasses three advanced imaging features in one system: high-resolution endoscopy (HRE), autofluorescence imaging (AFI) and narrow-band imaging (NBI). HRE and AFI provide a bird's-eye view of 'red flag' areas which are then assessed by NBI for focused and more specific tissue characterization. The aim of this prospective, multi-center study is to compare the diagnostic performance of ETMI with that of standard white-light endoscopy (WLE) for identifying high-grade dysplasia (HGD) and early adenocarcinoma (ACA) in BE. A total of 84 BE patients will be recruited for the study and they will undergo both ETMI and WLE examinations in a randomized, crossover fashion. Standard surveillance biopsies and ETMI-targeted biopsies will be performed. The primary outcome will compare the number of patients and lesions with HGD or early ACA detected with WLE and ETMI. It is anticipated that ETMI will enhance the detection of high-grade Barrett's lesions relative to WLE. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adenocarcinoma
• Barrett Esophagus
• Barretts Esophagus
• Early Esophageal Adenocarcinoma
• Esophageal Neoplasms
• High Grade Dysplasia

• NCT number: NCT00586989
• Study type: Observational
• Source: Mayo Clinic
• Status: Completed
• Phase: N/A
• Start date: December 2007
• Completion date: September 2010