"Acetic Acid Chromoendoscopy in Barrett's Esophagus Surveillance

Phase 3TerminatedNCT02614703

DHR Health Institute for Research and Development60 enrolled

Overview

Neoplasia in Barrett's esophagus could be missed during routine random biopsies. We propose a study using chromoendoscopy with Acetic Acid to increase the yield of biopsies in detecting neoplasia.

Neoplasia in Barrett's esophagus is often focal and can be missed by nontargeted biopsies alone. In recent years, various advanced endoscopic techniques have been utilized, but with varying success rates. Narrow-band imaging, trimodal imaging, spectral imaging and i-scan are technologies that are manufacturer dependent with limited varying success rates and have financial implications. At our institution, narrow band imaging is routinely utilized as a diagnostic tool for detecting Barrett's esophagus. Acetic acid is a commonly available dye that has been used in the detection of neoplasia in Barrett's esophagus. This study is aimed to prove the effectiveness of acetic acid chromoendoscopy in our Barrett's esophagus surveillance population. The goal is to compare the neoplasia yield of acetic acid chromoendoscopy with that of standardized random biopsy protocol. The sensitivity and specificity for neoplasia detection by these two methods will also be analyzed. Investigators plan to conduct this prospective randomized study for a period of one and a half years (beginning August 1, 2015, ending February 29, 2016). Based on data from 2014, we anticipate to enroll approximately 185 patients. All gastroenterologists (with privileges at Doctors Hospital at Renaissance) will participate in this study. Patients will be randomized to either acetic acid chromoendoscopy or current standard of care (standardized random biopsy protocol utilizing narrow band imaging). Random biopsies from both protocols and targeted biopsies (if identified) will be obtained and submitted to pathology department. These will be reviewed independently by two pathologists. Any discordant results will be reviewed by an outside expert pathologist. Statistical data analysis will be performed utilizing Datadesk XL software.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Barrett's Esophagus

Interventions

Chromoendoscopy using Acetic Acid 2.5%DRUG

Spraying esophageal mucosa during random biopsies for Barrett's esophagus

Standard random esophageal biopsiesOTHER

Random esophageal biopsies performed as per protocol

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients 18 years and older * Previous diagnosis of Barrett's esophagus, confirmed by pathology. Exclusion Criteria: * Patients diagnosed with any level of dysplasia on previous esophageal biopsies. * Patients who had esophageal therapy with Halo radiofrequency ablation in the past, or esophagectomy. * History of allergy to Acetic Acid * History of esophageal dysplasia or cancer * Esophageal ulcerations * Esophageal Candida * Esophageal Varices * Patients with active esophagitis * Patients who cannot provide a valid consent * Patients who are currently pregnant

Locations (1)

Doctors Hospital at Renaissance/Endoscopy Department

Edinburg, Texas, United States

Outcomes

Primary Outcomes

Total Number of Subjects With Neoplasia When Using Acetic Acid Chromoendoscopy Versus Standardized Random Biopsies.

Spray of Acetic Acid into the esophageal mucosa during routine esophageal biopsies for Barrett's esophagus surveillance increases the yield of neoplasia.

Time frame: 142 seconds

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.