"Acetic Acid Chromoendoscopy in Barrett's Esophagus Surveillance

DHR Health

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Barrett's Esophagus

Treatments: Other: Standard random esophageal biopsies; Drug: Chromoendoscopy using Acetic Acid 2.5%

Study type: Interventional

Funder types: Other

Identifiers

NCT02614703

0000001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Chromoendoscopy using Acetic Acid 2.5%

Experimental group

Description:

Patient will have endoscopic examination of esophagus. Esophageal mucosa sprayed with 5cc solution of Acetic Acid 2.5% one time only. Esophageal mucosa examined again. Biopsies are obtained. Abnormal areas identified by Acetic Acid 2.5% will be submitted on separate containers for pathology review. If no abnormalities seen, random biopsies taken as per standard recommendations for Barrett's esophagus. Samples submitted for pathology review.

Treatment:

Drug: Chromoendoscopy using Acetic Acid 2.5%

Standard random esophageal biopsies

Active Comparator group

Description:

Patient will have endoscopic examination of the esophagus. Esophageal mucosa will not be sprayed with Acetic Acid 2.5%. Random biopsies taken as per standard recommendations for Barrett's esophagus. Samples submitted for pathology review.

Treatment:

Other: Standard random esophageal biopsies