"Acetic Acid Chromoendoscopy in Barrett's Esophagus Surveillance

NCT ID: NCT02614703

Last Updated: 2021-08-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-10
• Study Completion Date: 2018-07-30

Brief Summary

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.

Detailed 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.

Conditions

Barrett's Esophagus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Chromoendoscopy using Acetic Acid 2.5%

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.

Group Type: EXPERIMENTAL

Chromoendoscopy using Acetic Acid 2.5%

Intervention Type: DRUG

Spraying esophageal mucosa during random biopsies for Barrett's esophagus

Standard random esophageal biopsies

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.

Group Type: ACTIVE_COMPARATOR

Standard random esophageal biopsies

Intervention Type: OTHER

Random esophageal biopsies performed as per protocol

Interventions

Chromoendoscopy using Acetic Acid 2.5%

Spraying esophageal mucosa during random biopsies for Barrett's esophagus

Intervention Type: DRUG

Standard random esophageal biopsies

Random esophageal biopsies performed as per protocol

Intervention Type: OTHER

Other Intervention Names

chromoendoscopy using ethanoic acid 2.5%

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DHR Health Institute for Research and Development

OTHER

Sponsor Role: lead

Responsible Party

Ingrid Chacon

Gastroenterology Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ingrid M Chacon, MD

Role: PRINCIPAL_INVESTIGATOR

Doctor's Hospital at Renaissance

Locations

Doctors Hospital at Renaissance/Endoscopy Department

Edinburg, Texas, United States

Countries

United States

References

Longcroft-Wheaton G, Duku M, Mead R, Poller D, Bhandari P. Acetic acid spray is an effective tool for the endoscopic detection of neoplasia in patients with Barrett's esophagus. Clin Gastroenterol Hepatol. 2010 Oct;8(10):843-7. doi: 10.1016/j.cgh.2010.06.016. Epub 2010 Jun 30.

Reference Type: BACKGROUND

PMID: 20601133 (View on PubMed)

Tholoor S, Bhattacharyya R, Tsagkournis O, Longcroft-Wheaton G, Bhandari P. Acetic acid chromoendoscopy in Barrett's esophagus surveillance is superior to the standardized random biopsy protocol: results from a large cohort study (with video). Gastrointest Endosc. 2014 Sep;80(3):417-24. doi: 10.1016/j.gie.2014.01.041. Epub 2014 Apr 6.

Reference Type: BACKGROUND

PMID: 24713305 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

0000001

Identifier Type: -

Identifier Source: org_study_id