"Acetic Acid Chromoendoscopy in Barrett's Esophagus Surveillance

NCT02614703 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 0000001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Barrett's Esophagus

Keywords

Barrett's Esophagus; Acetic Acid Chromoendoscopy

Outcome Measures

Primary Outcomes (1)

• 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.

  142 seconds

Study Arms (2)

Chromoendoscopy using Acetic Acid 2.5%

EXPERIMENTAL

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.

Drug: Chromoendoscopy using Acetic Acid 2.5%

Standard random esophageal biopsies

ACTIVE COMPARATOR

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.

Other: Standard random esophageal biopsies

Interventions

Chromoendoscopy using Acetic Acid 2.5% DRUG

Spraying esophageal mucosa during random biopsies for Barrett's esophagus

Also known as: chromoendoscopy using ethanoic acid 2.5%

Chromoendoscopy using Acetic Acid 2.5%

Standard random esophageal biopsies OTHER

Random esophageal biopsies performed as per protocol

Standard random esophageal biopsies

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years and older
• Previous diagnosis of Barrett's esophagus, confirmed by pathology.

You may not qualify if:

• 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

Sponsors & Collaborators

• DHR Health Institute for Research and Development: lead

Study Sites (1)

Doctors Hospital at Renaissance/Endoscopy Department

Edinburg, Texas, 78539, United States

Location

Related Publications (2)

• 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.

  PMID: 20601133 BACKGROUND

• 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.

  PMID: 24713305 BACKGROUND

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Dr Ingrid M Chacon
• Organization: Dostor's Hospital at Renaissance

I.chacon@dhr-rgv.com

(956) 362-3636

Study Officials

• Ingrid M Chacon, MD

  Doctor's Hospital at Renaissance

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterology Specialist

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: November 25, 2015
• Study Start: March 10, 2017
• Primary Completion: July 30, 2018
• Study Completion: July 30, 2018
• Last Updated: August 27, 2021
• Results First Posted: August 26, 2019

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)