"Acetic Acid Chromoendoscopy in Barrett's Esophagus Surveillance

Barrett's Esophagus Clinical Trial

Official title:

"Acetic Acid Chromoendoscopy in Barrett's Esophagus Surveillance is Superior to the Standardized Random Biopsy Protocol in Detecting Neoplasia: A Prospective Randomized Study"

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02614703
• Other study ID #: 0000001
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: March 10, 2017
• Est. completion date: July 30, 2018

Study information

• Verified date: August 2021
• Source: DHR Health Institute for Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: July 30, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus

Intervention

Drug:
• Chromoendoscopy using Acetic Acid 2.5%
Spraying esophageal mucosa during random biopsies for Barrett's esophagus

Other:
• Standard random esophageal biopsies
Random esophageal biopsies performed as per protocol

Locations

Country	Name	City	State
United States	Doctors Hospital at Renaissance/Endoscopy Department	Edinburg	Texas

Sponsors (1)

Lead Sponsor	Collaborator
DHR Health Institute for Research and Development

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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