"Acetic Acid Chromoendoscopy in Barrett's Esophagus Surveillance

• Sponsor: DHR Health Institute for Research and Development (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02614703
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 16.7
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Barrett's Esophagus	Drug: Chromoendoscopy using Acetic Acid 2.5%; Other: Standard random esophageal biopsies	Phase 2/Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Diagnostic
• 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"
• Actual Study Start Date: Mar 10, 2017
• Actual Primary Completion Date: Jul 30, 2018
• Actual Study Completion Date: Jul 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Chromoendoscopy using Acetic Acid 2.5%; Spraying esophageal mucosa during random biopsies for Barrett's esophagus; Other Names: chromoendoscopy using ethanoic acid 2.5%
Active Comparator: 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.	Other: Standard random esophageal biopsies; Random esophageal biopsies performed as per protocol

Outcome Measures

Primary Outcome Measures

1. Total Number of Subjects With Neoplasia When Using Acetic Acid Chromoendoscopy Versus Standardized Random Biopsies. [142 seconds]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Doctors Hospital at Renaissance/Endoscopy Department	Edinburg	Texas	United States	78539

Sponsors and Collaborators

• DHR Health Institute for Research and Development

Investigators

• Principal Investigator: Ingrid M Chacon, MD, Doctor's Hospital at Renaissance

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 17, 2016

More Information

Publications

• 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.
• 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.

• Responsible Party: Ingrid Chacon, Gastroenterology Specialist, DHR Health Institute for Research and Development
• ClinicalTrials.gov Identifier: NCT02614703
• Other Study ID Numbers: 0000001
• First Posted: Nov 25, 2015
• Last Update Posted: Aug 27, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ingrid Chacon, Gastroenterology Specialist, DHR Health Institute for Research and Development: Barrett's Esophagus; Acetic Acid Chromoendoscopy
• Additional relevant MeSH terms: Barrett Esophagus; Acetic Acid; Retinol acetate

Study Results

Participant Flow

Recruitment Details	Patients were recruited from our Barrett's esophageal Surveillance Program. The study took place in a South Texas Gastroenterology office. The first patient was enrolled 4-11-17. Study enrollment was stopped 7/30/18.
Pre-assignment Detail	Patients were assigned an arm immediately after enrollment. There were no events within the enrollment and the actual procedure. The only reason patient could have been excluded was a no-show to the procedure appointment.

Arm/Group Title	Chromoendoscopy Using Acetic Acid 2.5%	Standard Random Esophageal Biopsies
Arm/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. Chromoendoscopy using Acetic Acid 2.5%: Spraying esophageal mucosa during random biopsies for Barrett's esophagus	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. Standard random esophageal biopsies: Random esophageal biopsies performed one biopsy per quadrant, every 2cm of Barrett's mucosa ( also known as the Bethesta Protocol)
Period Title: Overall Study
STARTED	31	29
COMPLETED	24	28
NOT COMPLETED	7	1

Baseline Characteristics

Arm/Group Title	Chromoendoscopy Using Acetic Acid 2.5%	Standard Random Esophageal Biopsies	Total
Arm/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. Chromoendoscopy using Acetic Acid 2.5%: Spraying esophageal mucosa during random biopsies for Barrett's esophagus	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. Standard random esophageal biopsies: Random esophageal biopsies performed one biopsy per quadrant, every 2cm of Barrett's mucosa ( also known as the Bethesta Protocol)	Total of all reporting groups
Overall Participants	31	29	60
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	14 45.2%	12 41.4%	26 43.3%
>=65 years	17 54.8%	17 58.6%	34 56.7%
Sex: Female, Male (Count of Participants)
Female	9 29%	14 48.3%	23 38.3%
Male	22 71%	15 51.7%	37 61.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	28 90.3%	25 86.2%	53 88.3%
Not Hispanic or Latino	3 9.7%	4 13.8%	7 11.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	31 100%	29 100%	60 100%
Number of participants with Long Segment Barrett's (participants) [Number]
Number [participants]	10 32.3%	3 10.3%	13 21.7%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Thirty-one (31) patients entered the preliminary data analysis. Of these 31 patients, twenty (20) were classified as SSBE, and eleven (11) patients as Long Segment BE (LSBE). These 31 patients were confirmed to have Barrett's esophagus via biopsy and were randomized (Acetic Acid n=20, Control n=11)

Arm/Group Title	Chromoendoscopy Using Acetic Acid 2.5%	Standard Random Esophageal Biopsies
Arm/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. Chromoendoscopy using Acetic Acid 2.5%: Spraying esophageal mucosa during random biopsies for Barrett's esophagus	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. Standard random esophageal biopsies: Random esophageal biopsies performed as per protocol
Measure Participants	20	11
Number [participants]	1 3.2%	0 0%

Adverse Events

Time Frame	Adverse event data were collected upon completion of the procedure ( minutes to hours after the intervention/procedure). Patients were called 24 hours after the procedure and 48 hours after the procedure. Patients were evaluated at the office two weeks after the procedure.
Adverse Event Reporting Description	No adverse events were reported
Arm/Group Title	Chromoendoscopy Using Acetic Acid 2.5%		Standard Random Esophageal Biopsies
Arm/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. Chromoendoscopy using Acetic Acid 2.5%: Spraying esophageal mucosa during random biopsies for Barrett's esophagus		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. Standard random esophageal biopsies: Random esophageal biopsies performed one biopsy per quadrant, every 2cm of Barrett's mucosa ( also known as the Bethesta Protocol)
All Cause Mortality
	Chromoendoscopy Using Acetic Acid 2.5%		Standard Random Esophageal Biopsies
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/29 (0%)
Serious Adverse Events
	Chromoendoscopy Using Acetic Acid 2.5%		Standard Random Esophageal Biopsies
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/29 (0%)
Other (Not Including Serious) Adverse Events
	Chromoendoscopy Using Acetic Acid 2.5%		Standard Random Esophageal Biopsies
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/29 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.