Expired Study
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Edinburg, Texas 78539


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

0000001


NCT ID:

NCT02614703


Secondary ID:


Study Acronym:


Brief Title:

"Acetic Acid Chromoendoscopy in Barrett's Esophagus Surveillance


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"


Overall Status:

Terminated


Study Phase:

Phase 2/Phase 3


Genders:

N/A


Minimum Age:

40 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Doctors Hospital at Renaissance


Oversight Authority:

  • United States: Institutional Review Board
  • United States: Food and Drug Administration


Reasons Why Stopped:

Sample was under-powered


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

60


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:March 10, 2017
Completion Date:July 30, 2018
Completion Type:Actual
Primary Completion Date:July 30, 2018
Primary Completion Type:Actual
Verification Date:August 2019
Last Changed Date:August 22, 2019
First Received Date:July 30, 2015
First Results Date:March 20, 2019

Study Outcomes

Outcome Type:Primary Outcome
Measure:Total Number of Subjects With Neoplasia When Using Acetic Acid Chromoendoscopy Versus Standardized Random Biopsies.
Time Frame:142 seconds
Safety Issues:False
Description:Spray of Acetic Acid into the esophageal mucosa during routine esophageal biopsies for Barrett's esophagus surveillance increases the yield of neoplasia.

Study Interventions

Intervention Type:Drug
Name:Chromoendoscopy using Acetic Acid 2.5%
Description:Spraying esophageal mucosa during random biopsies for Barrett's esophagus
Arm Name:Chromoendoscopy using Acetic Acid 2.5%
Other Name:chromoendoscopy using ethanoic acid 2.5%
Intervention Type:Other
Name:Standard random esophageal biopsies
Description:Random esophageal biopsies performed as per protocol
Arm Name:Standard random esophageal biopsies

Study Arms

Study Arm Type:Active Comparator
Arm Name:Standard random esophageal biopsies
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.
Study Arm Type:Experimental
Arm Name:Chromoendoscopy using Acetic Acid 2.5%
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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Doctors Hospital at Renaissance

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
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.
PMID:24713305
Reference Type:Reference
Citation: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

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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