"Acetic Acid Chromoendoscopy in Barrett's Esophagus Surveillance
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|ClinicalTrials.gov Identifier: NCT02614703|
Recruitment Status : Recruiting
First Posted : November 25, 2015
Last Update Posted : March 14, 2017
|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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||185 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 :||March 10, 2017|
|Estimated Primary Completion Date :||September 13, 2018|
|Estimated Study Completion Date :||December 13, 2018|
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 Name: 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
- Total number of subjects with neoplasia when using acetic acid chromoendoscopy versus standardized random biopsies. [ Time Frame: 18 months ]Spray of Acetic Acid into the esophageal mucosa during routine esophageal biopsies for Barrett's esophagus surveillance increases the yield of neoplasia.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02614703
|Contact: Ivy Hernandez, RN||9563627391||Ivy.Hernandez@dhr-rgv.com|
|Contact: Ingrid M Chacon, MDfirstname.lastname@example.org|
|United States, Texas|
|Doctors Hospital at Renaissance/Endoscopy Department||Recruiting|
|Edinburg, Texas, United States, 78539|
|Contact: Ivy Hernandez, RN 956-362-7391 Ivy.email@example.com|
|Contact: Ingrid Chacon, MD 956-207-9844 I.Chacon@dhr-rgv.com|
|Principal Investigator: Ingrid Chacon, MD|
|Principal Investigator:||Ingrid M Chacon, MD||Doctor's Hospital at Renaissance|