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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chromoendoscopy using Acetic Acid 2.5% | Drug | Spraying esophageal mucosa during random biopsies for Barrett's esophagus |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ingrid M Chacon, MD | Doctor's Hospital at Renaissance | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Doctors Hospital at Renaissance/Endoscopy Department | Edinburg | Texas | 78539 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20601133 | Background | 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. | |
| 24713305 | 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. |
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There is no plan to make individual data available unless otherwise asked for safety reason.
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Chromoendoscopy using Acetic Acid 2.5%: Spraying esophageal mucosa during random biopsies for Barrett's esophagus |
| FG001 | 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. Standard random esophageal biopsies: Random esophageal biopsies performed one biopsy per quadrant, every 2cm of Barrett's mucosa ( also known as the Bethesta Protocol) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Six patients randomized to the Acetic Acid arm, and four patients randomized to the standard random biopsies did not show to the test study by personal choice. Seven patients randomized to the Acetic Acid arm, and thirteen patients randomized to the Standard random esophageal biopsies did not have biopsy confirmed Barrett's esophagus.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Chromoendoscopy using Acetic Acid 2.5%: Spraying esophageal mucosa during random biopsies for Barrett's esophagus |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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) | Posted | Number | participants | 142 seconds |
|
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.
No adverse events were reported
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Chromoendoscopy using Acetic Acid 2.5%: Spraying esophageal mucosa during random biopsies for Barrett's esophagus |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Ingrid M Chacon | Dostor's Hospital at Renaissance | (956) 362-3636 | I.chacon@dhr-rgv.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 17, 2016 | Sep 25, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Standard random esophageal biopsies | Other | Random esophageal biopsies performed as per protocol |
|
| BG001 | 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. Standard random esophageal biopsies: Random esophageal biopsies performed one biopsy per quadrant, every 2cm of Barrett's mucosa ( also known as the Bethesta Protocol) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of participants with Long Segment Barrett's | Measurement of the length of Barrett's esophagus is performed during procedure. Length is reported in centimeters and is subjectively given by endoscopist performing procedure. Segments less than 3cm in maximal length are classified as short segment. Segments over 3cm in maximal length are classified as long segment. | Number | participants |
|
| OG001 | 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. Standard random esophageal biopsies: Random esophageal biopsies performed as per protocol |
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | 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. Standard random esophageal biopsies: Random esophageal biopsies performed one biopsy per quadrant, every 2cm of Barrett's mucosa ( also known as the Bethesta Protocol) | 0 | 29 | 0 | 29 | 0 | 29 |
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| D004066 |
| Digestive System Diseases |