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"Acetic Acid Chromoendoscopy in Barrett's Esophagus Surveillance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02614703
Recruitment Status : Terminated (Sample was under-powered)
First Posted : November 25, 2015
Results First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Ingrid Chacon, MD, Doctors Hospital at Renaissance

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Diagnostic
Condition Barrett's Esophagus
Interventions Drug: Chromoendoscopy using Acetic Acid 2.5%
Other: Standard random esophageal biopsies
Enrollment 60
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 Details 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
Hide 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
Reason Not Completed
Withdrawal by Subject             7             1
Arm/Group Title Chromoendoscopy Using Acetic Acid 2.5% Standard Random Esophageal Biopsies Total
Hide 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 Number of Baseline Participants 31 29 60
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 29 participants 60 participants
<=18 years
0
   0.0%
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 29 participants 60 participants
Female
9
  29.0%
14
  48.3%
23
  38.3%
Male
22
  71.0%
15
  51.7%
37
  61.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 29 participants 60 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%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants 29 participants 60 participants
31 29 60
Number of participants with Long Segment Barrett's   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 31 participants 29 participants 60 participants
10 3 13
[1]
Measure Description:

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.

1.Primary Outcome
Title Total Number of Subjects With Neoplasia When Using Acetic Acid Chromoendoscopy Versus Standardized Random Biopsies.
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 20 11
Measure Type: Number
Unit of Measure: participants
1 0
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
Hide 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 (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/29 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Chromoendoscopy Using Acetic Acid 2.5% Standard Random Esophageal Biopsies
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/29 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Chromoendoscopy Using Acetic Acid 2.5% Standard Random Esophageal Biopsies
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/29 (0.00%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Ingrid M Chacon
Organization: Dostor's Hospital at Renaissance
Phone: (956) 362-3636
EMail: I.chacon@dhr-rgv.com
Layout table for additonal information
Responsible Party: Ingrid Chacon, MD, Doctors Hospital at Renaissance
ClinicalTrials.gov Identifier: NCT02614703     History of Changes
Other Study ID Numbers: 0000001
First Submitted: July 30, 2015
First Posted: November 25, 2015
Results First Submitted: March 20, 2019
Results First Posted: August 26, 2019
Last Update Posted: August 26, 2019