Trial Outcomes & Findings for "Acetic Acid Chromoendoscopy in Barrett's Esophagus Surveillance (NCT NCT02614703)

NCT ID: NCT02614703

Last Updated: 2021-08-27

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE2/PHASE3
• Target enrollment: 60 participants
• Primary outcome timeframe: 142 seconds
• Results posted on: 2021-08-27

Participant Flow

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.

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.

Participant milestones

Measure	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	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)
Overall Study STARTED	31	29
Overall Study COMPLETED	24	28
Overall Study NOT COMPLETED	7	1

Reasons for withdrawal

Measure	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	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)
Overall Study Withdrawal by Subject	7	1

Baseline Characteristics

"Acetic Acid Chromoendoscopy in Barrett's Esophagus Surveillance

Baseline characteristics by cohort

Measure	Chromoendoscopy Using Acetic Acid 2.5% n=31 Participants 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	Standard Random Esophageal Biopsies n=29 Participants 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 n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	14 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	15 Participants n=7 Participants	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	28 Participants n=5 Participants	25 Participants n=7 Participants	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants	29 participants n=7 Participants	60 participants n=5 Participants
Number of participants with Long Segment Barrett's	10 participants n=5 Participants	3 participants n=7 Participants	13 participants n=5 Participants

PRIMARY outcome

Timeframe: 142 seconds

Population: 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)

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

Outcome measures

Measure	Chromoendoscopy Using Acetic Acid 2.5% n=20 Participants 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	Standard Random Esophageal Biopsies n=11 Participants 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
Total Number of Subjects With Neoplasia When Using Acetic Acid Chromoendoscopy Versus Standardized Random Biopsies.	1 participants	0 participants

Adverse Events

Chromoendoscopy Using Acetic Acid 2.5%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Random Esophageal Biopsies

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Ingrid M Chacon

Dostor's Hospital at Renaissance

Phone: (956) 362-3636

Email: I.chacon@dhr-rgv.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place