Clinical trial · Interventional
"Acetic Acid Chromoendoscopy in Barrett's Esophagus Surveillance
"Acetic Acid Chromoendoscopy in Barrett's Esophagus Surveillance is Superior to the Standardized Random Biopsy Protocol in Detecting Neoplasia: A Prospective Randomized Study"
NCT02614703CI-TRIAL-00053557terminatedPhase 2 / Phase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sample was under-powered
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett's Esophagus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chromoendoscopy using Acetic Acid 2.5% | Drug | — | UNRESOLVED |
| Standard random esophageal biopsies | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 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.
- interventionNames
- Drug: Chromoendoscopy using Acetic Acid 2.5%
- type
- ACTIVE_COMPARATOR
- label
- 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.
- interventionNames
- Other: Standard random esophageal biopsies
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDLongcroft-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
- BACKGROUNDTholoor 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