Clinical trial · Observational
Barrett's Esophagus Related Neoplasia (BERN) Project
Endoscopic Detection of Early Neoplasia in Patients With Barrett's Esophagus
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
* The use of high resolution endoscopy (HRE), narrow band imaging (NBI) and chromoendoscopy increases the detection rates of Barrett's esophagus (BE) and early neoplasia. * Endoscopic mucosal resection (EMR) will improve the accuracy for detection of dysplasia/early neoplasia. Specific Aim 1 - To create a video-atlas of non-dysplastic and dysplastic/early neoplastic lesions in patients with BE. This will be used for training purposes and to assess learning curve associated with these new technologies. Specific Aim 2 - To create a standardized classification system for the mucosal and vascular patterns observed in patients with BE. Specific Aim 3 - To determine the interobserver agreement using the video-atlas for the mucosal and vascular patterns classification agreed upon. Specific Aim 4 - To determine the endoscopic detection rate of esophageal cancer or precancerous lesions removed during endoscopy. Specific Aim 5 - To determine the pathologic and clinical outcomes of patients undergoing EMR/ablation; including morbidity, mortality and complications of the procedure. Results to date (June 2008) : this study is active and open to enrollment. Currently 26 patients have enrolled in this study at the Kansas City VA medical center. In order to participate, patients must be eligible for care at the KCVA hospital.
Conditions
Conditions (3)
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 | — |
| Gastroesophageal Reflux | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Video-atlas creation
- timeFrame
- March 2007 - June 2016
- description
- To create a video-atlas of early neoplastic lesions in patients with BE. This will be used for training purposes and to assess learning curve associated with these new technologies.
- measure
- Pathologic and Clinical Outcomes
- timeFrame
- 2007 - 2016
- description
- To determine the pathologic and clinical outcomes of patients undergoing EMR / ablation; including morbidity, mortality and complications of the procedure.
Secondary outcomes (2)
- measure
- Interobserver agreement for the detection of early neoplasia
- timeFrame
- 2015 - 2016
- description
- To determine the interobserver agreement using the video-atlas for the detection of early neoplasia.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18-80 years * Patients must be able to provide written informed consent * Patients referred for endoscopy for screening/surveillance of BE or for endoscopic treatment of BE with early mucosal neoplasia Exclusion Criteria: * Current use of aspirin, non-steroidal anti-inflammatory agents(NSAIDs),or chronic anticoagulants that cannot be discontinued prior to the procedure. * Inability to provide written informed consent * Significant thrombocytopenia or coagulopathy * Any significant co-morbid condition that would prevent the safe administration of conscious sedation
References
Publications (0)
Data not yet available