Actively Recruiting
Endoscopic Detection of Early Neoplasia in Patients With Barrett's Esophagus
Led by Midwest Biomedical Research Foundation · Updated on 2024-11-22
150
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
M
Midwest Biomedical Research Foundation
Lead Sponsor
K
Kansas City Veteran Affairs Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying Barrett's Esophagus (BE), a condition caused by chronic acid reflux that increases the risk of esophageal cancer. This study evaluates advanced endoscopic techniques such as high resolution endoscopy (HRE), narrow band imaging (NBI), and chromoendoscopy to improve the detection of early neoplastic changes in BE. The study also aims to develop a video atlas and classification system to help recognize these changes and assess their accuracy and agreement among observers. The study involves performing standard endoscopy followed by HRE, NBI, and chromoendoscopy on patients with BE. Abnormal lesions identified during endoscopy will be removed using endoscopic mucosal resection (EMR) or mucosal ablation. Digital video recordings of these procedures will be collected for analysis. This is part of a multicenter study with patients recruited from various locations. Patients will also complete questionnaires about their reflux symptoms and medication use. Participants will undergo physical exams, complete questionnaires, and have their endoscopic procedures recorded and analyzed. Researchers will track the detection rates of early esophageal cancer or precancerous lesions and review pathologic and clinical outcomes including any complications from EMR or ablation. The study will also assess agreement between observers using the video atlas and classification system. Participation may last several years, with ongoing monitoring of outcomes from 2007 through 2016.
CONDITIONS
Brief Title
Barrett's Esophagus Related Neoplasia (BERN) Project
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Able to provide written informed consent
- Referred for endoscopy for screening or surveillance of Barrett's Esophagus
- Referred for endoscopic treatment of Barrett's Esophagus with early mucosal neoplasia
You will not qualify if you...
- Current use of aspirin, NSAIDs, or chronic anticoagulants that cannot be stopped before the procedure
- Unable to provide written informed consent
- Significant thrombocytopenia or blood clotting disorders
- Any serious medical condition that prevents safe conscious sedation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Single day procedure
Participants undergo endoscopic procedures including high-resolution endoscopy, narrow band imaging, and chromoendoscopy to detect early neoplasia in Barrett's Esophagus.
1 visit (in-person)
Duration - Up to 9 years
Participants are observed over time to assess pathologic and clinical outcomes related to Barrett's Esophagus and early neoplasia.
Follow-up visits as per routine care and study assessments
Trial Site Locations
Total: 1 location
1
Kansas city VA Medical center
Kansas City, Missouri, United States, 64128
Actively Recruiting
Research Team
A
April Higbee, BN
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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