Investigating the best biopsy methods for Barrett's Esophagus
The Prevalence, Risk Factors and Optimal Biopsy Protocol of Barrett's Esophagus in Taiwan - A Prospective Randomized Study
This study is testing different biopsy methods to see which one works best for finding early signs of Barrett's Esophagus in patients, especially in Asian populations.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 165 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | E-DA Hospital Academic / other |
| Locations | 1 site (Kaohsiung City) |
| Trial ID | NCT05818072 on ClinicalTrials.gov |
What this trial studies
This study aims to determine the optimal biopsy protocol for Barrett's Esophagus (BE), a condition that can lead to esophageal adenocarcinoma. It focuses on the prevalence and risk factors associated with BE, particularly in Asian populations, where data is limited. The study will compare different biopsy methods, including one biopsy, three biopsies, and the Seattle protocol, to assess their effectiveness in detecting intestinal metaplasia and dysplasia. By understanding the best practices for biopsy, the study seeks to improve surveillance and management of patients with BE.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with a columnar-lined esophagus.
Not a fit: Patients with a history of endoscopic treatment for Barrett's Esophagus or upper gastrointestinal malignancy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance early detection and management of Barrett's Esophagus, potentially reducing the risk of progression to esophageal cancer.
How similar studies have performed: Other studies have indicated the importance of biopsy protocols in Barrett's Esophagus, but this specific approach in the Asian context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults with columnar-lined esophagus Exclusion Criteria: * A prior history of endoscopic treatment for Barrett's Esophagus * A prior history of upper gastrointestinal malignancy * A prior history of total or subtotal gastrectomy * Esophageal varices noted during the procedure * Uncontrolled coagulopathy * Taking antiplatelet drug or anticoagulant
Where this trial is running
Kaohsiung City
- E-DA Hospital — Kaohsiung City, Taiwan (Recruiting)
Study contacts
- Study coordinator: Ying-Nan Tsai, M.D
- Email: littlepig9933@gmail.com
- Phone: 886-7-6150011
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.