The Prevalence, Risk Factors and Optimal Biopsy Protocol of Barrett's Esophagus in Taiwan - A Prospective Randomized Study
Status: Recruiting
Location: See location...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Detections of goblet cells and dysplasia are crucial for diagnosis and determining the surveillance program of Barrett's esophagus (BE). However, the optimal biopsy numbers and their yield rates of intestinal metaplasia (IM) and dysplasia are still uncertain, especially in Asia. The aim of this study was to determine the optimal biopsy protocol of BE.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:
• Adults with columnar-lined esophagus
Locations
Other Locations
Taiwan
E-DA Hospital
RECRUITING
Kaohsiung City
Contact Information
Primary
Ying-Nan Tsai, M.D
littlepig9933@gmail.com
886-7-6150011
Backup
Wen-Lun Wang, Ph.D
warrengodr@gmail.com
886-7-6150011
Time Frame
Start Date: 2023-03-13
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 165
Treatments
Experimental: One biopsy
Obtain one biopsy specimen at the proximal part of the the longest columnar-lined esophagus for patients with suspected Barrett's Esophagus
Active_comparator: Three biopsy
Obtain three biopsy specimens at the proximal, middle and distal part of the longest columnar-lined esophagus for patients with suspected Barrett's Esophagus
Sham_comparator: Seattle protocol
Obtain 4-quadrant biopsy specimens at intervals of every 1 to 2 cm throughout the the columnar-lined esophagus for patients with suspected Barrett's Esophagus
Related Therapeutic Areas
Sponsors
Leads: E-DA Hospital