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ID05818072

Study on the Best Biopsy Method and Risk Factors for Barretts Esophagus in Taiwan A Randomized Trial Comparing Biopsy Protocols for Diagnosing Barretts Esophagus

Led by E-DA Hospital · Updated on 2023-05-11

165

Participants Needed

1

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating Barretts esophagus BE, a condition where the normal lining of the lower esophagus changes and can lead to esophageal adenocarcinoma, a type of cancer. This study aims to determine the best biopsy method to detect intestinal metaplasia IM and dysplasia, which are important for diagnosis and deciding surveillance plans, especially in Asian populations where the prevalence of BE and related gastroesophageal reflux disease GERD has been increasing. Participants with suspected BE will undergo one of three biopsy protocols during endoscopy one biopsy at the upper part of the longest columnar-lined esophagus, three biopsies at the upper, middle, and lower parts, or the Seattle protocol involving four-quadrant biopsies every 1-2 cm along the esophagus. The Seattle protocol is considered the standard but is time-consuming, and this study compares it to simpler methods. All participants will also receive a detailed endoscopic exam using narrow-band imaging. Throughout the study, researchers will monitor biopsy results to measure the detection rates of intestinal metaplasia and dysplasia. They will also record procedure times and any adverse events up to two weeks after the procedure. The study involves random assignment to biopsy methods and single masking. Participants will be followed closely for up to seven days for histologic confirmation and monitored for safety during and after the procedures.

CONDITIONS

Brief Title

The Prevalence, Risk Factors and Optimal Biopsy Protocol of BE

Research Team

Y

Ying-Nan Tsai, M.D

W

Wen-Lun Wang, Ph.D

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