British Society of Gastroenterology guidelines on the diagnosis and management of Barrett's oesophagus.
Rebecca C Fitzgerald, Massimiliano di Pietro, Krish Ragunath...
https://pubmed.ncbi.nlm.nih.gov/24165758/Actively Recruiting
Led by E-DA Hospital · Updated on 2023-05-11
165
Participants Needed
1
Research Sites
52 weeks
Total Duration
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
The Prevalence, Risk Factors and Optimal Biopsy Protocol of BE
Y
Ying-Nan Tsai, M.D
W
Wen-Lun Wang, Ph.D
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E-DA Hospital
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive an endoscopic examination with narrow-band imaging and undergo biopsy procedures to assess intestinal metaplasia and dysplasia in the esophagus using one of three biopsy protocols.
1 procedure visit (in-person)
Duration - Up to 2 weeks
Participants are monitored for adverse events and biopsy results following the procedure.
Follow-up visits as needed within 2 weeks
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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