Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
ID05818072

The Prevalence, Risk Factors and Optimal Biopsy Protocol of Barrett's Esophagus in Taiwan - A Prospective Randomized Study

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

165

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating Barrett's 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

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults with columnar-lined esophagus
Not Eligible

You will not qualify if you...

  • Prior endoscopic treatment for Barrett's Esophagus
  • History of upper gastrointestinal malignancy
  • History of total or subtotal gastrectomy
  • Presence of esophageal varices during procedure
  • Uncontrolled coagulopathy
  • Taking antiplatelet or anticoagulant medications

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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)

Long-term Monitoring

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

Trial Site Locations

Total: 1 location

1

E-DA Hospital

Kaohsiung City, Taiwan, 82445

Actively Recruiting

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Research Team

Y

Ying-Nan Tsai, M.D

W

Wen-Lun Wang, Ph.D

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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Published Research Related To This Trial

Incidence of esophageal adenocarcinoma in Barrett's esophagus with low-grade dysplasia: a systematic review and meta-analysis.

Siddharth Singh, Palaniappan Manickam, Anita V Amin...

https://pubmed.ncbi.nlm.nih.gov/24556051

Incidence of esophageal adenocarcinoma in patients with Barrett's esophagus and high-grade dysplasia: a meta-analysis.

Amit Rastogi, Srinivas Puli, Hashem B El-Serag...

https://pubmed.ncbi.nlm.nih.gov/18045592

Lower Annual Rate of Progression of Short-Segment vs Long-Segment Barrett's Esophagus to Esophageal Adenocarcinoma.

Nour Hamade, Sreekar Vennelaganti, Sravanthi Parasa...

https://pubmed.ncbi.nlm.nih.gov/30012433

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

Adherence to biopsy guidelines for Barrett's esophagus surveillance in the community setting in the United States.

Julian A Abrams, Robert C Kapel, Guy M Lindberg...

https://pubmed.ncbi.nlm.nih.gov/19268726