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The Prevalence, Risk Factors and Optimal Biopsy Protocol of BE

Key facts

Who runs it
E-DA Hospital
Where
Taiwan1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
165 people, planned
Started
13 Mar 2023
Expected to end
31 Dec 2026
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • One biopsy
  • Three biopsy
  • Seattle protocol
  • Endoscopy
Record updated
11 May 2023

Who can take part

Age
20 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • Adults with columnar-lined esophagus

Who cannot take part

  • 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
  • Taking antiplatelet drug or anticoagulant
  • Esophageal varices noted during the procedure
  • Uncontrolled coagulopathy

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • One biopsyTreatment being tested

    Obtain one biopsy specimen at the proximal part of the the longest columnar-lined esophagus for patients with suspected Barrett's Esophagus

    Treatment: One biopsy and Endoscopy

  • Three biopsyExisting treatment, for comparison

    Obtain three biopsy specimens at the proximal, middle and distal part of the longest columnar-lined esophagus for patients with suspected Barrett's Esophagus

    Treatment: Three biopsy and Endoscopy

  • Seattle protocolSham treatment, for comparison

    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

    Treatment: Seattle protocol and Endoscopy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
The Prevalence, Risk Factors and Optimal Biopsy Protocol of Barrett's Esophagus in Taiwan - A Prospective Randomized Study
Record updated
11 May 2023