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The Prevalence, Risk Factors and Optimal Biopsy Protocol of BE

NCT05818072 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2023-05-11

No results posted yet for this study

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.

Conditions

  • Barrett's Esophagus
  • Intestinal Metaplasia

Interventions

PROCEDURE

One biopsy

To do one biopsy at the proximal part of the longest columnar-lined esophagus.

PROCEDURE

Three biopsy

To do three biopsy at the proximal, middle and distal part of the longest columnar-lined esophagus.

PROCEDURE

Seattle protocol

To do 4-quadrant biopsy every 1-2 cm at the esophagogastric junction. Seattle protocol has been considered as the gold standard biopsy protocol for patients with suspected Barrett's Esophagus.

DEVICE

Endoscopy

The participants will receive meticulous endoscopic examination with narrow-band imaging.

Sponsors & Collaborators

  • E-DA Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-13
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05818072 on ClinicalTrials.gov