Health TrialsbyHealthPanel

The Prevalence, Risk Factors and Optimal Biopsy Protocol of BE

ConditionsBarrett's EsophagusIntestinal Metaplasia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorE-DA Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults with columnar-lined esophagus

Disqualifiers

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

Esophageal varices noted during the procedure

Trial design

Design model

Parallel

Treatments tested in this trial

  • One biopsy

    Procedure/Surgery

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

  • Three biopsy

    Procedure/Surgery

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

  • Seattle protocol

    Procedure/Surgery

    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.

  • Endoscopy

    Device

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

Treatment groups

165 Participants
are divided into 3 treatment groups
Group A: One biopsyExperimental treatment 2 interventions
Group B: Three biopsyActive comparator 2 interventions
Group C: Seattle protocolSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

The yield rate of intestinal metaplasia

Defined as the proportion of histologic confirmation of goblet cells

Time frame
Up to 7 days histologic confirmation

Secondary outcomes

1

The yield rate of dysplasia

Defined as the proportion of histologic confirmation of columnar-lined epithelium with dysplasia

Time frame
Up to 7 days histologic confirmation
2

Adverse events

Including bleeding and perforation

Time frame
From the date of procedure until any events, assessed up to 2 weeks
3

Procedure time

Defined as from forcep insertion to biopsy complete

Time frame
From forcep insertion to biopsy complete, assessed up to 1 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

E-DA Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now