Endoscopic Tri-Modal Imaging versus standard video endoscopy for the detection of early neoplasia in patients with low-grade dysplasia in a Barrett's oesophagus: a multicentre randomised cross-over controlled study

Completed

• Conditions: Barrett's oesophagus; Digestive System; Diseases of oesophagus

• Registration Number: ISRCTN91816824
• Lead Sponsor: Academic Medical Centre (AMC) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-01
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 96

Inclusion Criteria

1. Barrett's oesophagus patients with low-grade dyplasia comfirmed by two expert GastroIntestinal (GI) pathologists
2. Written informed consent

Exclusion Criteria

1. Presence of active erosive oesophagitis grade A according to the Los Angeles classification of erosive oesophagitis
2. Presence of conditions precluding histological sampling of the oesophagus (e.g. oesophageal varices, coagulation disorders, anticoagulant therapy)
3. Less than 18 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Number of patients with early neoplasia detected with ETMI or SVE<br>2. Number of lesions with early neoplasia detected with ETMI and SVE

Secondary Outcome Measures

Name	Time	Method
1. Number of early neoplastic lesions detected with AutoFluorescence Imaging (AFI) only<br>2. Reduction of false positives findings after detailed Narrow Band Imaging (NBI) evaluation