A randomized comparison of Texture Colour Enhancement Imaging (TXI) and Dual Focus magnification (NBI- DF) compared to standard White Light Endoscopy for detection of pre-cancerous changes in adults with Barrett’s Oesophagus

Not Applicable

• Conditions: Barrett's Oesophagus; Oesophageal dysplasia; Early stage oesophageal cancer; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Cancer - Oesophageal (gullet)

• Registration Number: ACTRN12621000893808
• Lead Sponsor: Edward Young

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-08
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

1. Patients aged 18-80 years undergoing surveillance endoscopy for Barrett's Oesophagus (BE) or whom are referred for further assessment of dysplasia/early cancer in BE.

2. Patients with BE length of at least 1cm.

These patients should also be on acid suppressive therapy (Proton Pump Inhibitor at a standard dose for minimum of 4 weeks to prevent inflammation from disrupting interpretation of BE tissue).

Exclusion Criteria

1. Inability or refusal to give informed consent.
2. Patients with coagulation disorders.
3. Patients with significant co morbidity, which includes severe heart failure, chronic renal disease, chronic obstructive airways disease.
4. Patients who are pregnant.
5. Patients taking anti-coagulation medication.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of high-grade dysplasia within Barrett's Oesophagus using Texture and Colour Enhancement Imaging compared to White Light Endoscopy with Narrow-Band Imaging. The sensitivity and specificity will be calculated for both the intervention and control groups compared to histologically confirmed dysplasia on directed or random quadratic biopsies as the gold-standard.[During endoscopy];Detection of adenocarcinoma within Barrett's Oesophagus using Texture and Colour Enhancement Imaging compared to White Light Endoscopy with Narrow-Band Imaging. The sensitivity and specificity will be calculated for both the intervention and control groups compared to histologically confirmed dysplasia on directed or random quadratic biopsies as the gold-standard.[During endoscopy]

Secondary Outcome Measures

Name	Time	Method
Detection of low-grade dysplasia in Barrett's Oesophagus using Texture and Colour Enhancement Imaging versus White Light Endoscopy with Narrow-Band Imaging. The sensitivity and specificity will be calculated for both the intervention and control groups compared to histologically confirmed dysplasia on directed or random quadratic biopsies as the gold-standard.[During endoscopy]