Image Enhanced Endoscopy IBD

Not Applicable

Recruiting

• Conditions: Inflammatory Bowel Diseases; Dysplasia
• Interventions: Procedure: Image Enhanced Endoscopy Filters

• Registration Number: NCT06266104
• Lead Sponsor: Royal Perth Hospital

Brief Summary

Dye- spray chromoendoscopy remains the recommended gold standard approach for IBD dysplasia surveillance colonoscopy however recently published European and American guidelines recommend either dye-spray or virtual chromoendoscopy can be used for surveillance. The newer Imaged Enhanced Endoscopy technologies TXI and LCI have not formally been evaluated in IBD surveillance in a randomised controlled trial setting. These modes can easily be applied during colonoscopy and if demonstrated to be effective may save time and eliminate the need for dye-spray chromoendoscopy in the future.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-04
• Study First Submitted QC: 2024-02-10
• Study First Posted: 2024-02-20
• Status Verified: 2024-04
• Study Start: 2024-04-03
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-12
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

• Patients with inflammatory bowel disease aged 18 to 75 years, that meet Australian recommendations to undergo surveillance colonoscopy will be identified and invited participate in the study.

Exclusion Criteria

• Any active disease
• Inadequate bowel preparation
• Previous surgical resection involving the colon
• History of bowel cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TXI	Image Enhanced Endoscopy Filters	Patients undergoing surveillance with TXI (Texture and Colour Enhancement Imaging)
Dye Spray Chromoendoscopy	Image Enhanced Endoscopy Filters	Patients undergoing surveillance with dye spray chromoendoscopy
LCI	Image Enhanced Endoscopy Filters	Patients undergoing surveillance with LCI (Linked Colour Imaging )

Primary Outcome Measures

Name	Time	Method
Dysplasia Detection Rate	2 years	Overall Dysplasia Detection rate

Secondary Outcome Measures

Name	Time	Method
Characterisation of lesions	2 years	Accurate characterisation compared to histology
Withdrawal times	2 years	Withdrawal time for procedure

Trial Locations

Locations (1)

Royal Perth Hosptial; 🇦🇺 Perth, Western Australia, Australia