Image Enhanced Endoscopy IBD

NCT ID: NCT06266104

Last Updated: 2024-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-03

Study Completion Date

2026-03-01

Brief Summary

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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

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Conditions

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Inflammatory Bowel Diseases Dysplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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Dye Spray Chromoendoscopy

Patients undergoing surveillance with dye spray chromoendoscopy

Group Type PLACEBO_COMPARATOR

Image Enhanced Endoscopy Filters

Intervention Type PROCEDURE

Patients that undergoing surveillance and consent to be involved in the study will be randomised to undergo surveillance with LCI, TXI or dye-spray chromoendoscopy (methylene blue).

TXI

Patients undergoing surveillance with TXI (Texture and Colour Enhancement Imaging)

Group Type ACTIVE_COMPARATOR

Image Enhanced Endoscopy Filters

Intervention Type PROCEDURE

Patients that undergoing surveillance and consent to be involved in the study will be randomised to undergo surveillance with LCI, TXI or dye-spray chromoendoscopy (methylene blue).

LCI

Patients undergoing surveillance with LCI (Linked Colour Imaging )

Group Type ACTIVE_COMPARATOR

Image Enhanced Endoscopy Filters

Intervention Type PROCEDURE

Patients that undergoing surveillance and consent to be involved in the study will be randomised to undergo surveillance with LCI, TXI or dye-spray chromoendoscopy (methylene blue).

Interventions

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Image Enhanced Endoscopy Filters

Patients that undergoing surveillance and consent to be involved in the study will be randomised to undergo surveillance with LCI, TXI or dye-spray chromoendoscopy (methylene blue).

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Royal Perth Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sherman Picardo

Doctor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Royal Perth Hosptial

Perth, Western Australia, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Sherman Picardo, MBBS (hon), MSc

Role: CONTACT

0892242244

Facility Contacts

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Sherman Picardo, MBBS

Role: primary

92242244

Other Identifiers

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Protocol V1.4_04012024

Identifier Type: -

Identifier Source: org_study_id

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