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NCT06223347 Clinical Trial

Improved and Simplified Staining Technique for Dysplasia Detection in Colitis

Inflammatory Bowel Diseases Clinical Trial

— IST-DDC  

Official title:
A Prospective Trial Comparing Chromoendoscopy to a Digital Staining Technique and White Light in High Definition Colonoscopy in Patients With IBD Attending Scheduled Surveillance Colonoscopy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06223347
Other study ID # 281337
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2024
Est. completion date April 2026

Study information
Verified date January 2024
Source Vastra Gotaland Region
Contact Naz Mohammed Salih, Dr.
Phone +46720267227
Email naz.mohammed.salih@vgregion.se
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Comparing chromoendoscopy to a digital staining technique and White light in patients with IBD attending scheduled surveillance colonoscopy

Description:

In this study we will attempt to compare dye based chromoendoscopy to WLI (white light), NBI( Narrow Band Imaging) and TXI( Texture and Colour Enhancement Imaging). High Definition Colonoscopy is used. We aim to compare all these dye/lights to each other and find the best and simplest method to help to diagnose dysplasia more efficient and easier.

Recruitment information / eligibility
Status Recruiting
Enrollment 106
Est. completion date April 2026
Est. primary completion date April 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Person schedules to IBD- surveillance colonoscopy. Exclusion Criteria: - Total Colectomy. - Not well prepared Bowel. BBPS under 2 at any segement. - Pregnancy.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Chromoendoscopy
Chromoendoscopy: is a dye based staining of colonic mucosa. NBI: is an optical image enhancing technology that allows a detailed inspection of vascular and mucosal patterns, providing the ability to predict histology during real-time endoscopy. TXI: is a digital technique that enhance texture and color of the tissues to be more visible.

Locations
Country Name City State
Sweden Sahlgrenska University Hospital Gothenburg Molndal

Sponsors (1)
Lead Sponsor Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dysplasia detection rate Dysplasia detection rate for each staining technique 90 minutes
Secondary Hyperplasia detection rate Hyperplasia detection rate for each staining technique 90 minutes
Secondary Adenoma detection rate, ADR Adenoma detection rate, ADR, for each staining technique 90 minutes
Secondary Bowel cleansing quality according to Bowel Boston Preparation Scale 90 minutes
Secondary Serious adverse events (significant bleedings and perforations) 90 minutes
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