Randomised comparison of endoscopic trimodal imaging versus chromoendoscopy as surveillance strategy for neoplasia in ulcerative colitis

Completed

• Conditions: colon cancer; dysplasia; 10017990

• Registration Number: NL-OMON40535
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Assymptomatic patients with ulcerative colitis

Exclusion Criteria

- Change in bowel habits in the preceding two months (under maintenance therapy).
- Personal history of (partial) colectomy
- Proven genetic predisposition for colorectal cancer
- Currently known colonic neoplasia
- Non-correctable coagulopathy that precludes taking biopsies
- At introduction active inflammation visible
- Poor bowel preparation
- No informed consent

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Comparing ETMI and CE for detection of neoplasia in patients with ulcerative<br /><br>colitis </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Diagnostic accuracy of ETMI vs. CE for the differentiation of neoplastic and<br /><br>non-neoplastic mucosa, using final histopathology as reference standard<br /><br>diagnosis.<br /><br>- Determination of endoscopic features that predict the presence of a colitis<br /><br>associated dysplasia (CAD), or a sporadic dysplastic lesion (SDL).<br /><br>- The yield of random biopsies, defined by the number of patients with<br /><br>neoplasia detected by random biopsies only (confirmed by histopathology).<br /><br>- Location of neoplasia detected during surveillance colonoscopy<br /><br>- Mean duration of both endoscopic procedures, ETMI vs. CE</p><br>