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

Randomised comparison of endoscopic trimodal imaging versus chromoendoscopy as surveillance strategy for neoplasia in ulcerative colitis - ETMI vs CE in UC

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40535

Enrollment

Registered

2013-07-03

Start date

2013-08-08

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colon cancer dysplasia

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Assymptomatic patients with ulcerative colitis

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Comparing ETMI and CE for detection of neoplasia in patients with ulcerative colitis	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results