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Endoscopic screening for dysplasia in patients with longstanding ulcerative colitis: Classical chromo-endoscopy versus NBI, FICE and I-scan

Endoscopic screening for dysplasia in patients with longstanding ulcerative colitis: Classical chromo-endoscopy versus NBI, FICE and I-scan - Endoscopic detection of dysplasia in ulcerative colitis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON38174
Enrollment
164
Registered
2012-06-13
Start date
2011-12-01
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

dysplasia ulcerative colitis

Interventions

Screening colonoscopy for ulcerative colitis with different types of colonoscopes and different endoscopic imaging techniques: Group A: Chromo-endoscopy, methylene blue 0.1% (HDTV Olympus) Group B: H

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Signed informed consent form Patients with longstanding ulcerative colitis: at least 8 years after diagnosis or pancolitis and 10 years after diagnosis of left-sided colitis Sex: both males and females Age: above 18 years

Exclusion criteria

Exclusion criteria: Active ulcerative colitis Personal history of colorectal cancer Allergy or intolerance to methylene blue Refusing or incapable to agree with informed consent Pregnant women

Design outcomes

Primary

MeasureTime frame
The main study parameter will be the difference between the three different techniques in the detection of neoplastic lesions in patients with longstanding ulcerative colitis.

Secondary

MeasureTime frame
Other end-points are: number of biopsies taken in the different groups, number of detected neoplastic lesions for each technique, number of detected non-neoplastic lesions for each technique, the total number of advanced adenoma defined as adenoma with high grade dysplasia, villous components, intramucosal carcinoma and angio-invasive growth, proportion of patients with low grade adenoma, proportion of patients with high grade adenoma and the duration of total endoscopic procedure time and of endoscopic procedure time during retraction for each technique.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)