Endoscopic Tri-Modal Imaging and Confocal Endomicroscopy for the detection of neoplasia in longstanding ulcerative colitis: a feasibility study.

Endoscopic Tri-Modal Imaging and Confocal Endomicroscopy for the detection of neoplasia in longstanding ulcerative colitis: a feasibility study. - ETMI plus Confocal Endomicroscopy for surveillance of ulcerative colitis.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON31990

Enrollment

Registered

2007-10-24

Start date

2007-10-23

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

inflammatory bowel disease ulcerative colitis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: disease history > 8 years; endoscopic and histopathological evidence of UC; and current inactive disease assessed by the modified Truelove and Witts severity index (of

Exclusion criteria

Exclusion criteria: allergy to fluorescein; non-correctable coagulopathy; age * 18 years; and inability to give informed consent

Design outcomes

Primary

Measure	Time frame
The primary outcomes of this study will be: 1) the neoplasia miss-rate of AFI (per lesion analysis) and 2) the feasibility of confocal endomicroscopy, expressed as diagnostic accuracy when compared to final histopathology.	—

Secondary

Measure	Time frame
Secondary outcomes: 1) the accuracy of AFI plus NBI for the endoscopic diagnosis of lesions compared to confocal endomicroscopy, and 2) the yield for neoplasia of real random biopsies compared to optical biopsies by confocal endomicroscopy.	—

Countries

Netherlands

Outcome results