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arrow Band Imaging, Autofluorescence imaging, Chromoendoscopy or Confocal Endomicroscopy for the differentiation of adenomas and non-neoplastic polyps?

Conditions
colorectal adenomas
colorectal polyps
10017990
Registration Number
NL-OMON32325
Lead Sponsor
Academisch Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
85
Inclusion Criteria

1) previous (serrated) adenoma(s) on colonoscopy
2) previous colon carcinoma
3) hereditary non-polyposis colorectal cancer
4) positive family history for CRC
5) known present (serrated) adenoma(s) or colorectal cancer.

Exclusion Criteria

1) allergy to fluorescein
2) pregnancy
3) beta-blocker use
4) non-correctable coagulopathy precluding biopsies
5) age * 18 years
6) inability to give informed consent

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>(1) Feasibility of confocal endomicroscopy (i.e. accuracy and percentage of<br /><br>confocal images with insufficient image quality).</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>(2) Comparison of accuracies of CE, NBI, AFI and confocal endomicroscopy for<br /><br>the endoscopic differentiation of detected lesions.<br /><br>(3) Comparison of interobserver agreement on endoscopic diagnosis by CE, NBI,<br /><br>AFI and confocal endomicroscopy.</p><br>
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