Several new imaging techniques have been developed in order to improve differentiation of colonic lesions, one of these is confocal endomicroscopy. The objective of the proposed study is to evaluate the feasibility and additional value of confocal…
ID
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Aandoening
- colonoscopy, polyps, differentiation, autofluorescence imaging, narrow-band imaging, chromoendoscopy, confocal endomicroscopy
- colonoscopie, poliepen, differentiatie, autofluorescentie, narrow-band imaging, chromoendoscopie, confocale endomicroscopie
Ondersteuning
1) AFI and Narrow-Band imaging: Olympus, Tokyo, Japan
2) Confocal endomicroscopy: Cell Vizio-GI, Mauna Kea technologies Paris, France
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. The feasibility of confocal endomicroscopy; represented by:<br>
A. The sensitivity and specificity of optical biopsies (using final histopathology as gold standard). The sensitivity and specificity will be calculated for both the real time endoscopy diagnosis and the blinded assessment afterwards;<br>
B. In addition, the percentage of confocal images with insufficient image quality for histopathological diagnosis will be calculated on a per lesion basis.
Achtergrond van het onderzoek
Background:
Removal of colonic adenomas prevents the development of colorectal cancer, whereas resection of non-neoplastic lesions expands the endoscopic workload, increases pathology costs and has a risk of complications. Chromoendoscopy (CE), narrow band imaging (NBI) and autofluorescence imaging (AFI) are advanced imaging techniques enabling differentiation of premalignant adenomas and innocent non-neoplastic polyps, however, with insufficient accuracy. Confocal endomicroscopy is a novel imaging technique providing in vivo histology for a more accurate diagnosis during endoscopy.
Aims:
To evaluate the feasibility and accuracy of confocal endomicroscopy during colonoscopic surveillance; (2) To compare the accuracy of CE / NBI / AFI with the accuracy of confocal endomicroscopy for the endoscopic differentiation of adenomatous and non-neoplastic lesions.
Methods:
Patients undergoing colonoscopic surveillance for (serrated) adenomas will be invited for this study. All endoscopically detected lesions will be inspected by CE / NBI / AFI and confocal endomicroscopy for endoscopic prediction of histopathology. Biopsies from those lesions will be used as the gold standard diagnosis.
Outcomes:
1. Feasibility of confocal endomicroscopy (i.e. accuracy and percentage of confocal images with insufficient image quality).
2. Comparison of accuracies of CE, NBI, AFI and confocal endomicroscopy for the endoscopic differentiation of detected lesions.
Doel van het onderzoek
Several new imaging techniques have been developed in order to improve differentiation of colonic lesions, one of these is confocal endomicroscopy. The objective of the proposed study is to evaluate the feasibility and additional value of confocal endomicroscopy, and to compare confocal endomicroscopy with NBI, AFI and chromoendoscopy.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
N/A
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Previous (serrated) adenoma(s) on colonoscopy;
2. Previous colon carcinoma for which partial colectomy was performed;
3. Hereditary non-polyposis colorectal cancer (either genetically proven by a mutation in one of the mismatch repair genes or with a clinical diagnosis according to the Amsterdam II criteria);
4. Positive family history for CRC;
5. Known present (serrated) adenoma(s) or colorectal cancer.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Pregnancy;
2. Beta-blocker use;
3. Non-correctable coagulopathy precluding biopsies;
4. Age under 18 years;
5. Inability to give informed consent.
Opzet
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