No registrations found.
ID
Source
Health condition
- colonoscopy, polyps, differentiation, autofluorescence imaging, narrow-band imaging, chromoendoscopy, confocal endomicroscopy
- colonoscopie, poliepen, differentiatie, autofluorescentie, narrow-band imaging, chromoendoscopie, confocale endomicroscopie
Sponsors and support
1) AFI and Narrow-Band imaging: Olympus, Tokyo, Japan
2) Confocal endomicroscopy: Cell Vizio-GI, Mauna Kea technologies Paris, France
Intervention
Outcome measures
Primary outcome
1. The feasibility of confocal endomicroscopy; represented by:
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;
B. In addition, the percentage of confocal images with insufficient image quality for histopathological diagnosis will be calculated on a per lesion basis.
Secondary outcome
The accuracies of CE, NBI, AFI and confocal endomicroscopy for the endoscopic differentiation of detected lesions will be compared with final histopathology as gold standard.
Background summary
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.
Study objective
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.
Study design
N/A
Intervention
N/A
Inclusion criteria
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.
Exclusion criteria
1. Pregnancy;
2. Beta-blocker use;
3. Non-correctable coagulopathy precluding biopsies;
4. Age under 18 years;
5. Inability to give informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2220 |
| NTR-old | NTR2345 |
| Other | METC AMC : 08/003 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |