|- candidate number||8095|
|- NTR Number||NTR2345|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||28-mei-2010|
|- Secondary IDs||08/003 METC AMC|
|- Public Title||New endoscopic imaging techniques for the differentiation of polyps in the colon.|
|- Scientific Title||Narrow Band Imaging (NBI), Autofluorescence imaging (AFI), Chromoendoscopy or Confocal Endomicroscopy for the differentiation of adenomas and non-neoplastic polyps?|
|- hypothesis||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. |
|- Healt Condition(s) or Problem(s) studied||Polyps, Autofuorecence imaging , Narrow band imaging, Colonoscopy, Chromoendoscopy, Confocal endomicroscopy, Differentiation|
|- 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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-feb-2008|
|- planned closingdate||1-jul-2010|
|- Target number of participants||85|
|- 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.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| T. Kuiper|
|- CONTACT for SCIENTIFIC QUERIES||MD, PhD Evelien Dekker|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Olympus, Tokyo, Japan, Cell Vizio-GI, Mauna Kea technologies Paris, France|
|- Brief 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.
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.
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.
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.
|- Main changes (audit trail)|
|- RECORD||28-mei-2010 - 5-jun-2010|