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Endoscopic Tri-Modal Imaging (ETMI) for the detection and classification of early colorectal neoplasia; a multi-center randomized controlled trial


- candidate number2705
- NTR NumberNTR1039
- ISRCTNISRCTN64206478
- Date ISRCTN created5-sep-2007
- date ISRCTN requested31-aug-2007
- Date Registered NTR20-aug-2007
- Secondary IDs 
- Public TitleEndoscopic Tri-Modal Imaging (ETMI) for the detection and classification of early colorectal neoplasia; a multi-center randomized controlled trial
- Scientific TitleEndoscopic Tri-Modal Imaging (ETMI) for the detection and classification of early colorectal neoplasia; a multi-center randomized controlled trial
- ACRONYM
- hypothesisEndoscopic Tri-Modal Imaging increases the detection rate of colorectal adenomas compared to conventional colonoscopy.
- Healt Condition(s) or Problem(s) studiedColorectal, Neoplasia, Adenomas, Colonoscopy, Imaging, Detection
- Inclusion criteriaPatients (>18 years) undergoing colonoscopic surveillance because of: a. history of adenomatous polyps. b. history of CRC. c. Hereditary Non-Polyposis Colorectal Cancer d. family history of CRC/adenomas
- Exclusion criteria1. Poor bowel preparation; 2. Familial Adenomatous Polyposis, attenuated FAP, MYH associated polyposis or hyperplastic polyposis; 3. History of inflammatory bowel disease; 4. Presence of conditions precluding histological sampling of the colon (e.g. coagulation disorders, anticoagulant therapy).
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 10-jul-2007
- planned closingdate31-dec-2008
- Target number of participants234
- InterventionsETMI tandem colonoscopy: High resolution endoscopy (HRE) followed by autofluorescence imaging (AFI). Conventional colonoscopy: Standard resolution colonoscopy followed by standard resolution colonoscopy.
- Primary outcomeNumber of adenomas detected by ETMI versus conventional colonoscopy.
- Secondary outcome1. Number of adenomas detected by HRE versus conventional colonoscopy; 2. Miss rate of HRE as followed by AFI (additional yield of AFI); 3. Accuracy of NBI and AFI in discriminating non-neoplastic from neoplastic lesions (Kudo classification and color)
- Timepoints
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD, PhD Evelien Dekker
- CONTACT for SCIENTIFIC QUERIESMD, PhD Evelien Dekker
- Sponsor/Initiator Academic Medical Center (AMC), Department of Hepato- and Gastroenterology
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryColorectal adenomas are being missed by standard colonoscopy in about 22%. New imaging techniques try to reduce miss rates. Endoscopic Tri-Modal Imaging (ETMI) incorporates (1) autofluorescence imaging and (2) high resolution endoscopy for detection, and (3) narrow band imaging for classification. This study compares adenoma detection rates of ETMI with standard colonoscopy and evaluates the use of AFI and NBI for correct endoscopic diagnosis.
- Main changes (audit trail)
- RECORD20-aug-2007 - 24-sep-2007


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