|- candidate number||10824|
|- NTR Number||NTR3235|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-jan-2012|
|- Secondary IDs||MEC 10/299 METC AMC |
|- Public Title||Diagnosing small lesions in the colon using the WavSTAT device.|
|- Scientific Title||Differentiation of small colorectal lesions; laser-induced autofluorescence using the WavSTAT.|
|- hypothesis||The current study evaluates whether accurate optical diagnosis of small colorectal polyps (<10mm) can be achieved using both the endoscopic image as well as an optical device called the WavSTAT. Accurate optical diagnose could result in the omission of formal histopathology, which could make colonoscopy more efficient and cost effective.|
|- Healt Condition(s) or Problem(s) studied||Differentiation, Colonoscopy, White-light, Optical diagnosis, WavSTAT|
|- Inclusion criteria||1. Age > 18 years;|
2. Patients who are advised to undergo colonoscopic surveillance because of:
A. A history of adenomatous polyps;
B. Symptoms (e.g. change in bowel habits);
C. Family history of CRC.
|- Exclusion criteria||1. Poor bowel preparation (scoring ≤ 4 points on the Boston Bowel Preparation Scale 8);|
2. Polyposis syndromes;
3. History of inflammatory bowel disease;
4. Presence of conditions precluding histological sampling of the colon (e.g. coagulation disorders, anticoagulant therapy).
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||24-mrt-2011|
|- planned closingdate||24-feb-2012|
|- Target number of participants||205|
|- Primary outcome||1. The overall accuracy of the WavSTAT represented by the sensitivity and specificity using final histopathology as golden standard;|
2. The accuracy of the WavSTAT of lesions that are differentiated with white light endoscopy with low confidence, represented by the sensitivity and specificity using final histopathology as golden standard.
|- Secondary outcome||1. The percentage of lesions that is differentiated with white light endoscopy with high confidence;|
2. The difference between trainees and expert endoscopists regarding the percentage of lesions that is differentiated with high confidence with white light endoscopy;
3. The accuracy for predicting histopathology in lesions that are differentiated with high confidence with white light endoscopy;
4. The difference in accuracy between trainees and expert endoscopists for predicting histopathology in lesions that are differentiated with high confidence with white light endoscopy.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||MD, PhD Evelien Dekker|
|- CONTACT for SCIENTIFIC QUERIES||MD, PhD Evelien Dekker|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|SpectraScience, San Diego, CA, USA|
|- Brief summary||WavSTAT (Spectrascience, Inc., San Diego, CA, USA) is an optical biopsy system that can aide endoscopists in differentiation of colorectal lesions. Accurate differentiation of small colorectal lesions can result in removal of these lesions without formal histopathology making colonoscopy more efficient and cost-effective. |
The laser light of the WavSTAT is absorbed by colonic tissue resulting in an autofluorescent return signal, which is subsequently analysed. Within seconds a ‘non-adenomatous’ or ‘adenomatous’ result is displayed on a screen. The WavSTAT can be particularly useful as an add-on technique for differentiation of colorectal lesions that the endoscopist differentiates with low confidence using white light (WL).
The aim of the current study is to assess the sensitivity, specificity and accuracy of an algorithm combining WL and WavSTAT. In this algorithm, overall accuracy is defined by WL in high confidence lesions and by WavSTAT in low confidence lesions.
|- Main changes (audit trail)|
|- RECORD||2-jan-2012 - 29-jan-2012|