|- candidate number||7888|
|- NTR Number||NTR2265|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-mrt-2010|
|- Secondary IDs||MEC 09-2-96 METC MUMC|
|- Public Title||Standard versus high definition colonoscopy.|
|- Scientific Title||Standard colonoscopy versus high-definition colonoscopy (HD) with/without I-scan functions in the detection of colorectal neoplasia: a randomized multicenter study.|
|- hypothesis||Assess of the effect of HD colonoscopy alone or when combined with different I-scan functions compared to standard colonoscopy with respect to adenoma detection rate.|
|- Healt Condition(s) or Problem(s) studied||Adenomas, Colonoscopy, Screening|
|- Inclusion criteria||A. One of the following reasons for colonoscopy: |
1. Abdominal complaints;
2. Chronic diarrhea;
3. Iron deficiency anemia/ positive fecal occult blood test;
4. (Family) history of adenomatous polyps of colorectal cancer;
5. Screening colonoscopy to prevent CRC.
B. Sex: both males and females;
C. Age: above 40 years.
|- Exclusion criteria||1. Previous extended colon surgery;|
2. Inflammatory bowel disease (IBD);
3. Hereditary polyposis syndromes;
4. Known gastrointestinal neoplasia before endoscopy (based on recent endoscopy or other imaging like CT).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2010|
|- planned closingdate||1-apr-2011|
|- Target number of participants||1472|
|- Interventions||1. Group A: Standard colonoscopes;|
2. Group B: HD colonoscopes;
3. Group C: HD colonoscopes and I-scan Surface Enhancement (SE) (level 4);
4. Group D: HD colonoscopes and I-scan Surface Enhancement (SE) (level 4) and I-scan Colon Mode.
|- Primary outcome||Adenoma detection rate (ADR): The total number of adenomatous lesions (histological proven) divided by the number of patients per arm in all four groups.|
|- Secondary outcome||1. The total number of polyps (adenomatous polyps, hyperplastic polyps, serrated adenomas and inflammatory polyps);|
2. The total number and percentage of non-polypoid or flat adenomas (Paris classification 0-IIa-c);
3. Proportion of patients with adenoma;
4. Proportion of patients with more than one polyp;
5. The total number and percentage of small polypoid (< 5mm) or flat lesions (height < ½ diameter);
6. The total number of advanced adenoma defined as adenoma with high grade dysplasia, villous components, intramucosal carcinoma and angio-invasive growth;
7. Number of missed lesions. This will be assessed after a follow up period of 60 months. Patients will be asked by a questionnaire whether they have had any colonoscopy within 60 months of the study period and if so, if any (pre)malignant lesions are found.
|- Timepoints||1. Single colonoscopy;|
2. Questionaire after 60 weeks.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MD. R.J.J. Ridder, de|
|- CONTACT for SCIENTIFIC QUERIES||MD. R.J.J. Ridder, de|
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|Maastricht University Medical Center (MUMC+)|
|- Brief summary||Adenomatous polyps are precursors for colorectal cancer. Colonoscopy is considered to be the golden standard for the detection of colonic neoplasia. In theory, colon cancer can be prevented by removing all adenomatous polyps. However, there is a significant number of missed lesions, as assessed by back-to-back colonoscopy. This mis-rate can be attributed to lack of technique (short withdrawal time, insufficient bowel preparation) or due to technological causes like the quality of endoscopes to visualise small lesions and the possibility to look behind folds. Several technological innovations in both colonoscope design, performances and image processing are tested to improve colon visualisation and to lower the number of missed lesions. Data of studies regarding the effect on adenoma detection rate (ADR) by use of high definition (HD) endoscopes compared to standard colonoscopes are conflicting. This may result from differences in expertise of endoscopists, types of endoscopes and software applications. The ADR is the most frequently used primary outcome parameter with respect of screening of colorectal neoplasia and as indicator of quality assessment.
Recently, Pentax developed a digital mucosal enhancement function, called I-scan. This function is incorporated into Pentax HD colonoscopes. These endoscopes have the highest resolution available in flexible endoscopy nowadays. Several function modes are available for the enhancement of vessel structures and pit pattern. The mode that enhances the mucosal vessel architecture, thereby improving of detection of small mucosal lesions is called Surface Enhancement. Digital image processing with emphasis on certain wavelengths of white light like the Colon Mode will probably add additional mucosal and vascular details. The present study is designed to assess the effect of HD colonoscopy alone or when combined with different I-scan functions compared to standard colonoscopy with respect to adenoma detection rate.
|- Main changes (audit trail)|
|- RECORD||30-mrt-2010 - 9-apr-2010|