Combined pan-chromoendoscopy and confocal endomicroscopy for the diagnosis of colorectal neoplasia in subjects at high-risk for colorectal cancer
Completed
- Conditions
- familial colorectal cancer1001801810017934
- Registration Number
- NL-OMON31853
- Lead Sponsor
- Academisch Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
60 asymptomatic patienten, fulfilling the clinical diagnostic criteria for either HNPCC (Amsterdam II criteria, Bethesda criteria or genetic criteria) or familial colorectal cancer type X * ( i) CRC diagnosed age < 50 years or ii) at least 2 first-degree relatives with CRC regardless of age or iii) 1 first-degree and 1 second-degree relative with CRC regardless of age) - will be included.
Exclusion Criteria
The following exclusion criteria will be used: age < 18 years, presence of inflammatory bowel disease, or known polyposis syndromes. Also, patients with incomplete endoscopic procedure due to anatomic or technique-related factors will not be included.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome measure will be the number of patients with at least one<br /><br>adenoma after conventional colonoscopy compared with the number of patients<br /><br>with at least one adenoma after pan-chromoendoscopy-guided endomicroscopy. We<br /><br>presume that 10-28% of the participants will have at least one adenoma after<br /><br>conventional colonoscopy. For a power (1-b) of 80% to detect a 100% increase in<br /><br>the number of patients with at least one adenoma after pan-chromoendoscopy<br /><br>(assuming an adenoma prevalence of 10%), with a significance level (a) of 5%,<br /><br>at least 60 patients need to be included. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measures assessing the diagnostic accuracy of combined<br /><br>pan-chromoendoscopy and confocal endomicroscopy as compared to conventional<br /><br>colonoscopy with biopsies are: total number of lesions detected; number of flat<br /><br>lesions, number of adenomas; number of advanced adenomas detected. </p><br>