Observational study;Confocal endomicroscopy in the diagnosis of colorectal neoplasia.
- Conditions
- 1. Colorectal cancer (coloncarcinoom)<br />2. adenomatous polyps (adenomateuze poliepen)<br />3. chromoendoscopy (chromoendoscopie)<br />4. confocal endomicroscopy (confocale endomicroscopie).<br />
- Registration Number
- NL-OMON29543
- Lead Sponsor
- Dr. S. Sanduleanu, gastroenterologistUniversity Hospital MaastrichtDepartment of Gastroenterology and HepatologyPO BOX 5800, 6202 AZMaastrichte-mail: sda@sint.azm.nltel: 0031-43-3875021
- Brief Summary
1. Confocal laser endomicroscopy: technical status and current indications. Endoscopy 2006;38(12):1275-83. Hoffman, A., Goetz, M., Vieth, M., Galle, P.R., Neurath, M.F., Kiesslich, R;<br> 2. Confocal laser endoscopy for diagnosing intraepithelial neoplasias and colorectal cancer in vivo. Gastroenterology 2004;127(3):706-13. Kiesslich, R., Burg, J., Vieth, M., Gnaendiger, J., Enders, M., Delaney, P., Polglase, A., McLaren, W., Janell, D., Thomas, S., Nafe, B., Galle, P.R., Neurath, M.F;<br> 3. The role of high-magnification-chromoscopic colonoscopy in hereditary nonpolyposis colorectal cancer screening: a prospective “back-to-back” endoscopic study.<br> Am J Gastroenterol 2005; 100:2167-73 Hurlstone, D.P., Karajeh, M., Cross, S.S., McAlindon, M.E., Brown, S., Hunter, M.D., Sanders, D.S.<br> cancer in vivo.<br> Gastroenterology 2004;127(3):706-13. Kiesslich, R., Burg, J., Vieth, M., Gnaendiger, J., Enders, M., Delaney, P., Polglase, A., McLaren, W., Janell, D., Thomas, S., Nafe, B., Galle, P.R., Neurath, M.F.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
1. Clinical diagnostic criteria for either HNPCC (Amsterdam II criteria , Bethesda criteria or genetic criteria) or familial colorectal cancer type X – (1) CRC diagnosed age < 50 years;
2. at least 2 first-degree relatives with CRC regardless of age;
1. Age < 18 years, presence of inflammatory bowel disease, or known polyposis syndromes;
2. Patients with incomplete endoscopic procedure due to anatomic or technique-related factors.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measure will be the number of patients with at least one adenoma after conventional colonoscopy compared with the number of patients with at least one adenoma after pan-chromoendoscopy.
- Secondary Outcome Measures
Name Time Method Secondary outcome measures assessing the diagnostic accuracy of combined pan-chromoendoscopy and confocal endomicroscopy are: total number of lesions detected; number of adenomas; number of advanced adenomas; number of flat lesions detected. <br><br>