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Video Autofluorescence Imaging for Detection of Adenomatous Polyps of the colon in Intermediate and High-risk Patients.


- candidate number1837
- NTR NumberNTR521
- ISRCTNISRCTN76121851
- Date ISRCTN created22-jan-2007
- date ISRCTN requested12-jan-2007
- Date Registered NTR18-nov-2005
- Secondary IDsN/A 
- Public TitleVideo Autofluorescence Imaging for Detection of Adenomatous Polyps of the colon in Intermediate and High-risk Patients.
- Scientific TitleVideo Autofluorescence Imaging for Detection of Adenomatous Polyps of the colon in Intermediate and High-risk Patients.
- ACRONYMPOLPAN study
- hypothesisThe aims of the study are:
1. to assess the clinical utility and feasibility of AFI surveillance colonoscopy in patients with intermediate or high risk for adenomatous polyps;
2. to determine the additional value of AFI in the detection of polyps in these patients;
3. to characterize the pit-patterns in the different polyps using NBI.
- Healt Condition(s) or Problem(s) studiedCancer, Polyps
- Inclusion criteria1. Previous adenomatous polyp (polyp-surveillance);
2. Previous adenocarcinoma of the colon for which a partial colectomy was performed;
3. Hereditary non-polyposis colorectal cancer (either genetically proven by a mutation in one of the mismatch repair genes or with a clinical diagnosis according to the Amsterdam II criteria [14]);
4. Positive family history for CRC: a first-degree family-member fullfills one of the revised Bethesda criteria.
- Exclusion criteria1. Familiar adenomatous polyposis;
2. History of inflammatory bowel disease;
3. Severe coagulopathy;
4. Age less than 18 years.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2005
- planned closingdate1-dec-2006
- Target number of participants100
- InterventionsHigh resolution white light endoscopy versus Autofluorescence endoscopy.
- Primary outcomeThe sensitivity of high resolution white light endoscopy will be compared to that of AFI for detection of polyps and cancer in the colon.
- Secondary outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD, PhD Evelien Dekker
- CONTACT for SCIENTIFIC QUERIESMD, PhD Evelien Dekker
- Sponsor/Initiator Academic Medical Center (AMC), Department of Gastroenterology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryAn endoscopic video autofluorescence imaging study for detection of Adenomatous Polyps of the colon with patients ad an intermediate and high risk of adenomatous polyps.
- Main changes (audit trail)
- RECORD18-nov-2005 - 14-sep-2009


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