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Endoscopic surveillance using narrow-band imaging in patients with hyperplastic polyposis syndrome (HPS): A multi-centre cohort study.


- candidate number8406
- NTR NumberNTR2497
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-sep-2010
- Secondary IDs10/160 METC AMC
- Public TitleEndoscopic surveillance using narrow-band imaging in patients with hyperplastic polyposis syndrome (HPS): A multi-centre cohort study.
- Scientific TitleEndoscopic surveillance using narrow-band imaging in patients with hyperplastic polyposis syndrome (HPS): A multi-centre cohort study.
- ACRONYMECLIPSE
- hypothesisHyperplastic polyposis syndrome (HPS) is characterized by the presence of multiple colorectal serrated polyps and co-existent conventional adenomas and is associated with an increased colorectal cancer (CRC) risk 1-9. Considering the presumed increased risk of malignant progression of polyps in HPS, detection and removal of polyps seems necessary to prevent CRC development in these patients. However, serrated polyps, which are the overall majority in HPS, are generally small in size, flat in shape and unremarkable in colour. These features are associated with polyp miss-rates of up to 26% using standard colonoscopy. Narrow-band imaging (NBI) may improve the detection and differentiation of these polyps.
- Healt Condition(s) or Problem(s) studiedNarrow band imaging, Hyperplastic polyposis syndrome
- Inclusion criteriaAll HPS patients, defined as having:
1. ≥5 HPs/SSAs proximal to the sigmoid colon of which 2 are greater than 10mm in diameter or;
2. ≥20 HPs/SSAs spread throughout the colon.
- Exclusion criteria1. Patients carrying a germline mutation in the MutYH (biallelic) or APC gene and individuals who have undergone a total colonic resection;
2. History of inflammatory bowel disease;
3. Severe coagulopathy;
4. Age less than 18 years and;
5. Insufficient bowel preparation (<90% of colonic mucosa visible).
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2010
- planned closingdate31-dec-2011
- Target number of participants52
- InterventionsAll patients will undergo tandem colonoscopy with HRE and NBI, in randomized order with removal of all detected polyps ≥3 mm after characterization for Kudo pit pattern and vascular pattern intensity (VPI).
- Primary outcomePolyp miss-rates of NBI vs. HRE.
- Secondary outcomeThe diagnostic accuracy of NBI-VPI vs. HRE-VPI for the differentiation of polyps.
- Timepoints1. Inclusion: october 2010- end 2011;
2. Data analysis: december 2011.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Y. Hazewinkel
- CONTACT for SCIENTIFIC QUERIES Y. Hazewinkel
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD3-sep-2010 - 4-mei-2012


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