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Hyperplastic polyposis syndrome: Endoscopic treatment and surveillance.


- candidate number9120
- NTR NumberNTR2757
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-feb-2011
- Secondary IDs10.17.2005 METC AMC
- Public TitleHyperplastic polyposis syndrome: Endoscopic treatment and surveillance.
- Scientific TitleHyperplastic polyposis syndrome: Endoscopic treatment and surveillance.
- ACRONYMHPSB
- hypothesisTo prospectively assess the efficacy, feasibility and safety of a systemised endoscopic surveillance protocol in large multicentre HPS cohort.
- Healt Condition(s) or Problem(s) studiedColorectal cancer, Hyperplastic polyposis syndrome
- Inclusion criteriaHPS patients defined as:
> 5 HPs/SSA proximal to the sigmoid, of which 2 > 10 mm in diameter, or more than 20 HPs/SSAs distributed throughout the colon.
- Exclusion criteriaCarriers of a germline mutation in the MutYH or APC gene and individuals who have undergone a total colonic resection.
- mec approval receivedno
- multicenter trialyes
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jun-2010
- planned closingdate12-dec-2013
- Target number of participants125
- InterventionsData are collected in prospective manner from patients during a routine annual endoscopies with removal of all polyps < 3 mm.
- Primary outcomeTo prospectively assess the efficacy, feasibility and safety of a systemised endoscopic surveillance protocol in large multicentre HPS cohort.
- Secondary outcomeThe incidence of complications: The amount of polypectomies and the rate of protcol deviations and conversions to surgical resection will be assessed.
- Timepoints3 years.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Y. Hazewinkel
- CONTACT for SCIENTIFIC QUERIESMd PhD E. Dekker
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Dutch Cancer Society
- PublicationsN/A
- Brief summaryHyperplastic polyposis syndrome (HPS) is characterized by the presence of multiple colorectal serrated polyps and is associated with an increased colorectal cancer (CRC) risk. The prevalance of HPS is estimated to be 1:3000 which makes HPS more common than other polyposis syndromes such as FAP. Due to the risk of malignant polyp transformation, HPS patients undergo endscopic surveillance with removal of polyps or a surgical colonic resection. However, no uniform and adequately substantiated endoscopic management protcol exists regarding polyp removal and surveillance intervals.

Aim:
To prospectively assess the efficacy, feasibility and safety of a systemised endoscopic surveillance protocol in large multicentre HPS cohort.
- Main changes (audit trail)
- RECORD16-feb-2011 - 24-feb-2011


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