No registrations found.
ID
Source
Brief title
Health condition
Hyperplastic
Polyposis
Syndrome
Narrow Band Imaging
Sponsors and support
Intervention
Outcome measures
Primary outcome
Polyp miss-rates of NBI vs. HRE.
Secondary outcome
The diagnostic accuracy of NBI-VPI vs. HRE-VPI for the differentiation of polyps.
Background summary
N/A
Study objective
Hyperplastic 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.
Study design
1. Inclusion: october 2010- end 2011;
2. Data analysis: december 2011.
Intervention
All 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).
Y. Hazewinkel
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5662806
y.hazewinkel@amc.uva.nl
Y. Hazewinkel
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5662806
y.hazewinkel@amc.uva.nl
Inclusion criteria
All 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 criteria
1. 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).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2390 |
| NTR-old | NTR2497 |
| Other | METC AMC : 10/160 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |