Adenomatous Polyp Clinical Trial
Official title:
Accuracy of Narrow Band Imaging in Predicting Colonoscopy Surveillance Intervals and Histology of Distal Diminutive Polyps (Small Hyperplastic and Adenomatous Reliability Protocol; SHARP Trial)
1. Protocol Summary Title: SHARP: Small Hyperplastic and Adenomatous Reliability Protocol
Purpose: To compare the accuracy of NBI-in vivo differentiation between hyperplastic and
adenomatous <10 mm polyps with that of histology in an European multi-center study. To
assess variability among endoscopists in NBI accuracy. We also aim to assess whether this
technology impacts the appropriateness of surveillance intervals.
Design: 1) Before starting the patient enrollment, the participating endoscopists will
attend an internet-based training program on the in vivo differentiation between
hyperplastic and adenomatous polyps. Following this course, a qualifying examination will be
required for each endoscopist to be included.
2) Patients who are scheduled for screening or diagnostic colonoscopy will be considered for
inclusion. Patients with at least one histologically verified <10 mm polyp will be included.
In order to measure NBI feasibility, each included polyp will be in vivo assessed by NBI in
order to rank between a high- and a low- level of diagnostic confidence, and thereafter will
be sent for histological assessment. NBI- and histological accuracy in differentiating
between hyperplastic and adenomatous lesions will be analyzed and compared, in order to
assess the NBI-sensitivity and specificity. The primary outcomes are to measure the NBI
feasibility and accuracy in the study population, and to assess the variability among the
endoscopists. Secondary outcome measures will be a cost analysis on how much savings would
be achieved by not referring NBI-diagnosed hyperplastic polyps to histology, and a clinical
inference on how many patients would be scheduled for an inappropriate post-polypectomy
follow up, when follow up schedule is based on NBI classification. Clinical results will be
analyzed using various statistical measures of significance.
Clinical Site Locations: 10 European centres with NBI-technology
1 NBI-expert endoscopist for each centre Enrollment: 160 small (<10 mm) polyps at each site
Study technology: NBI-Olympus without optical magnification Risk: Non-interventional study.
n/a
Observational Model: Cohort, Time Perspective: Cross-Sectional
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