Original articleAlimentary tractEndoscopic Detection of Proximal Serrated Lesions and Pathologic Identification of Sessile Serrated Adenomas/Polyps Vary on the Basis of Center
Section snippets
Setting
The current study represents a secondary analysis of the prospective, multicenter clinical trial evaluating methylated Septin9 for the detection of CRC in an average-risk screening population (NCT00855348 Number: ClinicalTrials.gov). All authors had access to the study data and reviewed and approved the final manuscript. The study, Prospective Evaluation of Septin 9 (PRESEPT), prospectively enrolled subjects in 22 sites in the United States and 10 in Germany.20 There were 3 academic centers in
Results
A total of 7215 screening colonoscopies were performed at 32 endoscopy centers during the course of the nearly 2-year study. There were 22 U.S. centers that recruited 76% of all subjects, and 10 German centers recruited 24% of subjects. Overall, mean age was 60.5 ± 7.6 years, and 45% of subjects were male. A total of 5778 lesions were detected in 3247 subjects, of which 3008 (52.1%) were conventional adenomas, and 350 (6.1%) were serrated lesions as defined for this study (SSA/P, SSA with
Discussion
This multicenter study shows that in a screening cohort, the proportion of subjects with at least 1 proximal serrated lesion (defined as SSA/P or a hyperplastic polyp ≥10 mm in size) was 2.8%, with a range of 0%–9.8% between centers. These findings are in agreement with prior studies demonstrating variable detection between individual examiners,18, 19 although the definition of serrated lesion in earlier studies also included hyperplastic lesions <10 mm. This is a demonstration of variable
Acknowledgments
Theo DeVos and Thomas Konig of Epigenomics, Inc, participated in statistical analysis and revision of the manuscript.
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Conflicts of interest These authors disclose the following: S. Payne was an employee of Epigenomics when the study was initiated. T. Church's institution received from Epigenomics for the original PRESEPT study a grant, travel support, and fees for participation in review activities and payment for writing or reviewing the original PRESEPT manuscript. M. Wandell was an employee of Epigenomics when the study was initiated. D. Snover received travel support and fees for slide review in the original PRESEPT study. R. Day is a paid consultant to Epigenomics. D. Rex is a member of the Epigenomics Scientific Advisory Board. The remaining authors disclose no conflicts.
Epigenomics initiated and conducted the PRESEPT study. The colonoscopies performed in that study are the basis for the current study. The study sponsor provided statistical support, and Theo DeVos participated in revision of the manuscript. Shannon Payne was an employee of Epigenomics, supervised the initial analyses, and wrote the first draft of the manuscript during her employment by Epigenomics.