Abstract
INTRODUCTION: Colonoscopy is the gold standard in detection of malignant and premalignant colon polyps. It is estimated that missed adenomas account for 50% of interval colorectal cancers. Different adjunctive modalities and devices have been trialed, including external caps on the tip of the endoscope to improve fields of view. There is conflicting evidence of cap-assisted colonoscopy and benefit of adenoma detection among the average risk population. Given the lack of consensus regarding the overall benefit of cap-assisted colonoscopy, our study aimed to compare the adenoma detection rate with AmplifEYE™-assisted colonoscopy versus standard colonoscopy in high-risk patients that require surveillance colonoscopy. METHODS: This was a single center, prospective, randomized controlled study testing adenoma detection of the AmplifEYE™ Endoscopy Device among high-risk patients undergoing surveillance colonoscopy. Informed written consent was obtained prior to randomization and colonoscopy. Patients were randomized to either the AmplifEYE™ or the standard colonoscopy control group. Demographic data, colonoscopy procedure and pathology reports, and colonoscopy preparation data were collected and analyzed. Data collection started in October of 2019 and is currently ongoing. Univariate analysis was performed. RESULTS: At time of analysis, 18 patients were randomized to the control group and 17 patients were randomized to the AmplifEYE™ group. The control group and AmplifEYE™ group had a median age of 68 and 59 years of age, respectively (P = 0.0216). No sex or race differences were detected. No colonoscopy timing differences were found relating to insertion time to cecum (6 vs. 7 min; P = 0.2290), withdrawal time (8 vs. 10 min; P = 0.2551), or total procedure time (15 vs. 17 min; P = 0.2974) among either group. No differences were found in polyp detection (56% vs. 47%; P = 0.6152). No diminutive polyps were detected in the AmplifEYE™ group. No correlation was observed between polyp location or pathology among the two groups (Table 1). CONCLUSION: The AmplifEYE™-assisted colonoscopy did not show superiority to a standard colonoscopy in regards to polyp detection. The AmplifEYE™ device group did not detect any diminutive polyps which raises concerns about polyp detection effectiveness, however, population size is a limiting factor. More data needs to be collected to detect procedure length differences or if polyp detection rates are correlated. Data collection is currently ongoing and will conclude in October of 2020.Table 1
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