Multicentre, prospective, randomised study comparing the diagnostic yield of colon capsule endoscopy versus CT colonography in a screening population (the TOPAZ study).

结肠镜检查 放射科 结直肠癌 内科学 前瞻性队列研究 肠道准备 钡灌肠 乙状结肠镜检查 内窥镜检查 虚拟大肠镜
作者
Brooks D. Cash,Mark R Fleisher,Steven Fern,Elizabeth Rajan,Robyn Haithcock,David Kastenberg,David Pound,Neofytos P. Papageorgiou,Ignacio Fernandez-Urien,Ira Schmelkin,Douglas K. Rex
出处
期刊:Gut [BMJ]
卷期号:70 (11): 2115-2122 被引量:12
标识
DOI:10.1136/gutjnl-2020-322578
摘要

Objective Colon capsule endoscopy (CCE) has shown promise for colorectal neoplasia detection compared with optical colonoscopy (OC), but has not been compared with other screening tests in average risk screening patients. Design Patients 50 to 75 years of age (African Americans, 45–75 years) were randomised to CCE or CT colonography (CTC) and subsequent blinded OC. The primary endpoint was diagnostic yield of polyps ≥6 mm with CCE or CTC. Secondary endpoints included accuracy for size and histology, examination completeness, number/proportion of subjects with polyps and adenomas ≥6 mm and ≥10 mm, subject satisfaction and safety. Results From 320 enrolled subjects, data from 286 (89.4%) were evaluable. The proportion of subjects with any polyp ≥6 mm confirmed by OC was 31.6% for CCE versus 8.6% for CTC (pPr non-inferiority and superiority=0.999). The diagnostic yield of polyps ≥10 mm was 13.5% with CCE versus 6.3% with CTC (pPr non-inferiority=0.9954). The sensitivity and specificity of CCE for polyps ≥6 mm was 79.2% and 96.3% while that of CTC was 26.8% and 98.9%. The sensitivity and specificity of CCE for polyps ≥10 mm was 85.7% and 98.2% compared with 50% and 99.1% for CTC. Both tests were well tolerated/safe. Conclusion CCE was superior to CTC for detection of polyps ≥6 mm and non-inferior for identification of polyps ≥10 mm. CCE should be considered comparable or superior to CTC as a colorectal neoplasia screening test, although neither test is as effective as OC. Trial registration number ClinicalTrials.gov no: NCT02754661.
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