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

Abstract

ObjectiveColon 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.DesignPatients 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.ResultsFrom 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.ConclusionCCE 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 numberClinicalTrials.gov no: NCT02754661.

Efficacy of bowel preparation regimens for colon capsule endoscopy: a systematic review and meta-analysis

“…The introduction of CCE as a filter examination in screening programs comes with the caveat that a high completion rate and adequate bowel cleanliness are prerequisite 66 67 . In a recent study by Cash et al comparing the DY of CCE versus computed tomography colography (CTC) in a screening population, CCE was superior to CTC for detection of polyps ≥ 6 mm but inferior to colonoscopy 68 . The CR and ACR of CCE should reach at least 90 % according to quality parameters for flexible colonoscopy defined by international guidelines 69 70 .…”

“…CI, confidence interval; OBS, observational study; PEG, polyethylene glycol; PEGAA, polyethylene glycol and ascorbic acid; RCT, randomized controlled trial. py [68]. The CR and ACR of CCE should reach at least 90 % according to quality parameters for flexible colonoscopy defined by international guidelines [69,70].…”

Patient-Reported Outcomes and Preferences for Colon Capsule Endoscopy and Colonoscopy: A Systematic Review with Meta-Analysis

“…Both examinations also require two stints of BP as the CCE report is not available immediately after excretion, enabling COC under same preparation. As BP is a documented barrier to COC and the increased cleansing regimen for CCE is a reason for preferring COC [22,32], the risk of double BP may tilt the preference towards COC, thereby playing an important role in the expression of PRO. As patient-reported procedural AE were very limited, they probably did not affect preference to a high degree, although the type of severe AE reported from COC (perforation) compared to CCE (capsule retention) is probably more likely to cause long-term effects.…”

“…After the removal of duplicates this was reduced to 1326 and, additionally, 1274 were excluded after title and abstract screening. Full text screening was performed for 52 references and 14 were eventually included in the study (Figure 1) [11,[18][19][20][21][22][23][24][25][26][27][28][29][30]. In 12 studies, participants had undergone both CCE and COC, and in two (n = 2) studies they were randomized for either.…”

“…eventually included in the study (Figure 1) [11,[18][19][20][21][22][23][24][25][26][27][28][29][30]. In 12 studies, participants had undergone both CCE and COC, and in two (n = 2) studies they were randomized for either.…”