Multicentre Study of 10,369 Symptomatic Patients Comparing the Diagnostic Accuracy of Colon Capsule Endoscopy, Colonoscopy and CT Colonography

Abstract

Background: During the COVID-19 pandemic, NHS England introduced colon capsule endoscopy (CCE) at scale to support the recovery of endoscopy. Symptomatic patients referred with suspected colorectal cancer (CRC) and a faecal immunochemical test (FIT) ≤ 100 μg Hb/g faeces were offered CCE. Aims: To evaluate the safety, diagnostic accuracy and utility of CCE in this setting. Methods: Consenting patients, referred on a suspected CRC pathway with FIT ≤ 100 μg Hb/g faeces, were offered CCE, colonoscopy or CT colonography. Each cohort was to be age-, sex-, symptom- and FIT-matched. We performed a paired comparison of findings in those who required colorectal endoscopy after CCE and recorded clinical outcomes. Results: We recruited 4878 patients for CCE, 5025 for colonoscopy and 466 for CT colonography patients. CCE was safely tolerated by 98.4% of patients. CCE identified a matched mass lesion in all patients with CRC when the examination was complete and adequately prepared. More polyps ≥ 10 mm and 6–9 mm were detected by CCE than by colonoscopy or CT colonography. Per-patient sensitivities for polyps ≥ 10 mm and 6–9 mm were 97% in those with a paired, complete and adequately prepared CCE than colonoscopy. Completion (74%) and bowel preparation adequacy rates (74%) were poorer than those of colonoscopy and CTC (both 88%). However, CCE usefully performed a filter function in 86% of patients. Conclusions: CCE is safe and accurate for the diagnosis of colorectal disease. In the suspected CRC pathway, its ‘filter function’ complements existing colorectal diagnostic services by creating additional capacity.