Multicentre Study of 10,369 Symptomatic Patients Comparing the Diagnostic Accuracy of Colon Capsule Endoscopy,...

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.

To evaluate the safety, diagnostic accuracy and utility of CCE in this setting.

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.

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.

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.