Abstract
PURPOSE: Small bowel (SB) capsule endoscopy (CE) is a well-established investigation for suspected SB pathology, but little research has evaluated the diagnostic miss rate of SB cancer. This Australian study sought to assess the risk of developing SB cancer within 36 months of a cancer-negative CE (PCSBC-3Y) using a novel root-cause analysis (RCA) method. METHODS: Using a prospective CE database and data linkage with a population-based state cancer registry, the PCSBC-3Y rate was evaluated in consecutive patients undergoing CE between 2007 and 2019. SB cancers diagnosed or suspected from CE were defined as 'detected cancers', whilst those diagnosed within 36 months of a negative CE were defined as 'missed cancers'. Descriptive statistics summarised characteristics for all diagnosed SB cancers. All PCSBC-3Y cases were evaluated by RCA. RESULTS: A total of 20 patients were diagnosed with SB cancer within 36 months of CE, comprising of 18 detected cancers and two missed cancers. The overall PCSBC-3Y rate was 10% (95% CI 2.6-28.7%). The two missed cancers included one jejunal gastrointestinal stromal tumour and one duodenal adenocarcinoma. RCA revealed both missed cancers to be unavoidable, as the SB was normal on two retrospective reviews of the CE video recordings. CONCLUSION: This study introduces the concept of measuring the PCSBC-3Y rate and a novel algorithm of RCA. In our quaternary referral CE cohort, the PCSBC-3Y rate was 10%. A subsequent RCA suggested that the two missed cancers were unavoidable.