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DOI: 10.1055/s-0039-1681645
COLON CAPSULE ENDOSCOPY WITH OR WITHOUT BIOMARKERS AS A VIABLE ALTERNATIVE TO COLONOSCOPY IN UNSELECTED PATIENTS WITH LOWER GI SYMPTOMS: RESULTS OF A PILOT STUDY
Publication History
Publication Date:
18 March 2019 (online)
Aims:
Lower-gastrointestinal symptoms (LGS) are poor at predicting Clinically-Significant Disease (CSD) despite being the main way of prioritising referrals. This has lead to prolonged wait-times with majority having normal colonoscopies. Alternative diagnostic pathways are needed; biomarkers and/or colon capsule endoscopy (CCE) may be helpful.
Aim:
To evaluate the use of stool biomarkers and CCE in diagnosing lower-GI disease compared to colonoscopy.
Methods:
A prospective comparative single-centre study. Following ethical approval, patients 18 – 80 years referred with LGS were recruited. Participants had FC, FIT, CCE and a standard colonoscopy. FIT> 10ug/g and FC> 50ug/g was considered positive. Colonoscopy was considered gold-standard. Diagnostic accuracy of biomarkers and CCE was determined and Pearson-coefficients calculated.
Results:
So far, 69 patients recruited; 8 excluded. Mean age 47 (20 – 79) years, 43%(n = 19) males. To date, 44/61 (72%) have undergone colonoscopy. Colonoscopy diagnostic yield 64%(n = 28); caecal intubation 95%(n = 41). Findings; diverticulosis 7 (16%), polyps 14 (30%), IBD 5 (11%), haemorrhoid 2 (5%). CSD 20%(9/44)-HRA 4 (9%), IBD 5 (11%).
40/44 (91%) FIT and 41/44 (93%) FC have been tested. 25%(n = 10) FIT and 41%(n = 13) FC were positive. Mean FIT = 14.2ug/g (range 0 – 149) and mean FC = 121.7ug/g (range < 19.5 – 168). FIT and FC has a weak correlation with colonoscopy (r = 0.1, -0.057 respectively). Combined FIT&FC positive (r = 0.08). Sensitivity, specificity, PPV and NPV; FIT 29%,81%,70%,43%; FC 32%,63%,57%,37%; combined 52%,56%,65%,43%.
CCE excretion rate 82%(n = 36/44) and reached left colon in 100%. Diagnostic yield for CCE was 61%(n = 27). CCE had a strong correlation with colonoscopy (R = 0.8). Polyp detection rate CCE, 39%(17/44) versus colonoscopy 32%(14/44).100%(9/9) CSD on colonoscopy was detected on CCE. Overall, CCE sensitivity = 90%, specificity = 93%, PPV = 95%, NPV = 92%. For CSD – sensitivity, specificity, PPV and NPV = 100%.
Conclusions:
Biomarkers performed poorly and should not be considered a reliable screening tool for CSD in patients with LGS. However, CCE had excellent correlation with colonoscopy in our unselected symptomatic cohort and warrants further investigation as a filter test.