Comparison of the efficiency of colon capsue endoscopy and optical colonoscopy in patients with positive immunochemical fecal occult blood test- multicenter prospective study
Abstract
Background: Fecal immunochemical tests havebeen used as an initial test in colorectal cancer screening programs. However, majority of patients don't have advanced neoplasia on colonoscopy.
Colon capsule endoscopy has the potential to reduce the need for optical colonoscopy. The main aim of the study was a negative predictive value of the second generation of colon capsule endoscopy for large polyps (>= 10 mm).
The secondary aims were: accuracy of detection of all polyps (polyps >= 6 mm and >= 10 mm) and cancers, the number of complications and target population acceptance of both methods (colon capsule endoscopy and optical colonoscopy). Material and methods: In this multicentre (three gastroenterology units) feasibility study, the second generation of colon capsule endoscopy (CCE2) has been prospectively compared with OC in persons with positive semi-quantitative FIT with cut-off level 75 ng/ml.
Colonoscopy was performed within 10 hours after capsule ingestion. CCE2 videos were viewed independently by a nurse and a physician, both blinded to the results of OC.
Complications were assessed as severe (bleeding, perforation) or mild to moderate. The methods of acceptance were evaluated based on the questionnaire completed after both procedures (CCE2 and OC) were finished.
The interim analysis of results is presented. Results: From April 2016, 167 individuals have been enrolled; data from 95 persons have been analyzed.
During the optical colonoscopy, polyps were diagnosed in 70 persons (74%), polyps >= 6 mm and >= 10 mm in 42 (44 %) and 26 (27 %) persons, respectively. The sensitivity of CCE2 for polyps >= 6 mm and >= 10 mm was 88 % (95% confidence interval [CI] 74-96 %) and 85 % (95% CI 65-96 %), respectively.
The specificity for polyps >= 6 mm and >= 10 mm reached 85 % (95% CI 72-93 %) and 93 % (95% CI 84-98 %), respectively. The negative predictive value of CCE2 for polyps >= 10 mm was 94 % (95% CI 86-98 %).
Nurses identified 36 polyps >= 6 mm of 42 (86 %) and 23 polyps >= 10 mm of 26 (88 %) found on OC. A total of 64 patients (68 %) preferred CCE2 as the primary screening method.
Conclusion: The second generation of colon capsule has appeared to have a high negative predictive value for the detection of clinically relevant colorectal neoplasia in a screening population. This method might be considered as an adequate tool for colorectal cancer screening.