THE COMPARISON OF THE EFFICIENCY OF COLON CAPSULE ENDOSCOPY AND OPTICAL COLONOSCOPY IN PATIENTS WITH POSITIVE IMMUNOCHEMICAL FECAL OCCULT BLOOD TEST: MULTICENTER, PROSPECTIVE STUDY

Aims:

The main aim of the study was a negative predictive value (NPV) of the second generation of colon capsule endoscopy (CCE2) for large polyps (≥10 mm). The secondary aims were: accuracy of detection of polyps ≥6 mm and ≥10 mm, complications and target population acceptance of CCE2 and optical colonoscopy (OC).

Methods:

In this multicenter feasibility study, the second generation of colon capsule endoscopy (CCE2) has been prospectively compared with OC in persons with positive FIT with cut-off level 75 ng/ml. CCE2 videos were viewed independently by a nurse and a physician, both blinded to the results of OC. The methods of acceptance were evaluated based on the questionnaire completed after CCE2 and OC were finished.

Results:

From April 2016, 200 individuals have been enrolled; data from 105 persons have been analyzed. During the optical colonoscopy, polyps were diagnosed in 79 persons (75%), polyps ≥6 mm and ≥10 mm in 47 (45%) and 29 (28%) persons, respectively. The sensitivity of CCE2 for polyps ≥6 mm and ≥10 mm was 87% (95% confidence interval [CI]: 74 – 95%) and 83% (95% CI: 64 – 94%), respectively. The specificity for polyps ≥6 mm and ≥10 mm reached 84% (95% CI: 73 – 93%) and 91% (95% CI: 82 – 96%), respectively. The negative predictive value of CCE2 for polyps ≥10 mm was 93% (95% CI: 85 – 98%). Nurses identified 40 polyps ≥6 mm of 47 (85%) and 25 polyps ≥10 mm of 29 (86%) found on OC. A total of 69 patients (66%) preferred CCE2 as the primary screening method.

Conclusions:

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.