Yutaka Saito, MD, PhD, from the Endoscopy Division at the National Cancer Center Hospital in Tokyo, Japan discusses this Original Article, “Evaluation of the clinical efficacy of colon capsule endoscopy in the detection of lesions of the colon: prospective, multicenter, open study.”

The aims of this study were to evaluate the sensitivity of colon capsule endoscopy (CCE) in detecting polyps and other lesions compared with optical colonoscopy (OC) and its safety and acceptability in a cohort of Japanese patients by a prospective, multi-center, open-label clinical study. The primary endpoint was per-patient sensitivity of CCE in detecting any colonic lesion. The secondary endpoints were CCE safety and patient acceptability.

Japanese endoscopists pay significant attention to detection of not only polypoid tumors but also flat or depressed tumors in the setting of good bowel preparation. Therefore, it is important to compare CCE sensitivity with OC as the current gold standard for polyp detection in a Japanese cohort of patients.  Secondly, OC still has the potential to miss significant tumors, making it is important to calculate the per-polyp sensitivity in CCE, which has not been reported to date. Thirdly, CCE safety and patient acceptability are quite important, yet no prospective study has evaluated this.

This trial demonstrates that CCE with a reduced preparation regimen was safe with a sensitivity of 94% for detecting significant lesions, including laterally spreading tumors (LSTs). Until now, there has been limited information on the accuracy of CCE for flat lesions, which are important contributors to the development of colorectal cancer. CCE scored highly acceptable in the subjective assessment of CCE acceptability. Therefore, CCEmay contribute an increase in the compliance rate of colorectal cancer screening. This study was the first to calculate per-polyp sensitivity, which was 86.7% (95%CI: 81.4-92.0%) when pathologically confirmed polyps were considered true positives.

The limitations of our study were as follows:

This clinical trial included subjects with previously confirmed significant lesions making it impossible to evaluate the specificity of CCE. However, previous reports describe a specificity ranging from 64-94%. Additionally, CCE detected a greater number of lesions than the first OC. The exceptionally high sensitivity of CCE in this study may have been affected by a potential bias, as the study was designed to evaluate patients with at least one known significant lesion. However, the reader did not know the location, the number, or the macroscopic type of the lesions. Capsule endoscopy may have a clinical benefit for patients with at least one significant lesion that requires endoscopic treatment.

Read the abstract of this article here.

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