Gastroenterology

Gastroenterology

Volume 148, Issue 5, May 2015, Pages 948-957.e2
Gastroenterology

Original Research
Full Report: Clinical—Alimentary Tract
Accuracy of Capsule Colonoscopy in Detecting Colorectal Polyps in a Screening Population

https://doi.org/10.1053/j.gastro.2015.01.025Get rights and content

Background & Aims

Capsule colonoscopy is a minimally invasive imaging method. We measured the accuracy of this technology in detecting polyps 6 mm or larger in an average-risk screening population.

Methods

In a prospective study, asymptomatic subjects (n = 884) underwent capsule colonoscopy followed by conventional colonoscopy (the reference) several weeks later, with an endoscopist blinded to capsule results, at 10 centers in the United States and 6 centers in Israel from June 2011 through April 2012. An unblinded colonoscopy was performed on subjects found to have lesions 6 mm or larger by capsule but not conventional colonoscopy.

Results

Among the 884 subjects enrolled, 695 (79%) were included in the analysis of capsule performance for all polyps. There were 77 exclusions (9%) for inadequate cleansing and whole-colon capsule transit time fewer than 40 minutes, 45 exclusions (5%) before capsule ingestion, 15 exclusions (2%) after ingestion and before colonoscopy, and 15 exclusions (2%) for site termination. Capsule colonoscopy identified subjects with 1 or more polyps 6 mm or larger with 81% sensitivity (95% confidence interval [CI], 77%−84%) and 93% specificity (95% CI, 91%–95%), and polyps 10 mm or larger with 80% sensitivity (95% CI, 74%−86%) and 97% specificity (95% CI, 96%–98%). Capsule colonoscopy identified subjects with 1 or more conventional adenomas 6 mm or larger with 88% sensitivity (95% CI, 82%−93) and 82% specificity (95% CI, 80%–83%), and 10 mm or larger with 92% sensitivity (95% CI, 82%–97%) and 95% specificity (95% CI, 94%–95%). Sessile serrated polyps and hyperplastic polyps accounted for 26% and 37%, respectively, of false-negative findings from capsule analyses.

Conclusions

In an average-risk screening population, technically adequate capsule colonoscopy identified individuals with 1 or more conventional adenomas 6 mm or larger with 88% sensitivity and 82% specificity. Capsule performance seems adequate for patients who cannot undergo colonoscopy or who had incomplete colonoscopies. Additional studies are needed to improve capsule detection of serrated lesions. Clinicaltrials.gov number: NCT01372878.

Section snippets

Equipment and Study End Points

The PillCam COLON 2 (Given Imaging Inc, Yoqneam, Israel) capsule was used in this study. The PillCam COLON 2 system includes the second-generation ingestible capsule, sensors attached to the abdomen that receive capsule images, a data recorder, and a software package that displays the images on a workstation and can create procedure reports.

The primary end point of this prospective study was the accuracy (sensitivity and specificity) of the PillCam COLON 2 for detecting patients with polyps 6

Exclusions

Figure 1 diagrams the initial enrollment cohort to the final analysis cohort. Of 884 asymptomatic subjects enrolled, 695 were included in the analysis of all polyps. Six patients did not have a pathology report, therefore 689 were included in the adenoma analysis. The mean age of the 689 subjects was 57 years, and 56% were female.

There were 77 subjects (9%) excluded for both inadequate cleansing and whole-colon transit time fewer than 40 minutes. Forty-five subjects dropped out before the

Discussion

This report describes a capsule endoscopy study for colorectal polyp detection in asymptomatic persons.

Several aspects of the study design and the results of this trial are important to consider because they indicate that a complete understanding of capsule performance relative to colonoscopy is difficult to achieve. First, polyps were matched by colon segment whereas in previous trials of the second-generation capsule polyps were matched by the entire colon.2, 3 When we performed a secondary

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    Conflicts of interest These authors disclose the following: Douglas Rex and Samuel Adler have received consulting fees from Given Imaging, Inc; Cristina Carretero has received speaker’s fees and fees for central reading from Given Imaging, Inc; Ignacio Fernandez-Urien Sainz, Wai-Keung Leung, Neofytos Papageorgiou, and Matti Waterman have received fees for central reading from Given Imaging, Inc.

    Given Imaging, Inc, participated in the study design, provided funding, participated in data analysis, review, and comment on the manuscript.

    The remaining authors disclose no conflicts.

    Funding Supported by Given Imaging, Inc.

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