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A Multicenter Comparison With Standard Colonoscopy for Detection of Colorectal Neoplasia

Peter B. Cotton, MD, FRCP, FRCS; Valerie L. Durkalski, PhD; Benoit C. Pineau, MD, MSc (Epid); Yuko Y. Palesch, PhD; Patrick D. Mauldin, PhD; Brenda Hoffman, MD; David J. Vining, MD; William C. Small, MD; John Affronti, MD, MS; Douglas Rex, MD; Kenyon K. Kopecky, MD; Susan Ackerman, MD; J. Steven Burdick, MD; Cecelia Brewington, MD; Mary A. Turner, MD; Alvin Zfass, MD; Andrew R. Wright, MBBS; Revathy B. Iyer, MD; Patrick Lynch, MD; Michael V. Sivak, MD; Harold Butler, MD

JAMA. 2004;291:1713-1719.

Context  Conventional colonoscopy is the best available method for detection of colorectal cancer; however, it is invasive and not without risk. Computed tomographic colonography (CTC), also known as virtual colonoscopy, has been reported to be reasonably accurate in the diagnosis of colorectal neoplasia in studies performed at expert centers.

Objective  To assess the accuracy of CTC in a large number of participants across multiple centers.

Design, Setting, and Participants  A nonrandomized, evaluator-blinded, noninferiority study design of 615 participants aged 50 years or older who were referred for routine, clinically indicated colonoscopy in 9 major hospital centers between April 17, 2000, and October 3, 2001. The CTC was performed by using multislice scanners immediately before standard colonoscopy; findings at colonoscopy were reported before and after segmental unblinding to the CTC results.

Main Outcome Measures  The sensitivity and specificity of CTC and conventional colonoscopy in detecting participants with lesions sized at least 6 mm. Secondary outcomes included detection of all lesions, detection of advanced lesions, possible technical confounders, participant preferences, and evidence for increasing accuracy with experience.

Results  A total of 827 lesions were detected in 308 of 600 participants who underwent both procedures; 104 participants had lesions sized at least 6 mm. The sensitivity of CTC for detecting participants with 1 or more lesions sized at least 6 mm was 39.0% (95% confidence interval [CI], 29.6%-48.4%) and for lesions sized at least 10 mm, it was 55.0% (95% CI, 39.9%-70.0%). These results were significantly lower than those for conventional colonoscopy, with sensitivities of 99.0% (95% CI, 97.1%->99.9%) and 100%, respectively. A total of 496 participants were without any lesion sized at least 6 mm. The specificity of CTC and conventional colonoscopy for detecting participants without any lesion sized at least 6 mm was 90.5% (95% CI, 87.9%-93.1%) and 100%, respectively, and without lesions sized at least 10 mm, 96.0% (95% CI, 94.3%-97.6%) and 100%, respectively. Computed tomographic colonography missed 2 of 8 cancers. The accuracy of CTC varied considerably between centers and did not improve as the study progressed. Participants expressed no clear preference for either technique.

Conclusions  Computed tomographic colonography by these methods is not yet ready for widespread clinical application. Techniques and training need to be improved.

Author Affiliations: Department of Gastroenterology (Drs Cotton and Hoffman) and Radiology (Dr Ackerman), The Digestive Disease Center, and Department of Pharmacy and Clinical Sciences (Dr Mauldin), and The Clinical Innovation Group (Drs Durkalski and Palesch), Medical University of South Carolina, Charleston; Departments of Gastroenterology (Dr Pineau) and Radiology (Dr Vining), Wake Forest University School of Medicine, Winston-Salem, NC; Departments of Radiology (Dr Small) and Gastroenterology (Dr Affronti), Emory University Hospital, Atlanta, Ga; Departments of Gastroenterology (Dr Rex) and Radiology (Dr Kopecky), Indiana University Hospital, Indianapolis; Departments of Gastroenterology (Dr Burdick) and Radiology (Dr Brewington), University of Texas Southwestern, Dallas; Departments of Radiology (Dr Turner) and Gastroenterology (Dr Zfass), Virginia Commonwealth University Medical Center, Medical College of Virginia, Richmond; Department of Radiology, St Mary's Hospital, London, England (Dr Wright); Departments of Radiology (Dr Iyer) and Gastroenterology (Dr Lynch), M. D. Anderson Cancer Center, Houston, Tex; Departments of Gastroenterology (Dr Sivak) and Radiology (Dr Butler), University Hospitals of Cleveland, Cleveland, Ohio.

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