Second-generation colon capsule endoscopy compared with colonoscopy - 27/08/11

Doi : 10.1016/j.gie.2011.03.1125

Cristiano Spada, MD ^a,^⁎, Cesare Hassan, MD, PhD ^a, Miguel Munoz-Navas, MD, PhD ^b, Horst Neuhaus, MD ^c, Jacques Deviere, MD, PhD ^d, Paul Fockens, MD, PhD, FASGE ^e, Emmanuel Coron, MD, PhD ^f, Gerard Gay, MD ^g, Ervin Toth, MD, PhD ^h, Maria Elena Riccioni, MD, PhD ^a, Cristina Carretero, MD ^b, Jean P. Charton, MD ^c, Andrè Van Gossum, MD, PhD ^d, Carolien A. Wientjes, MD ^e, Sylvie Sacher-Huvelin, MD ^f, Michel Delvaux, MD, PhD ^g, Artur Nemeth, MD ^h, Lucio Petruzziello, MD ^a, Cesar Prieto de Frias, MD ^b, Rupert Mayershofer, MD ^c, Leila Aminejab, MD ^d, Evelien Dekker, MD, PhD ^e, Jean-Paul Galmiche, MD, FRCP ^f, Muriel Frederic, MD ^g, Gabriele Wurm Johansson, MD, PhD ^h, Paola Cesaro, MD ^a, Guido Costamagna, MD, FACG ^a
^a Digestive Endoscopy Unit, Catholic University, Rome, Italy
^b Gastroenterology Department, University of Navarra Clinic, Pamplona, Spain
^c Department of Internal Medicine, Evangelisches Krankenhaus, Düsseldorf, Germany
^d Department of Gastroenterology, Hopital Erasme, Université Libre de Bruxelles, Brussels, Belgium
^e Department of Gastroenterology and Hepatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
^f Department of Gastroenterology and Hepatology, University Hospital, Nantes, France
^g Department of Internal Medicine and Digestive Pathology, Hopitaux de Brabois, University Hospital of Nancy, Vandoeuvre les Nancy, France
^h Endoscopy Unit, Skåne University Hospital, Malmö, Sweden

Reprint requests: Cristiano Spada, MD, Digestive Endoscopy Unit, Catholic University, Largo F. Vito 1, 00168 Rome, Italy

Résumé

Background

Colon capsule endoscopy (CCE) represents a noninvasive technology that allows visualization of the colon without requiring sedation and air insufflation. A second-generation colon capsule endoscopy system (PillCam Colon 2) (CCE-2) was developed to increase sensitivity for colorectal polyp detection compared with the first-generation system.

Objective

To assess the feasibility, accuracy, and safety of CCE-2 in a head-to-head comparison with colonoscopy.

Design and Setting

Prospective, multicenter trial including 8 European sites.

Patients

This study involved 117 patients (mean age 60 years). Data from 109 patients were analyzed.

Intervention

CCE-2 was prospectively compared with conventional colonoscopy as the criterion standard for the detection of colorectal polyps that are ≥6 mm or masses in a cohort of patients at average or increased risk of colorectal neoplasia. Colonoscopy was independently performed within 10 hours after capsule ingestion or on the next day.

Main Outcome Measurements

CCE-2 sensitivity and specificity for detecting patients with polyps ≥6 mm and ≥10 mm were assessed. Capsule-positive but colonoscopy-negative cases were counted as false positive. Capsule excretion rate, level of bowel preparation, and rate of adverse events also were assessed.

Results

Per-patient CCE-2 sensitivity for polyps ≥6 mm and ≥10 mm was 84% and 88%, with specificities of 64% and 95%, respectively. All 3 invasive carcinomas were detected by CCE-2. The capsule excretion rate was 88% within 10 hours. Overall colon cleanliness for CCE-2 was adequate in 81% of patients.

Limitations

Not unblinding the CCE-2 results at colonoscopy; heterogenous patient population; nonconsecutive patients.

Conclusion

In this European, multicenter study, CCE-2 appeared to have a high sensitivity for the detection of clinically relevant polypoid lesions, and it might be considered an adequate tool for colorectal imaging.

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Abbreviations : CCE-2, PEG

Plan

Patients and methods

Second-generation colon capsule endoscopy

Colonoscopy

Statistical methods

Results

Colon cleansing level

Colon capsule endoscopy egestion rate

Colon capsule endoscopy accuracy

Adverse events

Discussion

	DISCLOSURE: C. Spada, C. Hassan, H. Neuhaus, J. Deviere, A. Van Gossum, S. Sacher-Huvelin, J-P Galmiche, and G. Costamagna are speakers for Given Imaging Ltd. J. Deviere, J-P Galmiche, and G. Costamagna have received research grants from Given Imaging Ltd. No other financial relationships relevant to this publication were disclosed.
	If you would like to chat with an author of this article, you may contact Dr Spada at cristianospada@gmail.com.

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Vol 74 - N° 3

P. 581 - septembre 2011 Retour au numéro

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Second-generation colon capsule endoscopy compared with colonoscopy - 27/08/11

Résumé

Background

Objective

Design and Setting

Patients

Intervention

Main Outcome Measurements

Results

Limitations

Conclusion

Plan

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