A multicenter, prospective, randomized comparison of a novel signal transmission capsule endoscope to an existing capsule endoscope

Background MiroCam, a capsule endoscope, uses a novel transmission technology, electric-field propagation, which uses the human body as a conduction medium for data transmission. Objective To compare the ability of the MiroCam (MC) and PillCam (PC) to identify sources of obscure GI bleeding (OGIB)....

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Veröffentlicht in:	Gastrointestinal endoscopy 2013-08, Vol.78 (2), p.325-332
Hauptverfasser:	Choi, Eric H., MD, Mergener, Klaus, MD, PhD, MBA, Semrad, Carol, MD, Fisher, Laurel, MD, Cave, David R., MD, Dodig, Milan, MD, Burke, Carol, MD, Leighton, Jonathan A., MD, Kastenberg, David, MD, Simpson, Peter, MD, Sul, James, MD, Bhattacharya, Kanishka, MD, Charles, Roger, MD, Gerson, Lauren, MD, MSc, Weber, Luke, MD, Eisen, Glenn, MD, Reidel, Warren, MD, Vargo, John J., MD, Wakim-Fleming, Jamile, MD, Lo, Simon K., MD
Format:	Artikel
Sprache:	eng
Schlagworte:	Adult Aged Aged, 80 and over Capsule Endoscopes Capsule Endoscopy - methods Equipment Design Female Gastroenterology and Hepatology Gastrointestinal Hemorrhage - diagnosis Humans Intestine, Small - pathology Male Middle Aged Operative Time Young Adult
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Zusammenfassung:	Background MiroCam, a capsule endoscope, uses a novel transmission technology, electric-field propagation, which uses the human body as a conduction medium for data transmission. Objective To compare the ability of the MiroCam (MC) and PillCam (PC) to identify sources of obscure GI bleeding (OGIB). Design Prospective, multicenter, comparative study. Setting Six academic hospitals. Patients A total of 105 patients with OGIB. Intervention Patients ingested both the MC and PC capsules sequentially in a randomized fashion. Main Outcome Measurements Concordance of rates in identifying a source of OGIB, operational times, and rates of complete small-bowel examination. Results Data analysis resulted in 43 (48%) “abnormal” cases identifying a source of OGIB by either capsule. Twenty-four cases (55.8%) were positive by both capsules. There was negative agreement in 46 of 58 cases (79.3%). The κ index was 0.547 (χ2 = 1.32; P = .36). In 12 cases, MC positively identified a source that was not seen on PC, whereas in 7 cases, PC positively identified a source that was not seen on MC. MC had a 5.6% higher rate of detecting small-bowel lesions ( P = .54). MC captured images at 3 frames per second for 11.1 hours, and PC captured images at 2 frames per second for 7.8 hours ( P < .0001). Complete small-bowel examination was achieved in 93.3% for MC and 84.3% for PC ( P = .10). Limitations Readers were not blinded to the particular capsule they were reading. Conclusion A positive diagnostic finding for OGIB was identified by either capsule in 48% of cases. The concordance rate between the 2 capsules was comparable to that of prior studies in identifying sources of small-bowel bleeding. The longer operational time of the MC may result in higher rates of complete small-bowel examination, which may, in turn, translate into a higher rate of detecting small-bowel lesions. (Clinical trial registration number: NCT00878982 .)
ISSN:	0016-5107 1097-6779
DOI:	10.1016/j.gie.2013.02.039