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

摘要

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.).