A randomized head-to-head study of small-bowel imaging comparing MiroCam and EndoCapsule

Background and study aims: The MiroCam is a new video capsule device offering a higher frame rate and a longer battery life-expectancy. We aimed to quantify its clinical impact and performed a randomized head-to-head comparison with the EndoCapsule device with respect to the rate of complete small-bowel examinations, diagnostic yield in the small bowel, and capsule transit time.

Patients and methods: Patients referred for video capsule endoscopy because of obscure gastrointestinal bleeding, chronic diarrhea, and anemia of unknown origin were randomly assigned to swallow either the MiroCam first, followed by the EndoCapsule 2 hours later, or vice versa. All videos were analyzed by two independent investigators.

Results: A total of 50 patients (median age 61, range 21 – 84) were included. Complete small-bowel examination was achieved in 48 /50 patients using the MiroCam and 45 /50 using the EndoCapsule (96 % vs. 90 %, odds ratio [OR] 2.67, 95 % confidence interval [CI] 0.49 – 14.45; P = 0.38). There was diagnostic yield in the small bowel for 25 /50 patients using the MiroCam and 24 /50 using the EndoCapsule (50 % vs. 48 %, OR 1.08, 95 %CI 0.49 – 2.37; P > 0.99). However, the findings were concordant in 68 % only (kappa = 0.50). The combined diagnostic yield was 58 %. Even solitary findings had a relevant clinical impact during a 6-month follow-up.

Conclusion: In this direct comparison the MiroCam and EndoCapsule devices were not statistically different with regard to their rates of complete small-bowel examinations or diagnostic yield. Their moderate concordance, mainly caused by missed pathological findings, which affected both devices, needs consideration in clinical practice.

• References

• 1 Iddan G, Meron G, Glukhovsky A et al. Wireless capsule endoscopy. Nature 2000; 405: 417
• 2 Delvaux M, Gay G. International conference on capsule and double-balloon endoscopy (ICCD). Paris, 27–28 August 2010. Endoscopy 2011; 43: 533-539
• 3 Carey EJ, Leighton JA, Heigh RI et al. A single-center experience of 260 consecutive patients undergoing capsule endoscopy for obscure gastrointestinal bleeding. Am J Gastroenterol 2007; 102: 89-95
• 4 Doherty GA, Moss AC, Cheifetz AS. Capsule endoscopy for small-bowel evaluation in Crohn's disease. Gastrointest Endosc 2011; 74: 167-175
• 5 Apostolopoulos P, Liatsos C, Gralnek IM et al. The role of wireless capsule endoscopy in investigating unexplained iron deficiency anemia after negative endoscopic evaluation of the upper and lower gastrointestinal tract. Endoscopy 2006; 38: 1127-1132
• 6 Burke CA, Santisi J, Church J et al. The utility of capsule endoscopy small-bowel surveillance in patients with polyposis. Am J Gastroenterol 2005; 100: 1498-1502
• 7 Rondonotti E, Spada C, Cave D et al. Video capsule enteroscopy in the diagnosis of celiac disease: a multicenter study. Am J Gastroenterol 2007; 102: 1624-1631
• 8 de' Angelis GL, Fornaroli F, de' Angelis N et al. Wireless capsule endoscopy for pediatric small-bowel diseases. Am J Gastroenterol 2007; 102: 1749-1757
• 9 Sturniolo GC, Di Leo V, Vettorato MG et al. Small bowel exploration by wireless capsule endoscopy: results from 314 procedures. Am J Med 2006; 119: 341-347
• 10 Westerhof J, Weersma RK, Koornstra JJ. Risk factors for incomplete small-bowel capsule endoscopy. Gastrointest Endosc 2009; 69: 74-80
• 11 Ben-Soussan E, Savoye G, Antonietti M et al. Factors that affect gastric passage of video capsule. Gastrointest Endosc 2005; 62: 785-790
• 12 Triantafyllou K, Kalantzis C, Papadopoulos AA et al. Video-capsule endoscopy gastric and small bowel transit time and completeness of the examination in patients with diabetes mellitus. Dig Liver Dis 2007; 39: 575-580
• 13 Bang S, Park JY, Jeong S et al. First clinical trial of the ‘MiRo’ capsule endoscope by using a novel transmission technology: electric-field propagation. Gastrointest Endosc 2009; 69: 253-259
• 14 Kim HM, Kim YJ, Kim HJ et al. A pilot study of sequential capsule endoscopy using MiroCam and PillCam SB devices with different transmission technologies. Gut Liver 2010; 4: 192-200
• 15 Pioche M, Gaudin JL, Filoche B et al. Prospective, randomized comparison of two small-bowel capsule endoscopy systems in patients with obscure GI bleeding. Gastrointest Endosc 2011; 73: 1181-1188
• 16 Gheorghe C, Iacob R, Bancila I. Olympus capsule endoscopy for small bowel examination. J Gastrointestin Liver Dis 2007; 16: 309-313
• 17 Korman LY, Delvaux M, Gay G et al. Capsule endoscopy structured terminology (CEST): proposal of a standardized and structured terminology for reporting capsule endoscopy procedures. Endoscopy 2005; 37: 951-959
• 18 Bar-Meir S. Review article: capsule endoscopy – are all small intestinal lesions Crohn's disease?. Aliment Pharmacol Ther 2006; 24: 19-21
• 19 Ogata H, Kumai K, Imaeda H et al. Clinical impact of a newly developed capsule endoscope: usefulness of a real-time image viewer for gastric transit abnormality. J Gastroenterol 2008; 43: 186-192
• 20 Caddy G, Moran L, Chong A et al. The effect of erythromycin on video capsule endoscopy intestinal-transit time. Gastrointest Endosc 2006; 63: 262-266
• 21 Niv E, Bogner I, Barkey O et al. Effect of erythromycin on image quality and transit time of capsule endoscopy: A two-center study. World J Gastroenterol 2008; 14: 2561-2565
• 22 Buscaglia JM, Kapoor S, Clarke JO et al. Enhanced diagnostic yield with prolonged small bowel transit time during capsule endoscopy. Int J Med Sci 2008; 5: 303-308
• 23 Carpi F, Pappone C. Magnetic robotic manoeuvring of gastrointestinal video capsules: preliminary phantom tests. Biomed Pharmacother 2008; 62: 546-549
• 24 Swain P, Toor A, Volke F et al. Remote magnetic manipulation of a wireless capsule endoscope in the esophagus and stomach of humans. Gastrointest Endosc 2010; 71: 1290-1293
• 25 Hartmann D, Eickhoff A, Damian U et al. Diagnosis of small-bowel pathology using paired capsule endoscopy with two different devices: a randomized study. Endoscopy 2007; 39: 1041-1045
• 26 Cave DR, Fleischer DE, Leighton JA et al. A multicenter randomized comparison of the Endocapsule and the Pillcam SB. Gastrointest Endosc 2008; 68: 487-494
• 27 Lecleire S, Iwanicki-Caron I, Di-Fiore A. Yield and impact of emergency capsule enteroscopy in severe obscure-overt gastrointestinal bleeding. Endoscopy 2012; 44: 337-342
• 28 Esaki M, Matsumoto T, Yada S et al. Factors associated with the clinical impact of capsule endoscopy in patients with overt obscure gastrointestinal bleeding. Dig Dis Sci 2010; 55: 2294-2301
• 29 Goenka MK, Majumder S, Kumar S et al. Single center experience of capsule endoscopy in patients with obscure gastrointestinal bleeding. World J Gastroenterol 2011; 17: 774-778
• 30 Dolak W, Kulnigg-Dabsch S, Puespoek A. Capsule comparison study Vienna: IntroMedic's MiroCam has a significantly higher diagnostic yield than Olympus' Enteropro EndoCapsule at an interim analysis of 30 patients. Gastrointest Endosc 2011; 73: AB123