Magnetically steerable gastric capsule endoscopy is equivalent to flexible endoscopy in the detection of markers in an excised porcine stomach model: results of a randomized trial

Background and study aims: Capsule endoscopy is well tolerated but control of its movement is needed in order to visualize the whole gastric surface. Technological developments have produced an external magnet to allow manipulation of the capsule within the gastric cavity. The aim of this study was to compare magnetically steerable gastric capsule endoscopy (MSGCE) with flexible endoscopy for the detection of beads in a porcine stomach.

Materials and methods: Beads were sewn onto the mucosal surface of 12 ex vivo porcine stomachs. Each model was examined by flexible endoscopy and MSGCE by two blinded investigators. MSGCE was performed according to a protocol using positional changes and magnetic steering. Outcome measures were number and location of beads identified, and duration of procedure.

Results: Flexible endoscopy identified 79 /90 beads (88 %), and MSGCE identified 80 /90 (89 %). The difference in sensitivities was 1.11 (95 % confidence interval 0.06 – 28.26). Thus, MSGCE was noninferior to flexible endoscopy. Mean examination times for flexible endoscopy and MSGCE were 3.34 minutes and 9.90 minutes, respectively.

Conclusion: MSGCE was equivalent to conventional flexible endoscopy in the detection of beads in a porcine stomach model.

• References

• 1 Brandt LJ. Patients’ attitudes and apprehensions about endoscopy: how to calm troubled waters. Am J Gastroenterol 2001; 96: 280-284
• 2 Campo R, Brullet E, Montserrat A et al. Identification of factors that influence tolerance of upper gastrointestinal endoscopy. Eur J Gastroenterol Hepatol 1999; 11: 201-204
• 3 Bell GD. Preparation, premedication, and surveillance. Endoscopy 2004; 36: 23-31
• 4 Bersani G, Rossi A, Suzzi A et al. Comparison between the two systems to evaluate the appropriateness of endoscopy of the upper digestive tract. Am J Gastroenterol 2004; 99: 2128-2135
• 5 Keller J, Fibbe C, Volke F et al. Inspection of the human stomach using remote-controlled capsule endoscopy: a feasibility study in healthy volunteers (with videos). Gastrointest Endosc 2011; 73: 22-28
• 6 Liao Z, Duan XD, Xin L et al. Feasibility and safety of magnetic-controlled capsule endoscopy system in examination of human stomach: a pilot study in healthy volunteers. J Interv Gastroenterol 2012; 2: 155-160
• 7 Hale M, Drew K, Baldacchino T et al. Gastroscopy without a gastroscope! Feasibility in a porcine stomach model using a magnetic capsule.. Gut 2013; 62: A156
• 8 Miettinen O, Nurminen M. Comparative analysis of two rates. Stat Med 1985; 4: 213-226
• 9 Neale JR, James S, Callaghan J et al. Premedication with N-acetylcysteine and simethicone improves mucosal visualization during gastroscopy: a randomized, controlled, endoscopist-blinded study. Eur J Gastroenterol Hepatol 2013; 25: 778-783
• 10 Lee GJ, Park SJ, Kim SJ et al. Effectiveness of premedication with pronase for visualization of the mucosa during endoscopy: a randomized, controlled trial. Clin Endosc 2012; 45: 161-164
• 11 Rey JF, Ogata H, Hosoe N et al. Blinded nonrandomized comparative study of gastric examination with a magnetically guided capsule endoscope and standard videoendoscope. Gastrointest Endosc 2012; 75: 373-381
• 12 Ciuti G, Donlin R, Valdastri P et al. Robotic versus manual control in magnetic steering of an endoscopic capsule. Endoscopy 2010; 42: 148-152
• 13 Hiki N, Kurosaka H, Tatsutomi Y et al. Peppermint oil reduces gastric spasm during upper endoscopy: a randomized, double-blind, double-dummy controlled trial. Gastrointest Endosc 2003; 57: 475-482
• 14 Heresbach D, Barrioz T, Lapalus MG et al. Miss rate for colorectal neoplastic polyps: a prospective multicenter study of back-to-back video colonoscopies. Endoscopy 2008; 40: 284-290
• 15 Tee HP, Kaffes AJ. Non-small-bowel lesions encountered during double-balloon enteroscopy performed for obscure gastrointestinal bleeding. World J Gastroenterol: WJG 2010; 16: 1885-1889