INTRODUCTION: Oesophagogastroduodenoscopy is the investigation of choice to identify mucosal lesions of the upper gastrointestinal tract, but it is poorly tolerated by patients. A simple non-invasive technique to image the upper gastrointestinal tract, which could be made widely available, would be beneficial to patients. Capsule endoscopy is well tolerated by patients but the stomach has proved difficult to visualise accurately with capsule technology due to its’ capacious nature and mucosal folds, which can obscure pathology. MiroCam Navi (Intromedic Ltd, Seoul, Korea) is a capsule endoscope containing a small amount of magnetic material which has been made available with a handheld magnet which might allow a degree of control. This body of work aims to address whether this new technology could be a feasible alternative to conventional flexible endoscopy of the stomach.
METHODS: Four studies were conducted to test this research question. The first explores the feasibility of magnetically assisted capsule endoscopy of the stomach and operator learning curve in an ex vivo porcine model. This was followed by a randomised, blinded trial comparing magnetically assisted capsule endoscopy to conventional flexible endoscopy in ex vivo porcine stomach models. Subsequently a prospective, single centre randomised controlled trial in humans examined whether magnetically assisted capsule endoscopy could enhance conventional small bowel capsule endoscopy by reducing gastric transit time. Finally a blinded comparison of diagnostic yield of magnetically assisted capsule endoscopy compared to oesophagogastroduodenoscopy was performed in patients with recurrent or refractory iron deficiency anaemia.
RESULTS: In the first study all stomach tags were identified in 87.2% of examinations and a learning curve was demonstrated (mean examination times for the first 23 and second 23 procedures 10.28 and 6.26 minutes respectively (p<0.001). In the second study the difference in sensitivities between oesophagogastroduodenoscopy and conventional flexible endoscopy for detecting beads within an ex vivo porcine stomach model was 1.11 (95% CI 0.06, 28.26) proving magnetically assisted capsule endoscopy to be non-inferior to flexible endoscopy. In the first human study, although there was no significant difference in gastric transit time or capsule endoscopy completion rate between the two groups (p=0.12 and p=0.39 respectively), the time to first pyloric image was significantly shorter in the intervention group (p=0.03) suggesting that magnetic control hastens capsular transit to the gastric antrum but cannot impact upon duodenal passage. In the last study, a total of 38 pathological findings were identified in this comparative study of magnetically assisted capsule endoscopy and conventional endoscopy. Of these, 16 were detected at both procedures, while flexible endoscopy identified 14 additional lesions not seen at magnetically assisted capsule endoscopy and magnetically assisted capsule endoscopy detected 8 abnormalities not seen by oesophagogastroduodenoscopy. No adverse events occurred in either of the human trials. Finally magnetically steerable capsule endoscopy induced less procedural pain, discomfort and distress than oesophagogastroduodenoscopy (p=0.0009, p=0.001 and p=0.006 respectively).
CONCLUSION: Magnetically assisted capsule endoscopy is safe, well tolerated and a viable alternative to conventional endoscopy. Further research to develop and improve this new procedure is recommended
