A comparative study of MACE and gastroscopy in upper GI bleeding
Research type
Research Study
Full title
An observer blinded comparison of magnetically assisted capsule endoscopy and conventional upper gastrointestinal endoscopy in upper gastrointestinal bleeding
IRAS ID
198322
Contact name
Mark McAlindon
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
Gastroscopy (OGD) is a useful test for investigating a variety of suspected upper GI disorders. But it is uncomfortable for patients and incurs the risk of intubation and sedation, plus a large proportion of procedures reveal insignificant or no pathology. \nCapsule endoscopy (CE) is the investigation of choice for diseases of the small bowel. It is safe, non-invasive and well-tolerated. The use of CE is traditionally restricted to the small bowel, although newer capsules to image the oesophagus and colon are currently in use. Previous capsules have failed to adequately image the stomach due to its’ large volume and rugal folds. Recently a magnetic capsule and handheld magnet has been developed (Mirocam Navi, Intromedic Ltd, Seoul, Korea) to enable an element of manoeuvrability of the capsule. This is unnecessary in the small bowel where the capsule is propelled along its’ tubular structure by peristalsis, but in the capacious stomach this may allow the capsule to be steered to examine all areas of the stomach.\nWe have already conducted two feasibility studies in porcine models with promising results and a trial has already evaluated the equipment to steer the small bowel capsule through the stomach into the duodenum. An ongoing study is comparing the ability of this technique to examine the stomach against conventional OGD, in patients with recurrent iron deficiency anaemia. The next stop would be to compare the two modalities under other different conditions. \nWe wish to undertake a prospective single blind controlled trial comparing magnetically assisted capsule examination to conventional OGD in diagnosing upper gastrointestinal pathology in patients with gastrointestinal bleeding.\n
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
16/YH/0039
Date of REC Opinion
26 Apr 2016
REC opinion
Further Information Favourable Opinion