Comparative Study of the Magnetically Guided Capsule Endoscopy Versus High Definition Gastroscopy
Condition: Gastric Focal Lesion
Study type: Interventional

Summary: 
      A capsule steered by magnetic field force developed by Siemens and Olympus has recently been
      evaluated in a pilot series in man with encouraging results (Rey JF, Ogata H, Hosoe N,
      Ohtsuka K, Ogata N, Ikeda K, Aihara H, Pangtay I, Hibi T, Kudo S, Tajiri H. Feasibility of
      stomach exploration with a guided capsule endoscope. Endoscopy. 2010;42:541-5. Epub 2010 Jun
      30.18). This blinded prospective study investigates the accuracy of the magnetically guided
      capsule (MGCE) compared to gastroscopy in patients with focal lesions and / or gastric
      symptoms and indication for upper GI Endoscopy.
    

Detailed description: 
      The sudy takes place in a private hospital (Institute Arnault Tzanck, St. Laurent du Var)
      with an annual number of 4000 upper GI endoscopies. Patients will be recruited from this
      center and from the cooperating Department of Gastroenterology at the University of Nice by
      about half. After given written informed consent at least 24 hours prior the examination
      patients are included into the study. The examiners are blinded to the patients origin.

      Participants will be recruited in two groups A) enriched population group (n=50): In both
      institutions, patients presenting for upper GI endoscopy with suspected or diagnosed focal
      lesions as follows; gastric tumors, submucosal tumor, gastric ulcer, polyp a)adenoma,
      b)hyperplastic polyp or angioectasia,ulcers for diagnostic confirmation, follow-up or
      planning of therapy will be informed and asked to participate in the study.

      B) standard gastroscopy group (n=150): consecutive patients without prior gastroscopy
      presenting with the main indications reflux, upper abdominal complaints, anemia and anorexia.
      Here, recruitment is based on presenting symptoms.

      6 endoscopists experienced in upper GI endoscopy (> 1000 examinations) and specifically
      trained in capsule gastroscopy (simulator, 10 gastric capsule cases) will perform capsule
      gastroscopy. 2 well trained endoscopists (> 1000 upper GI endoscopies), different from the
      capsule gastroscopists will perform subsequent gastroscopies. They receive standard
      information about gastroscopy indication from a list of indications. They are accompanied by
      a study nurse who knows patient details but ascertains examiner blindness and takes care of
      secondary unblinding during gastroscopy.

      Gastroscopy is always performed after MGCE in this study with a maximum delay of 1 day but a
      minimum delay of 4 h due to water filling of the stomach with the capsule examination.

      The study is a comparative study of capsule gastroscopy accuracy with conventio¬nal
      gastroscopy serving as gold standard as described above. Disease prevalence is enriched to
      include 25-30% of significant pathology such as tumors and ulcers. Confidence intervals will
      be calculated, e.g. for a disease prevalence of about 30% and 200 study cases, a sensitivity
      of 85% will have a 95% CI of 73-93%. Cross tabulation of the results of the index tests
      (including indeterminate and missing results) will be performed by the results of the
      reference standard. Study statistics will be done by Prof. Dr. Karl Wegscheider, University
      Hospital Hamburg/Eppendorf.

      All patient data will be collected at Institut Arnault Tzanck in St. Laurent du Var. Data
      will be analyzed in pseudonymity way (code, age, sex) at the University of Hamburg. Original
      data will be stored for 10 years at Institut Arnault Tzanck in St. Laurent du Var
    

Intervention name(s): Magnetically Guided Capsule (MGCE)
Intervention type(s): Device
Intervention description(s): "a) MGCE capsule The MGCE capsule is custom-made for observation of the stomach. It is 31 mm in length and 11 mm in diameter and equipped with two image sensors.
It contains a permanent magnet to enable magnetic guidance in the stomach by magnetic field." "b) Guidance system The magnet guidance system is custom-made to guide the MGCE capsule inside the stomach. It has a footprint of 1m× 2m and generates a very low level magnetic fields." c) Conventional gastroscope
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: Magnetically guided capsule endoscopy (MGCE); Gastroscopy