Magnetic-controlled capsule endoscopy vs. gastroscopy for gastric diseases: a two-center self-controlled comparative trial.

BACKGROUND AND STUDY AIMS: We developed a novel magnetic-controlled capsule endoscopy (MCE) system for use in the human stomach. The aim of the current study was to compare the diagnostic accuracy of MCE with that of standard gastroscopy for gastric diseases. PATIENTS AND METHODS: A total of 68 patients were enrolled in this self-controlled trial. Patients were evaluated by both MCE and gastroscopy. Gastroscopy was performed 4 – 24 hours after completion of the MCE examination.
RESULTS: The positive percent agreement between MCE and gastroscopy was 96.0 %, and the negative percent agreement was 77.8 %. The overall agreement was 91.2 % with a kappa value of 0.765 (P < 0.001). A total of 68 pathological findings were detected, of which 53 were identified by both methods. The MCE and standard gastroscopy missed seven and eight findings, respectively.
CONCLUSIONS: MCE showed a diagnostic accuracy similar to that of standard gastroscopy. These results suggest that MCE is a promising alternative to gastroscopy for noninvasive screening of gastric diseases.Clinical trial registration number: NCT01903629.

RCT Entities:   Population Interventions Outcomes