Prospective, randomized comparison of two small-bowel capsule endoscopy systems in patients with obscure GI bleeding

Abstract

Background: Video capsule endoscopy is the first-intention examination in patients with obscure GI bleeding. The new MiroCam capsule, when using electric-field propagation for transmission, has been poorly evaluated in a clinical setting, in contrast with the PillCam SB2 capsule.

Objective: To evaluate the diagnostic concordance (κ value) between PillCam SB2 and MiroCam capsule examinations performed in the same patients.

Design and setting: Prospective, randomized study in 7 endoscopy units.

Patients and intervention: Eighty-three consecutive patients, ingesting the 2 capsules at a 1-hour interval.

Results: Seventy-three patients were analyzed (10 technical issues). There were 31 concordant negative cases (42.4%) and 30 concordant positive cases (41.1%). The study showed satisfactory diagnostic concordance between the 2 systems (κ = 0.66). In 12 patients (16.4%), the final diagnosis was different: 9 patients had positive findings on MiroCam examination but no image detected with PillCam SB2, 2 had positive findings on PillCam examination only, and 1 patient had 2 different diagnoses. A positive diagnosis was obtained in 46.6% and 56.2% of patients with PillCam SB2 and MiroCam capsule, respectively, so that the procedures identified 78.6% and 95.2% of positive cases, respectively (P = .02). Small-bowel transit time and capsule reading time were significantly longer in MiroCam procedures.

Limitations: Technical failures possibly related to capsule interference.

Conclusion: This study shows at least comparable efficiency of the MiroCam compared with the PillCam SB2 capsule system for the diagnosis of obscure GI bleeding.