Background and study aim: Esophageal capsule endoscopy (ECE) provides an alternative, minimally invasive modality for evaluating the esophagus. This study evaluates the performance and test characteristics of a second-generation esophageal capsule endoscope, the PillCam ESO 2.
Methods: Adults with known or suspected esophageal disease were included. Using the simplified ingestion procedure, each patient underwent capsule endoscopy with the PillCam ESO 2. Following ECE, esophagogastroduodenoscopy (EGD) was performed on the same day by an investigator who was blinded to the results of the ECE. In random order, capsule endoscopy videos were read and interpreted by the study investigator blinded to EGD results.
Results: 28 patients (19 men, 9 women; mean age 53.3 years) were included. In 82 % of the patients, at least 75 % of the Z line was visualized by the PillCam ESO 2. A per-lesion analysis demonstrated that the PillCam ESO 2 had definitive results in 30/43 lesions (69.8 %) and EGD in 29/43 (67.4 %), P value = 0.41. Compared with EGD for detecting suspected Barrett's esophagus and esophagitis, the PillCam ESO 2 had a sensitivity of 100 % and a specificity of 74 %, and a sensitivity of 80 % and a specificity of 87 %, respectively. The PillCam ESO 2 demonstrated 86 % agreement with EGD in describing the Z line (kappa statistic 0.68). The modified ingestion protocol provided excellent cleansing, with bubbles/saliva having no or only a minor effect on Z line images in 86 % of cases.
Conclusions: The PillCam ESO 2 demonstrated excellent visualization of the Z line. Compared with standard EGD, the PillCam ESO 2 had good test characteristics with high rates of detection of suspected Barrett's esophagus and esophagitis. This study provides indirect validation of the simplified ingestion procedure. The PillCam ESO 2 acquires high quality esophageal images, performs safely, and should be able to replace the current PillCam ESO.