Detecting esophageal disease with second-generation capsule endoscopy: initial evaluation of the PillCam ESO 2.

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.

Evaluation of the PillCam Colon capsule in the detection of colonic pathology: results of the first multicenter, prospective, comparative study.

BACKGROUND AND STUDY AIMS: Population-based screening for colorectal cancer is widely recommended, with conventional colonoscopy considered to be the preferred diagnostic modality. However, compliance with screening colonoscopy is low and manpower capacity is limited. Capsule endoscopy might therefore represent a desirable alternative strategy. PATIENTS AND METHODS: The PillCam Colon capsule endoscope was prospectively tested in a multicenter setting. The indications for endoscopy in the enrolled patients included colorectal cancer screening (43 %), postpolypectomy surveillance (26 %), and lower gastrointestinal signs and symptoms (31 %). Study subjects underwent colon preparation and then ingested the capsule on the morning of the examination, with conventional colonoscopy being performed the same day. The PillCam Colon capsule findings were reviewed by three experts in capsule endoscopy who were blinded to the conventional colonoscopy findings. RESULTS: A total of 91 subjects were enrolled in three Israeli centers (55 men, 36 women; mean age 57), and the results were evaluable in 84 cases. The capsule was excreted within 10 hours in 74 % of the patients and reached the rectosigmoid colon in the other 16 %. Of the 84 evaluable patients, 20 (24 %) had significant findings, defined as at least one polyp of 6 mm or more in size or three or more polyps of any size: 14/20 (70 %) were identified with the capsule and 16/20 (80 %) were identified by conventional colonoscopy. Polyps of any size were found in 45 patients, 34/45 (76 %) found by the capsule and 36/45 (80 %) by conventional colonoscopy. In comparison with conventional colonoscopy, false-positive findings on PillCam Colon capsule examination were recorded in 15/45 cases (33 %). There were no adverse events related to the capsule endoscopy. CONCLUSIONS: PillCam Colon capsule endoscopy appears to be a promising new modality for colonic evaluation. Further improvements in the procedure will probably increase capsule examination completion and polyp detection rates. Additional studies are needed to evaluate the accuracy of PillCam Colon endoscopy in other patient populations with different prevalence levels of colonic disease.

PillCam ESO in esophageal studies: improved diagnostic yield of 14 frames per second (fps) compared with 4 fps.

BACKGROUND AND STUDY AIM: Capsule endoscopy, using the PillCam ESO and sending images at a rate of 4 frames per second (fps), has a high sensitivity and specificity in diagnosing gastroesophageal reflux disease (GERD) lesions. We tested a new device which produces images at a rate of 14 fps. The diagnostic performance and esophageal visualization of these two devices were compared. PATIENTS AND METHODS: 42 patients with GERD symptoms and eight patients with a history of Barrett's esophagus had an esophagogastroduodenoscopy (EGD). All patients underwent capsule endoscopy of the esophagus within 1 hour prior to EGD. The first 25 patients had a capsule endoscopy examination with the 4-fps device. The following 25 patients underwent capsule endoscopy under identical conditions but using the 14-fps device. The reader of the capsule endoscopy study was blinded to the EGD findings. A diagnosis of GERD or Barrett's esophagus was established with EGD. The findings at capsule endoscopy were compared with the EGD findings. We also examined how frequently the esophagus in its entirety was visualized by these two devices. RESULTS: The 4-fps device diagnosed 16/19 cases of esophageal erosions or ulcers (sensitivity 84 %) and 6/8 cases of Barrett's esophagus (sensitivity 75 %). The 14-fps capsule diagnosed 16/16 cases of esophageal ulcers or erosions and 7/7 cases of Barrett's esophagus (sensitivity 100 %). The total diagnostic miss rate in the 4-fps group was 5/27 (18 %) whereas the diagnostic miss rate in the 14-fps group was 0/23 (0 %) P < 0.02). The upper esophageal sphincter (UES) was clearly identified in 6/25 patients (24 %) in the 4-fps group and in 20/25 patients (80 %) in the 14-fps group ( P < 0.01). The entire esophagus was well visualized in 3/25 patients (12 %) by the 4-fps device and in 19/25 (76 %) by the 14-fps device ( P < 0.01). The superiority of the 14-fps PillCam ESO capsule is consistent with the data obtained from fluoroscopic studies of swallowed PillCam capsules, showing that capsule speed may reach 20 cm/s. For the 14-fps PillCam this means one image transmitted per 3-cm segment at maximal capsule speed, therefore still allowing for full visualization of the entire esophagus. CONCLUSIONS: Capsule endoscopy using the 14-fps PillCam ESO showed a greater sensitivity than that of the 4-fps device for identifying GERD. The 14-fps PillCam ESO was statistically superior to the 4-fps device in visualizing the opening of the UES and the entirety of the esophagus.