I M Gralnek1, R Rabinovitz, D Afik, R Eliakim. 1. Rappaport Faculty of Medicine, Technion Israel Institute of Technology, Dept. of Gastroenterology, GI Outcomes Unit, Rambam Medical Center, Haifa, Israel.
Abstract
BACKGROUND AND STUDY AIMS: Initial studies on esophageal capsule endoscopy (PillCam ESO) reported excellent sensitivity and specificity, but these were followed by mixed results in several subsequent studies, probably due to deviations from the recommended ingestion protocol and the inconvenience of capsule ingestion in the supine position. The aim of this study was therefore to test a simplified ingestion procedure (SIP) for PillCam ESO. PATIENTS AND METHODS: Using a cross-over study design, the SIP was prospectively compared with the original ingestion procedure for PillCam ESO in 24 healthy volunteers (15 men, nine women; mean age 44, range 27 - 70) and evaluated for: bubbles/saliva interference at the Z-line, Z-line circumferential visualization (quadrants), and convenience and ease of the ingestion procedure. All Rapid 4 videos were reviewed in a randomized manner and read by an experienced PillCam ESO reader blinded to the ingestion procedure used. RESULTS: It was found that the SIP significantly improved visualization in comparison with the original ingestion procedure, with less interference due to bubbles/saliva observed at the gastroesophageal junction ( P = 0.002) and improved visualization of the Z-line ( P = 0.025). Although the esophageal transit time was significantly faster with the SIP (3 : 45 min vs. 0 : 38 min; P = 0.0001), there were no differences in the number of Z-line frames/images captured. CONCLUSIONS: This new, simplified ingestion procedure for PillCam ESO provides significantly improved visualization of the Z-line in healthy volunteers. The overall test characteristics of PillCam ESO using SIP should be tested in patients with esophageal disease.
RCT Entities:
BACKGROUND AND STUDY AIMS: Initial studies on esophageal capsule endoscopy (PillCam ESO) reported excellent sensitivity and specificity, but these were followed by mixed results in several subsequent studies, probably due to deviations from the recommended ingestion protocol and the inconvenience of capsule ingestion in the supine position. The aim of this study was therefore to test a simplified ingestion procedure (SIP) for PillCam ESO. PATIENTS AND METHODS: Using a cross-over study design, the SIP was prospectively compared with the original ingestion procedure for PillCam ESO in 24 healthy volunteers (15 men, nine women; mean age 44, range 27 - 70) and evaluated for: bubbles/saliva interference at the Z-line, Z-line circumferential visualization (quadrants), and convenience and ease of the ingestion procedure. All Rapid 4 videos were reviewed in a randomized manner and read by an experienced PillCam ESO reader blinded to the ingestion procedure used. RESULTS: It was found that the SIP significantly improved visualization in comparison with the original ingestion procedure, with less interference due to bubbles/saliva observed at the gastroesophageal junction ( P = 0.002) and improved visualization of the Z-line ( P = 0.025). Although the esophageal transit time was significantly faster with the SIP (3 : 45 min vs. 0 : 38 min; P = 0.0001), there were no differences in the number of Z-line frames/images captured. CONCLUSIONS: This new, simplified ingestion procedure for PillCam ESO provides significantly improved visualization of the Z-line in healthy volunteers. The overall test characteristics of PillCam ESO using SIP should be tested in patients with esophageal disease.
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