Sabina Beg1, Tim Card2, Samantha Warburton1, Imdadur Rahman3, Emilie Wilkes1, Jonathan White1, Krish Ragunath1. 1. NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham; Nottingham Digestive Diseases Centre, University of Nottingham, Nottingham. 2. NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham; Nottingham Digestive Diseases Centre, University of Nottingham, Nottingham; Division of Epidemiology and Public Health, School of Medicine, University of Nottingham, Nottingham. 3. University Hospital Southampton NHS trust, Southampton, United Kingdom.
Abstract
BACKGROUND AND AIMS: Magnetically assisted capsule endoscopy (MACE) potentially offers a comfortable, patient friendly, and community-based alternative to gastroscopy (EGD). This pilot study aims to explore whether this approach can be used to accurately diagnose Barrett's esophagus (BE) and esophageal varices. METHOD: The MiroCam Navi capsule system was used to examine the upper GI tract in patients due to undergo a clinically indicated EGD. A total of 50 participants were enrolled: 34 had known pathology (17 BE, 17 esophageal varices [EV]) and 16 controls. Patients underwent the MACE procedure with the operator blinded to the indication and any previous endoscopic diagnoses. The subsequent EGD was performed by an endoscopist blinded to the MACE findings. Diagnostic yield, comfort, and patient preference between the 2 modalities were compared. RESULTS: The mean age of the participants was 61 years, the male/female ratio was 2.1:1, the mean body mass index was 29.5 kg/m2, and the average chest measurement was 105.3 cm. Forty-seven patients underwent both procedures; 3 patients were unable to swallow the capsule. With the use of the magnet, it was possible to hold the capsule within the esophagus for a mean duration of 190 seconds and up to a maximum of 634 seconds. A correct real-time MACE diagnosis was made in 11 of 15 patients with EV (sensitivity 73.3% [95% confidence interval (CI), 44.9%-92.2%] and specificity 100% [95% CI, 89.1%-100%]) and 15 of 16 patients with BE (sensitivity 93.8% [95% CI, 69.8%-99.8%] and specificity of 100% [95% CI, 88.8%-100%]). MACE was considered more comfortable than conventional endoscopy (P < .0001); the mean score was 9.2 for MACE compared with 6.7 for EGD when assessed on a 10-point scale. No MACE- or EGD-related adverse events occurred. CONCLUSION: This pilot study demonstrates that MACE is both safe and well tolerated by patients. Accuracy for the diagnosis of BE was high, and therefore MACE may have a role in screening for this condition. (Clinical trial registration number: NCT02852161.). Crown
BACKGROUND AND AIMS: Magnetically assisted capsule endoscopy (MACE) potentially offers a comfortable, patient friendly, and community-based alternative to gastroscopy (EGD). This pilot study aims to explore whether this approach can be used to accurately diagnose Barrett's esophagus (BE) and esophageal varices. METHOD: The MiroCam Navi capsule system was used to examine the upper GI tract in patients due to undergo a clinically indicated EGD. A total of 50 participants were enrolled: 34 had known pathology (17 BE, 17 esophageal varices [EV]) and 16 controls. Patients underwent the MACE procedure with the operator blinded to the indication and any previous endoscopic diagnoses. The subsequent EGD was performed by an endoscopist blinded to the MACE findings. Diagnostic yield, comfort, and patient preference between the 2 modalities were compared. RESULTS: The mean age of the participants was 61 years, the male/female ratio was 2.1:1, the mean body mass index was 29.5 kg/m2, and the average chest measurement was 105.3 cm. Forty-seven patients underwent both procedures; 3 patients were unable to swallow the capsule. With the use of the magnet, it was possible to hold the capsule within the esophagus for a mean duration of 190 seconds and up to a maximum of 634 seconds. A correct real-time MACE diagnosis was made in 11 of 15 patients with EV (sensitivity 73.3% [95% confidence interval (CI), 44.9%-92.2%] and specificity 100% [95% CI, 89.1%-100%]) and 15 of 16 patients with BE (sensitivity 93.8% [95% CI, 69.8%-99.8%] and specificity of 100% [95% CI, 88.8%-100%]). MACE was considered more comfortable than conventional endoscopy (P < .0001); the mean score was 9.2 for MACE compared with 6.7 for EGD when assessed on a 10-point scale. No MACE- or EGD-related adverse events occurred. CONCLUSION: This pilot study demonstrates that MACE is both safe and well tolerated by patients. Accuracy for the diagnosis of BE was high, and therefore MACE may have a role in screening for this condition. (Clinical trial registration number: NCT02852161.). Crown