Feasibility and Safety of a Novel Cable-Transmitted Magnetically Controlled Capsule Endoscopy System for Upper Gastrointestinal Examination.

BACKGROUND

To evaluate the feasibility and safety of a novel cable-transmitted magnetically controlled capsule endoscopy (CT-MCE) system for upper gastrointestinal examination.

METHODS

Twenty-six participants (19 healthy volunteers and seven patients with gastrointestinal symptoms) willing to undergo upper gastrointestinal endoscopy were recruited. Each participant underwent CT-MCE followed by conventional gastroscopy within 24 h. Maneuverability and visibility of the CT-MCE capsule in the upper gastrointestinal tract, adverse events, and discomfort during the procedure were evaluated. The sensitivity and specificity of CT-MCE for diagnosing upper gastrointestinal lesions were evaluated using conventional gastroscopy findings as the standard.

RESULTS

Maneuverability was graded as "good" for all segments of the esophagus. The percentage of participants in which maneuverability was good according to gastric region was as follows: cardia (100.00%), pylorus (96.15%), angulus (92.31%), antrum (88.46%), fundus (84.62%), and body (73.08%). In the duodenal bulb and descending duodenum, it was good in only 20.83% and 16.67% of participants, respectively. Visibility was graded as "excellent" or "good" in the esophagus, Z line, and duodenal bulb in all participants; excellent/good visibility was achieved in the stomach and descending duodenum in 96.15% and 79.17% of participants, respectively. Forty-one lesions were detected overall. The sensitivity and specificity of CT-MCE in diagnosing upper gastrointestinal lesions were 85.00% and 98.15%, respectively. The CT-MCE capsule was successfully removed through the mouth in all participants. No serious adverse events or capsule retention occurred.

CONCLUSIONS

CT-MCE showed good feasibility and safety for upper gastrointestinal examination. The system was effective in examining the esophagus and stomach with no risk of capsule retention.