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Small-sized versus standard magnetic capsule endoscopy in adults: a two-center, double-blinded randomized controlled trialSupported by: Shandong Provincial Key Research and Development Program (Major Scientific and Technological Innovation Project ) 2019JZZY011007
Supported by: Shanghai Municipal Hospital Emerging Frontier Technology Joint Project SHDC12019105
Supported by: “Ten Thousand Plan”-National High Level Talents Special Support Plan
Trial Registration: ClinicalTrials.gov Registration number (trial ID): NCT05073536 Type of study: Prospective, Randomized, Two-Center Study
Background Certain patients experience difficulty swallowing a video capsule endoscopy (VCE) device owing to its relatively large size. The newly developed small-sized magnetically controlled capsule endoscopy (MCE) device is the smallest VCE device ever reported. We aimed to evaluate the performance of the small-sized MCE device in terms of ingestion and examination efficacy.
Methods Patients in two centers were prospectively enrolled and randomized to the small-sized or standard MCE groups. Differences in capsule ingestion difficulties, visualization of the gastrointestinal tract, and capsule transit times were compared.
Results 96 patients were enrolled (48 in each group). In the small-sized MCE group, the mean (SD) difficulty score and time to swallow the capsule, and success rate for swallowing the capsule at the first attempt were 0.6 (1.0), 3.4 (1.3) seconds, and 89.6 %, which was significant better compared with the standard MCE group with 3.1 (1.7), 12.0 (14.3) seconds and 60.4 %, respectively (all P < 0.001). Visualization of the esophagus, stomach, and small bowel were comparable between the two groups. The small-sized MCE group had a significantly shorter gastric transit time (49.4 minutes vs. 66.2 minutes; P = 0.04) and longer small-bowel transit time (5.8 hours vs. 5.0 hours; P = 0.045).
Conclusions The small-sized MCE device is feasible and safe for gastrointestinal examination, alleviating difficulties in capsule ingestion, improving gastric emptying under magnetic control, and prolonging the small-bowel transit time.
* Joint first authors
Received: 20 December 2021
Accepted after revision: 20 May 2022
Article published online:
12 July 2022
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