Capsule Endoscopy, Small Bowel Disease
Conditions
Keywords
Magnetic steering, MCE, CECR
Brief summary
Patients referred for magnetically controlled capsule endoscopy (MCE) in the participating center from June 2017 to November 2017 were prospectively enrolled. Magnetic steering of MCE was performed after standard gastric examination. Capsule endoscopy completion rate (CECR), gastric transit time (GTT), pyloric transit time (PTT) and rapid gastric transit rate (GTT ≤ 30 min) were compared with the historical control group enrolled from January 2017 to May 2017.
Detailed description
Background and aims: Capsule endoscopy is currently available as a noninvasive and effective diagnostic modality to identify small bowel abnormalities, while the completion rate ranged from 75.1% to 95.6%. A novel magnetically controlled capsule endoscopy (MCE) system could facilitate the capsule to pass through pylorus thereby reducing the gastric transit time (GTT). The investigators perform this study to determine the potential improvement in capsule endoscopy completion rate (CECR) under magnetic steering vs standard mode. Methods: Patients referred for magnetically controlled capsule endoscopy (MCE) in the participating center from June 2017 to November 2017 were prospectively enrolled. Magnetic steering of MCE was performed after standard gastric examination. Capsule endoscopy completion rate (CECR), gastric transit time (GTT), pyloric transit time (PTT) and rapid gastric transit rate (GTT ≤ 30 min) were compared with the historical control group enrolled from January 2017 to May 2017.
Interventions
OTHERmagnetic steering
The capsule was controlled to pass through the pylorus by magnet steering.
Sponsors
Zhuan Liao
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult patients aged over 18 * With gastrointestinal complaints * Scheduled to undergo a capsule endoscopy for both stomach and small bowel
Exclusion criteria
* No surgical condition or refusing abdominal surgery to take out the capsule in case of capsule retention * Implanted pacemaker, except the pacemaker is compatible with MRI * Other implanted electromedical devices or magnetic metal foreign bodies * Pregnancy or suspected pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CECR | Two weeks | Capsule endoscopy completion rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic cases by MCE | Two weeks | Esophageal, gastric, small bowel and colon diseases diagnosed by MCE |
| Transit time | Two weeks | Esophageal/gastric/pyloric/small bowel/total transit time |
| Rapid gastric transit rate | Two weeks | Rate of patients with a gastric transit time of ≤ 30 min |
Countries
China
Outcome results
None listed