Magnetic Steering Improves Small Bowel Capsule Endoscopy Completion Rate

Study Overview
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Brief Summary
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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
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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.

Official Title
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Magnetic Steering of Capsule Endoscopy Improves Small Bowel Capsule Endoscopy Completion Rate

Conditions
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Capsule Endoscopy, Small Bowel Disease

Intervention / Treatment
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* Other: magnetic steering


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>The patients swallowed the capsule with water in the supine position. When the capsule reached the stomach, the capsule was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After completing the stomach examination, the capsule moved automatically without magnetic control and entered the duodenum under physiological conditions. The position of the capsule was verified through real-time viewer. | |
| Experimental: Magnetic steering<br>After finishing the stomach examination as the control protocol, the capsule was lifted with the magnetic control, then rotating the capsule until the camera end oriented toward the pylorus . Next, the endoscopist could drag the capsule close to the pylorus with the guidance magnet robot, waiting for the open of pylorus. Once the pylorus opened, the capsule could enter the duodenum with gastric peristalsis. | Other: magnetic steering<br>* The capsule was controlled to pass through the pylorus by magnet steering.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CECR | Capsule endoscopy completion rate | Two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic cases by MCE | Esophageal, gastric, small bowel and colon diseases diagnosed by MCE | Two weeks | 
| Transit time | Esophageal/gastric/pyloric/small bowel/total transit time | Two weeks | 
| Rapid gastric transit rate | Rate of patients with a gastric transit time of ≤ 30 min | Two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MCE, Magnetic steering, CECR