Magnetic Steering Improves Small Bowel Capsule Endoscopy Completion Rate

Not Applicable

Completed

• Conditions: Small Bowel Disease; Capsule Endoscopy
• Interventions: Other: magnetic steering

• Registration Number: NCT03482661
• Lead Sponsor: Zhuan Liao

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.

Study Timeline

• Study Start: 2017-06-01
• Primary Completion: 2017-11-30
• Study Completion: 2017-11-30
• Study First Submitted: 2018-03-05
• Study First Submitted QC: 2018-03-28
• Study First Posted: 2018-03-29
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 227

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnetic steering	magnetic steering	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.

Primary Outcome Measures

Name	Time	Method
CECR	Two weeks	Capsule endoscopy completion rate

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Shanghai Changhai Hospital; 🇨🇳 Shanghai, China