Magnetic Steering Enhance Capsule Gastroscopy Gastric Emptying

Not Applicable

• Conditions: Capsule Endoscopy; Gastric Emptying
• Interventions: Other: magnetic steering

• Registration Number: NCT03441945
• Lead Sponsor: Zhuan Liao

Brief Summary

The research continuously enrolled 100 patients undergone MCCG between May to December 2017 as the intervention group with magnetic steering of capsule in the pylorus and duodenum, and randomly selected 100 patients before May 2017 from the database as the control group with passive movement of the capsule. The difference of the pyloric transit time (PTT) and duodenal papilla detection rate (DPDR) between the two groups were compared, and related factors were also investigated.

Detailed Description

Background and Aims: Capsule endoscopy is a valuable tool in the diagnosis of small bowel disease. However, the incompletion of small bowel examination may reduce the diagnostic accuracy, which mainly caused by delayed capsule gastric emptying. Thus the aim of this study was to validate the effect of magnetic steering on enhancing gastric emptying and mucosal visualization within duodenum during magnetically controlled capsule gastroscopy (MCCG) examination.

Methods: As a historical prospective cohort study, the research continuously enrolled 100 patients undergone MCCG between May to December 2017 as the intervention group with magnetic steering of capsule in the pylorus and duodenum, and randomly selected 100 patients before May 2017 from the database as the control group with passive movement of the capsule. The difference of the pyloric transit time (PTT) and duodenal papilla detection rate (DPDR) between the two groups were compared, and related factors were also investigated.

Study Timeline

• Study Start: 2017-05-01
• Status Verified: 2018-02
• Study First Submitted: 2018-02-08
• Study First Submitted QC: 2018-02-15
• Last Update Submitted: 2018-02-15
• Study First Posted: 2018-02-22
• Last Update Posted: 2018-02-22
• Primary Completion: 2018-02-28
• Study Completion: 2018-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. patients over 18 years of age undergone MCCG examination in Changhai Hospital

Exclusion Criteria

1. pregnancy or suspected pregnancy;
2. suspected or known intestinal stenosis;
3. pacemaker, other implanted electro medical devices which could interfere with magnetic resonance; (4) undergone a known surgery which could possibly affect visualization of the duodenal papilla;

(5) other conditions which may lead to capsule retention.

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. After reaching the duodenal bulb, capsule was held to the maximum position of "Z", then the capsule would scan the duodenal bulb automatically with the mode "360° automatic scanning".

Primary Outcome Measures

Name	Time	Method
PTT	3 month	pyloric transit time

Secondary Outcome Measures

Name	Time	Method
DPDR	3 month	duodenal papilla detection rate

Trial Locations

Locations (1)

Shanghai Changhai Hospital; 🇨🇳 Shanghai, China