Magnetic Steering Enhance Capsule Gastroscopy Gastric Emptying

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Capsule Endoscopy Gastric Emptying

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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control

The patients swallowed the capsule with water in the lying position.After finishing the stomach examination, the operation of the capsule is adjusted to "small bowel mode" without magnetic control. Capsule entered the duodenum under physiological peristalsis. The position of the capsule was established using a real-time viewer. If the capsule failed to enter the duodenum after one hour, domperidone (10 mg) was orally administered.

Group Type NO_INTERVENTION

No interventions assigned to this group

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".

Group Type EXPERIMENTAL

magnetic steering

Intervention Type OTHER

magnetic steering

Interventions

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magnetic steering

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes