Magnetic Steering Enhance Capsule Gastroscopy Gastric Emptying

Zhuan Liao

Status: Unknown

Conditions: Gastric Emptying; Capsule Endoscopy

Treatments: Other: magnetic steering

Study type: Interventional

Funder types: Other

Identifiers

NCT03441945

MS-enhance-MCCG-GE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

control

No Intervention group

Description:

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.

magnetic steering

Experimental group

Description:

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".

Treatment:

Other: magnetic steering