Gastric Preparation of Magnetic-controlled Capsule Endoscopy

Naval Military Medical University

Status and phase: Unknown; Phase 2

Conditions: Stomach Diseases

Treatments: Drug: simethicone combined with pronase; Drug: simethicone; Other: clear water

Study type: Interventional

Funder types: Other

Identifiers

NCT02846155

20160410A

Details and patient eligibility

About

By using three different Gastric Preparation of Magnetic-controlled Capsule Endoscopy, the investigators hope to find out the optimal gastric preparation plan.

Full description

It is a prospective, single-blind, randomized controlled trial. Patients who were conducted by Magnetic-controlled Capsule Endoscopy at Changhai Hospital will be randomly allocated into three different Gastric Preparation group before the procedure. It include clear water group which patient only drink 1000ml clear water before checking; simethicone group which patient drink 950ml clear water and 15ml simethicone before checking; simethicone combined with pronase group which patient drink 900ml lear water and 15ml simethicone and 20，000iu pronase before checking. The result were got from a relevant professional physician's blinded independent image-reading.

Enrollment: 120 estimated patients

Sex: All

Ages: 16 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult patients aged 16-75 years, who were scheduled to undergo a Magnetic-controlled Capsule Endoscopy, were eligible for this study.

Exclusion criteria

• Dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, overt gastrointestinal bleeding, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy, or postabdominal radiation;
• Congestive heart failure, renal insufficiency, under therapeutic anticoagulation, in poor general condition (American Society of Anesthesiologists class III/IV), claustrophobia, metallic parts, a pacemaker or other implanted electromedical devices, artificial heart valves;
• Pregnancy or suspected pregnancy;
• Exclusion criteria for standard magnetic resonance imaging (MRI) examination such as the presence of surgical metallic devices, even though its low magnetic field would technically not interfere with such devices;
• Currently participating in another clinical study.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups, including a placebo group

clear water group

Placebo Comparator group

Description:

the patients only drink 1000ml clear water before checking

Treatment:

Other: clear water

simethicone group

Experimental group

Description:

the patients drink 950ml clear water and 15ml simethicone before checking

Treatment:

Drug: simethicone

simethicone combined with pronase group

Experimental group

Description:

the patients drink 900ml clear water and 15ml simethicone and 20，000iu pronase before checking

Treatment:

Drug: simethicone combined with pronase