Gastric Preparation of Magnetic-controlled Capsule Endoscopy

Phase 2

• Conditions: Stomach Diseases
• Interventions: Other: clear water; Drug: simethicone combined with pronase; Drug: simethicone

• Registration Number: NCT02846155
• Lead Sponsor: Changhai Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2016-05
• Status Verified: 2016-07
• Study First Submitted: 2016-07-21
• Study First Submitted QC: 2016-07-26
• Last Update Submitted: 2016-07-26
• Study First Posted: 2016-07-27
• Last Update Posted: 2016-07-27
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
clear water group	clear water	the patients only drink 1000ml clear water before checking
simethicone combined with pronase group	simethicone combined with pronase	the patients drink 900ml clear water and 15ml simethicone and 20，000iu pronase before checking
simethicone group	simethicone	the patients drink 950ml clear water and 15ml simethicone before checking

Primary Outcome Measures

Name	Time	Method
the level of gastric cleansing	4 month	Two investigators who did not know which kind of gastric preparation of the patient scored the level of gastric cleansing 0f 120 participants according to a four-point grading scale: poor, fair, good, and excellent，which was pointed 3,2,1，and 0.The investigators should evaluate the gastric cleansing of six anatomical landmarks (cardia, fundus, body, angulus, antrum and pylorus).A poor level of cleansing indicated the mucosa was obscured largely by a lot of air bubbles and grume,fair indicated that a portion of the mucosa was obscured by air bubbles and grume that was enough to prevent a reliable visualization of polyps, good indicated that a small amount of air bubbles and grume，and excellent indicated that the fluid was clear and the image was either free or had only small bits of air bubbles and grume.

Secondary Outcome Measures

Name	Time	Method
the time of gastric examination	4 month	the time indicated since the first gastric mucosal image was observed to the endoscopist completed the whole gastric examination。
Transit time	4 month	include gastric transit time，smal bowel transit time
Diagnostic yield of Magnetic-controlled Capsule Endoscopy	4 month	The gastric focal lesion was defined as any of the positive findings including polyp, ulcers, submucosal tumor (SMT) and others (i.e. xanthoma, diverticulum, etc.). Erosion, gastritis and gastric atrophy were defined as negative findings, because they are diffuse lesions which can be easily diagnosed by Magnetic-controlled Capsule Endoscopy.
Tolerability of participants	4 month	The endoscopist scored the tolerability of participants according to a three-point grading scale: poor, fair, and excellent，which was pointed 2,1，and 0.A poor tolerability of participants indicated patients with perforated severe abdominal pain,nausea, vomiting，etc.fair indicated patients with perforated little abdominal pain,nausea, vomiting.and excellent indicated that patients with no obvious discomfort.
the visibility of gastric	4 month	Two investigators scored the level of gastric visibility 0f 120 participants according to a four-point grading scale: poor, fair, good, and excellent，which was pointed 3,2,1,and 0.The investigators should evaluate the visibility of gastric of six anatomical landmarks (cardia, fundus, body, angulus, antrum and pylorus).A poor level of cleansing indicated the less than 50% of mucosa could be seen,fair indicated that 50%-75% of the mucosa could be seen, good indicated that more than 75% of the mucosa could be seen，and excellent indicated the whole mucosa could be seen.
the added amount of water of the whole process during gastric examination	4 month

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, China