Gastric Preparation of Magnetic-controlled Capsule Endoscopy

Stomach Diseases Clinical Trial

Official title:

Gastric Preparation of Magnetic-controlled Capsule Endoscopy: A Prospective, Single Blinded and Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02846155
• Other study ID #: 20160410A
• Status: Recruiting
• Phase: Phase 2
• First received: July 21, 2016
• Last updated: July 26, 2016
• Start date: May 2016
• Est. completion date: December 2016

Study information

• Verified date: July 2016
• Source: Changhai Hospital
• Contact: Zhuan Liao
• Email: liaozhuan[@]smmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Stomach Diseases

Intervention

Other:
• clear water
the patients just drink common clear water before Magnetic-controlled Capsule Endoscopy examination

Drug:
• simethicone
the patients drink clear water and simethicone (Espumisan; Berlin-Chemie, Germany, containing 40 mg simethicone in 1 mL emulsion) before Magnetic-controlled Capsule Endoscopy examination
• simethicone combined with pronase
the patients drink simethicone (Espumisan; Berlin-Chemie, Germany, containing 40 mg simethicone in 1 mL emulsion),pronase granules(Deyou;Beijing Tide Pharmaceutical Co,China,containing 20,000iu pronase),and clear water before Magnetic-controlled Capsule Endoscopy examination

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai
China	Changhai Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the level of gastric cleansing	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.	4 month	Yes
Secondary	Transit time	include gastric transit time,smal bowel transit time	4 month	Yes
Secondary	Diagnostic yield of Magnetic-controlled Capsule Endoscopy	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.	4 month	Yes
Secondary	Tolerability of participants	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.	4 month	Yes
Secondary	the visibility of gastric	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.	4 month	Yes
Secondary	the time of gastric examination	the time indicated since the first gastric mucosal image was observed to the endoscopist completed the whole gastric examination?	4 month	Yes
Secondary	the added amount of water of the whole process during gastric examination		4 month	Yes