Back to resultsGastric Preparation of Magnetic-controlled Capsule Endoscopy
Primary Purpose
Stomach Diseases
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
clear water
simethicone
simethicone combined with pronase
Sponsored by
About this trial
This is an interventional diagnostic trial for Stomach Diseases focused on measuring preparation, capsule endoscopy
Eligibility Criteria
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.
Sites / Locations
- Changhai HospitalRecruiting
- Changhai HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
clear water group
simethicone group
simethicone combined with pronase group
Arm Description
the patients only drink 1000ml clear water before checking
the patients drink 950ml clear water and 15ml simethicone before checking
the patients drink 900ml clear water and 15ml simethicone and 20，000iu pronase before checking
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Transit time
include gastric transit time，smal bowel transit time
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.
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.
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.
the time of gastric examination
the time indicated since the first gastric mucosal image was observed to the endoscopist completed the whole gastric examination。
the added amount of water of the whole process during gastric examination
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02846155
Brief Title
Gastric Preparation of Magnetic-controlled Capsule Endoscopy
Official Title
Gastric Preparation of Magnetic-controlled Capsule Endoscopy: A Prospective, Single Blinded and Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Diseases
Keywords
preparation, capsule endoscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
clear water group
Arm Type
Placebo Comparator
Arm Description
the patients only drink 1000ml clear water before checking
Arm Title
simethicone group
Arm Type
Experimental
Arm Description
the patients drink 950ml clear water and 15ml simethicone before checking
Arm Title
simethicone combined with pronase group
Arm Type
Experimental
Arm Description
the patients drink 900ml clear water and 15ml simethicone and 20，000iu pronase before checking
Intervention Type
Other
Intervention Name(s)
clear water
Intervention Description
the patients just drink common clear water before Magnetic-controlled Capsule Endoscopy examination
Intervention Type
Drug
Intervention Name(s)
simethicone
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
simethicone combined with pronase
Intervention Description
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
Primary Outcome Measure Information:
Title
the level of gastric cleansing
Description
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.
Time Frame
4 month
Secondary Outcome Measure Information:
Title
Transit time
Description
include gastric transit time，smal bowel transit time
Time Frame
4 month
Title
Diagnostic yield of Magnetic-controlled Capsule Endoscopy
Description
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.
Time Frame
4 month
Title
Tolerability of participants
Description
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.
Time Frame
4 month
Title
the visibility of gastric
Description
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.
Time Frame
4 month
Title
the time of gastric examination
Description
the time indicated since the first gastric mucosal image was observed to the endoscopist completed the whole gastric examination。
Time Frame
4 month
Title
the added amount of water of the whole process during gastric examination
Time Frame
4 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhuan Liao
Email
liaozhuan@smmu.edu.cn
Facility Information:
Facility Name
Changhai Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhuan Liao
Email
liaozhuan@smmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Shu Guang Zhu
Facility Name
Changhai Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhuan Liao
Email
liaozhuan@smmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Shu-Guang Zhu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Gastric Preparation of Magnetic-controlled Capsule Endoscopy
We'll reach out to this number within 24 hrs