Back to resultsMini-sized MCE for Detection of Small Bowel in Children Under the Age of 10 Years
Primary Purpose
Small Bowel Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Mini-sized MCE
Normal-sized MCE
Sponsored by
About this trial
This is an interventional other trial for Small Bowel Disease focused on measuring Children, Small Bowel Disease, Capsule Endoscopy
Eligibility Criteria
Inclusion Criteria:
- Patients and their legal guardians agreed to participate in the study and signed informed consent;
- 2 years ≤ age < 10 years;
- Pediatric patients with suspected small bowel disease who are scheduled for small bowel capsule endoscopy
Exclusion Criteria:
- Intestinal obstruction, stenosis, or fistula is known or suspected;
- Dysphagia or gastric emptying dysfunction;
- Severe asthma, dysphagia or gastroparesis and other emptying disorders;
- Known or suspected possibility of major bleeding from active digestive tract;
- The presence of a pacemaker in the body, except where the pacemaker is a new MRI-compatible product;
- Implanted cochlear implants, magnetic metal drug infusion pumps, nerve stimulators and other electronic devices, as well as magnetic metal foreign bodies;
- Those who plan to undergo magnetic resonance imaging (MRI) examination before capsule endoscopy discharge;
- Previous history of abdominal surgery affecting the normal structure of the digestive tract;
- Patients with mental illness;
- Allergic to macromolecular materials such as dimethyl silicone oil;
- Refuse to use electronic gastroscopy to deliver the capsule to the duodenum if the capsule cannot be swallowed by itself;
- Contraindications of intravenous anesthesia;
- Patients who have participated in or are participating in other clinical trials within three months;
- Any other factors considered by the investigator to be inappropriate for enrollment or to affect the participant's participation in the study.
Sites / Locations
- Qilu Children's Hospital
- Shanghai Changhai Hospital
- Shanghai Children's Hospital
- Xi'an Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Mini-sized MCE
Normal sized CE
Arm Description
AKES-31SW Capsule Endoscopy
PillCam Capsule Endoscopy
Outcomes
Primary Outcome Measures
Success rate of self-swallowing with Mini-sized MCE
Self-swallowing was defined as the subjects swallowing capsules for examination by themselves, and no endoscope or other instruments were needed to place capsules during the entire examination process
Secondary Outcome Measures
Completion rate of capsule endoscopy gastric examination in two groups
The stomach was divided into six parts: cardia, fundus, body, antrum, angle and pylorus. The proportion of all subjects who completed complete observation of the six anatomical parts.
Completion rate of small bowel examination by capsule endoscopy in two groups
Small bowel examination completion definition: All subjects reached the cecum with capsule endoscopy and completed small bowel examination.
Success rate of instrument-assisted examination in the two groups
The success rate of device-assisted examination was defined as the proportion of small bowel examinations performed by endoscopists using endoscope-assisted capsules.
Two groups of capsule endoscopy swallowing time
Swallowing time was defined as the time between the time when the patient first placed the capsule in the mouth and the time when the patient took the first image of the esophagus.
Two groups of capsule endoscopy swallowing intake of water
Definition of water intake in swallowing capsule: The total amount of water ingested by the subject after swallowing the capsule successfully or unsuccessfully using a measuring cup.
The degree of difficulty of capsule swallowing in the two groups
Swallowing difficulty is assessed on a scale of 0-5, with 0 being no difficulty and 5 being the most difficult.
Factors affecting swallowing by capsule endoscopy
Physiological parameter such as BMI were recorded
Factors affecting gastrointestinal retention under capsule endoscopy
The incidence of capsule retention due to anesthesia or intestinal obstruction was recorded
The transmit time of esophagus, the transmit time of stomach, the transmit time of small intestine and the retention time of capsule in two groups
The time of the first esophageal image, the first stomach image, the first small intestine image, the first large intestine image and the last image taken by capsule endoscopy were recorded.
Esophageal transmit time: time of first stomach image minus time of first esophageal image Stomach transmit time: time of first small intestine image minus time of first stomach image Small bowel transmit time: the time of the first large intestine image minus the time of the first small intestine image Total retention time of the capsule in vivo: total recording time of the capsule in vivo, which is the time of the last image of the capsule minus the time of the first image of the esophagus.
The time of gastric examination was magnetically controlled in the MCE group
The rate of pylorus was magnetically controlled in the MCE group
The detection rate of gastrointestinal lesions by capsule endoscopy in two groups
Mucosal cleanliness of esophagus in two capsule endoscopy groups
Esophageal mucosa cleanliness score (Grade0: no bubbles, saliva or a small amount of bubbles, saliva, no impact on the observation of mucosa; Grade 1: moderate amount of bubbles and saliva, slight effect on observed mucosa; Grade 2: a large number of bubbles and saliva, which have a great influence on the observation of mucosa)
Mucosal cleanliness of stomach in two capsule endoscopy groups
Gastric mucosa cleanliness score:（Grade 1 : no adhesive mucus and foam, clear field of vision; Grade 2 : there is a small amount of mucus and foam, but the visual field is not blurred, which does not affect the integrity of the examination; Grade 3 : medium amount of mucus and foam, blurred visual field, affecting the integrity of the examination; Grade 4 : large amount of mucus and foam, blurred vision, affecting the integrity of the examination）
Mucosal cleanliness of small intestine in two capsule endoscopy groups
Small intestinal mucosa cleanliness score:
Small bowel cleanliness score (Grade0: no fecal residue or a small amount of clear fluid, clear field of vision; Grade 1: There is a small amount of fecal residue or more clear liquid, and the visual field is still clear, which does not affect the observation; Grade 2: More fecal residue or turbid fecal fluid, blurred vision, affecting observation)
The integrity of esophageal mucosa was observed by capsule endoscopy in the two groups
Esophageal mucosal integrity The dentate line observation was evaluated mainly, including whether the dentate line could be observed, and the number of dentate line observation quadrants;
The integrity of gastric mucosa was observed by capsule endoscopy in the two groups
Gastric mucosa integrity assessment:
The main anatomic sites such as cardia, fundus, body, Angle, antrum and pylorus were observed (grade 1: sufficient observation, ≥ 90% of gastric mucosa could be observed; Grade 2: Good observation, 70-90% of the gastric mucosa can be observed; Level 3: Insufficient observation, < 70% of gastric mucosa can be observed)
The integrity of small bowel mucosa was observed by capsule endoscopy in the two groups
The percentage of the total small bowel examination time in which the mucosa was clearly visible (> 50% visual field) was recorded
Incidence of adverse events
The rates of adverse events such as asphyxia by capsule aspiration, drug allergy and capsule retention were recorded
Overall inspection comfort score
A questionnaire survey was conducted on the overall comfort of Normal-sized CE and Mini-sized MCE, with 4 scores as very comfortable, 3 scores as comfortable, 2 scores as tolerable, 1 score as uncomfortable, and 0 score as very uncomfortable.
Full Information
NCT ID
NCT05522101
First Posted
August 4, 2022
Last Updated
October 12, 2022
Sponsor
Changhai Hospital
Collaborators
Shanghai Children's Hospital, Xian Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05522101
Brief Title
Mini-sized MCE for Detection of Small Bowel in Children Under the Age of 10 Years
Official Title
Mini-sized Magnetically Controlled Capsule Endoscopy vs. Normal-sized CE for Detection of Small Bowel in Children Under the Age of 10 Years：A Prospective，Multi-center，Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 20, 2022 (Anticipated)
Primary Completion Date
July 20, 2023 (Anticipated)
Study Completion Date
July 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital
Collaborators
Shanghai Children's Hospital, Xian Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this prospective randomized controlled trial, pediatric volunteers were enrolled and randomly underwent mini-sized MCE and normal-sized CE to compare the success rate of self-swallowing between mini-sized MCE and normal-sized CE during gastrointestinal examination.
Detailed Description
Magnetic controlled capsule endoscopy (MCE) is comparable to traditional gastroscopy (EGD) in the diagnosis of gastric diseases, and has been widely used in clinical practice. However, there are still some limitations in the application of MCE in digestive tract examination. Due to the large size of capsules at present, some patients have difficulty swallowing capsules during capsule swallowing, which leads to the failure of examination, and the proportion is higher in children patients. Therefore, in order to further improve the patient's comfort in swallowing capsules, our team developed a small MCE with a smaller size combined with innovation, which is 0.6 times of the conventional MCE in terms of volume and weight. This study aims to clarify the application efficacy of mini-MCE in gastrointestinal examination of adults and children through a multicenter clinical study comparing conventional capsule endoscopy with mini-magnetic-controlled capsule endoscopy. In order to ensure the efficacy of the capsule in the examination of digestive tract mucosa, and improve the ease of swallowing in children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Bowel Disease
Keywords
Children, Small Bowel Disease, Capsule Endoscopy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
158 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mini-sized MCE
Arm Type
Experimental
Arm Description
AKES-31SW Capsule Endoscopy
Arm Title
Normal sized CE
Arm Type
Placebo Comparator
Arm Description
PillCam Capsule Endoscopy
Intervention Type
Device
Intervention Name(s)
Mini-sized MCE
Intervention Description
AKES-31SW capsule endoscopy（Mini-sized MCE), its diameter is 9.5mm, length is 24.5mm, weight is 3.0g, shooting frequency is 0.5-6fps, image resolution is 480*480, working time is not less than 8 hours. Mini-sized MCE is 0.6 times of traditional MCE in volume and weight, which is the smallest capsule in clinical application
Intervention Type
Device
Intervention Name(s)
Normal-sized MCE
Intervention Description
Pillcam SB 3 capsule endoscopy（Normal-sized MCE), its diameter is 11.4mm, length is 26.2mm, weight is 3.0g, shooting frequency is 2-6fps, image resolution is 340*340, working time is not less than 8 hours.
Primary Outcome Measure Information:
Title
Success rate of self-swallowing with Mini-sized MCE
Description
Self-swallowing was defined as the subjects swallowing capsules for examination by themselves, and no endoscope or other instruments were needed to place capsules during the entire examination process
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Completion rate of capsule endoscopy gastric examination in two groups
Description
The stomach was divided into six parts: cardia, fundus, body, antrum, angle and pylorus. The proportion of all subjects who completed complete observation of the six anatomical parts.
Time Frame
2 weeks
Title
Completion rate of small bowel examination by capsule endoscopy in two groups
Description
Small bowel examination completion definition: All subjects reached the cecum with capsule endoscopy and completed small bowel examination.
Time Frame
2 weeks
Title
Success rate of instrument-assisted examination in the two groups
Description
The success rate of device-assisted examination was defined as the proportion of small bowel examinations performed by endoscopists using endoscope-assisted capsules.
Time Frame
2 weeks
Title
Two groups of capsule endoscopy swallowing time
Description
Swallowing time was defined as the time between the time when the patient first placed the capsule in the mouth and the time when the patient took the first image of the esophagus.
Time Frame
2 weeks
Title
Two groups of capsule endoscopy swallowing intake of water
Description
Definition of water intake in swallowing capsule: The total amount of water ingested by the subject after swallowing the capsule successfully or unsuccessfully using a measuring cup.
Time Frame
2 weeks
Title
The degree of difficulty of capsule swallowing in the two groups
Description
Swallowing difficulty is assessed on a scale of 0-5, with 0 being no difficulty and 5 being the most difficult.
Time Frame
2 weeks
Title
Factors affecting swallowing by capsule endoscopy
Description
Physiological parameter such as BMI were recorded
Time Frame
2 weeks
Title
Factors affecting gastrointestinal retention under capsule endoscopy
Description
The incidence of capsule retention due to anesthesia or intestinal obstruction was recorded
Time Frame
2 weeks
Title
The transmit time of esophagus, the transmit time of stomach, the transmit time of small intestine and the retention time of capsule in two groups
Description
The time of the first esophageal image, the first stomach image, the first small intestine image, the first large intestine image and the last image taken by capsule endoscopy were recorded.
Esophageal transmit time: time of first stomach image minus time of first esophageal image Stomach transmit time: time of first small intestine image minus time of first stomach image Small bowel transmit time: the time of the first large intestine image minus the time of the first small intestine image Total retention time of the capsule in vivo: total recording time of the capsule in vivo, which is the time of the last image of the capsule minus the time of the first image of the esophagus.
Time Frame
2 weeks
Title
The time of gastric examination was magnetically controlled in the MCE group
Time Frame
2 weeks
Title
The rate of pylorus was magnetically controlled in the MCE group
Time Frame
2 weeks
Title
The detection rate of gastrointestinal lesions by capsule endoscopy in two groups
Time Frame
2 weeks
Title
Mucosal cleanliness of esophagus in two capsule endoscopy groups
Description
Esophageal mucosa cleanliness score (Grade0: no bubbles, saliva or a small amount of bubbles, saliva, no impact on the observation of mucosa; Grade 1: moderate amount of bubbles and saliva, slight effect on observed mucosa; Grade 2: a large number of bubbles and saliva, which have a great influence on the observation of mucosa)
Time Frame
2 weeks
Title
Mucosal cleanliness of stomach in two capsule endoscopy groups
Description
Gastric mucosa cleanliness score:（Grade 1 : no adhesive mucus and foam, clear field of vision; Grade 2 : there is a small amount of mucus and foam, but the visual field is not blurred, which does not affect the integrity of the examination; Grade 3 : medium amount of mucus and foam, blurred visual field, affecting the integrity of the examination; Grade 4 : large amount of mucus and foam, blurred vision, affecting the integrity of the examination）
Time Frame
2 weeks
Title
Mucosal cleanliness of small intestine in two capsule endoscopy groups
Description
Small intestinal mucosa cleanliness score:
Small bowel cleanliness score (Grade0: no fecal residue or a small amount of clear fluid, clear field of vision; Grade 1: There is a small amount of fecal residue or more clear liquid, and the visual field is still clear, which does not affect the observation; Grade 2: More fecal residue or turbid fecal fluid, blurred vision, affecting observation)
Time Frame
2 weeks
Title
The integrity of esophageal mucosa was observed by capsule endoscopy in the two groups
Description
Esophageal mucosal integrity The dentate line observation was evaluated mainly, including whether the dentate line could be observed, and the number of dentate line observation quadrants;
Time Frame
2 weeks
Title
The integrity of gastric mucosa was observed by capsule endoscopy in the two groups
Description
Gastric mucosa integrity assessment:
The main anatomic sites such as cardia, fundus, body, Angle, antrum and pylorus were observed (grade 1: sufficient observation, ≥ 90% of gastric mucosa could be observed; Grade 2: Good observation, 70-90% of the gastric mucosa can be observed; Level 3: Insufficient observation, < 70% of gastric mucosa can be observed)
Time Frame
2 weeks
Title
The integrity of small bowel mucosa was observed by capsule endoscopy in the two groups
Description
The percentage of the total small bowel examination time in which the mucosa was clearly visible (> 50% visual field) was recorded
Time Frame
2 weeks
Title
Incidence of adverse events
Description
The rates of adverse events such as asphyxia by capsule aspiration, drug allergy and capsule retention were recorded
Time Frame
2 weeks
Title
Overall inspection comfort score
Description
A questionnaire survey was conducted on the overall comfort of Normal-sized CE and Mini-sized MCE, with 4 scores as very comfortable, 3 scores as comfortable, 2 scores as tolerable, 1 score as uncomfortable, and 0 score as very uncomfortable.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients and their legal guardians agreed to participate in the study and signed informed consent;
2 years ≤ age < 10 years;
Pediatric patients with suspected small bowel disease who are scheduled for small bowel capsule endoscopy
Exclusion Criteria:
Intestinal obstruction, stenosis, or fistula is known or suspected;
Dysphagia or gastric emptying dysfunction;
Severe asthma, dysphagia or gastroparesis and other emptying disorders;
Known or suspected possibility of major bleeding from active digestive tract;
The presence of a pacemaker in the body, except where the pacemaker is a new MRI-compatible product;
Implanted cochlear implants, magnetic metal drug infusion pumps, nerve stimulators and other electronic devices, as well as magnetic metal foreign bodies;
Those who plan to undergo magnetic resonance imaging (MRI) examination before capsule endoscopy discharge;
Previous history of abdominal surgery affecting the normal structure of the digestive tract;
Patients with mental illness;
Allergic to macromolecular materials such as dimethyl silicone oil;
Refuse to use electronic gastroscopy to deliver the capsule to the duodenum if the capsule cannot be swallowed by itself;
Contraindications of intravenous anesthesia;
Patients who have participated in or are participating in other clinical trials within three months;
Any other factors considered by the investigator to be inappropriate for enrollment or to affect the participant's participation in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhuan Liao
Phone
86-21-31161004
Email
liaozhuan@smmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhuan Liao
Organizational Affiliation
Changhai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qilu Children's Hospital
City
Jinan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junjie Xu
Facility Name
Shanghai Changhai Hospital
City
Shanghai
Country
China
Facility Name
Shanghai Children's Hospital
City
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haifeng Liu
Facility Name
Xi'an Children's Hospital
City
Xi'an
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Fang
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
After finishing this study,We will make the data available to other researchers:including protocol,statistical analysis plan (SAP),informed consent form (ICF) and clinical study report (CSR).
IPD Sharing Time Frame
3 years
IPD Sharing Access Criteria
The website of the journal where the results published,and ClinicalTrials.gov web site.
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Learn more about this trial
Mini-sized MCE for Detection of Small Bowel in Children Under the Age of 10 Years
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