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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Changhai Hospital
- Enrollment
- 158
- Locations
- 4
- Primary Endpoint
- Success rate of self-swallowing with Mini-sized MCE
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 9 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Mini-sized MCE
AKES-31SW Capsule Endoscopy
Intervention: Mini-sized MCE (Device)
Normal sized CE
PillCam Capsule Endoscopy
Intervention: Normal-sized MCE (Device)
Outcomes
Primary Outcomes
Success rate of self-swallowing with Mini-sized MCE
Time Frame: 2 weeks
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 Outcomes
- Completion rate of capsule endoscopy gastric examination in two groups(2 weeks)
- Completion rate of small bowel examination by capsule endoscopy in two groups(2 weeks)
- Success rate of instrument-assisted examination in the two groups(2 weeks)
- Two groups of capsule endoscopy swallowing time(2 weeks)
- Two groups of capsule endoscopy swallowing intake of water(2 weeks)
- The degree of difficulty of capsule swallowing in the two groups(2 weeks)
- The time of gastric examination was magnetically controlled in the MCE group(2 weeks)
- The rate of pylorus was magnetically controlled in the MCE group(2 weeks)
- The detection rate of gastrointestinal lesions by capsule endoscopy in two groups(2 weeks)
- Mucosal cleanliness of esophagus in two capsule endoscopy groups(2 weeks)
- Mucosal cleanliness of stomach in two capsule endoscopy groups(2 weeks)
- Mucosal cleanliness of small intestine in two capsule endoscopy groups(2 weeks)
- The integrity of esophageal mucosa was observed by capsule endoscopy in the two groups(2 weeks)
- The integrity of gastric mucosa was observed by capsule endoscopy in the two groups(2 weeks)
- The integrity of small bowel mucosa was observed by capsule endoscopy in the two groups(2 weeks)
- Incidence of adverse events(2 weeks)
- Overall inspection comfort score(2 weeks)
- Factors affecting swallowing by capsule endoscopy(2 weeks)
- Factors affecting gastrointestinal retention under capsule endoscopy(2 weeks)
- 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(2 weeks)
Investigators
Zhuan Liao
Professor
Changhai Hospital