Clinical trial NCT05522101: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Small Bowel Disease
Keywords: Children
Small Bowel Disease
Capsule Endoscopy
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Children's Hospital
name: Xian Children's Hospital
First posted: 2022-08-30
Enrollment: 158
Sex: ALL
Minimum age (years): 2
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Success rate of self-swallowing with Mini-sized MCE
timeFrame: 2 weeks
Secondary outcomes:
measure: Completion rate of capsule endoscopy gastric examination in two groups
timeFrame: 2 weeks
measure: Completion rate of small bowel examination by capsule endoscopy in two groups
timeFrame: 2 weeks
measure: Success rate of instrument-assisted examination in the two groups
timeFrame: 2 weeks
measure: Two groups of capsule endoscopy swallowing time
timeFrame: 2 weeks
measure: Two groups of capsule endoscopy swallowing intake of water
timeFrame: 2 weeks
measure: The degree of difficulty of capsule swallowing in the two groups
timeFrame: 2 weeks
measure: Factors affecting swallowing by capsule endoscopy
timeFrame: 2 weeks
measure: Factors affecting gastrointestinal retention under capsule endoscopy
timeFrame: 2 weeks
measure: 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
timeFrame: 2 weeks
measure: The time of gastric examination was magnetically controlled in the MCE group
timeFrame: 2 weeks
measure: The rate of pylorus was magnetically controlled in the MCE group
timeFrame: 2 weeks
measure: The detection rate of gastrointestinal lesions by capsule endoscopy in two groups
timeFrame: 2 weeks
measure: Mucosal cleanliness of esophagus in two capsule endoscopy groups
timeFrame: 2 weeks
measure: Mucosal cleanliness of stomach in two capsule endoscopy groups
timeFrame: 2 weeks
measure: Mucosal cleanliness of small intestine in two capsule endoscopy groups
timeFrame: 2 weeks
measure: The integrity of esophageal mucosa was observed by capsule endoscopy in the two groups
timeFrame: 2 weeks
measure: The integrity of gastric mucosa was observed by capsule endoscopy in the two groups
timeFrame: 2 weeks
measure: The integrity of small bowel mucosa was observed by capsule endoscopy in the two groups
timeFrame: 2 weeks
measure: Incidence of adverse events
timeFrame: 2 weeks
measure: Overall inspection comfort score
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Children's Hospital
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
city: Shanghai
country: China
facility: Shanghai Children's Hospital
city: Xi'an
country: China
facility: Xi'an Children's Hospital
Study officials:
affiliation: Changhai Hospital
name: Zhuan Liao
role: PRINCIPAL_INVESTIGATOR
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