Mini-sized MCE for Detection of Small Bowel in Children Under the Age of 10 Years

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Small Bowel Disease

Intervention / Treatment
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* Device: Mini-sized MCE
* Device: Normal-sized MCE


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mini-sized MCE<br>AKES-31SW Capsule Endoscopy | Device: Mini-sized MCE<br>* 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<br>|
| Placebo Comparator: Normal sized CE<br>PillCam Capsule Endoscopy | Device: Normal-sized MCE<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 weeks | 
| 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. | 2 weeks | 
| 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. | 2 weeks | 
| 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. | 2 weeks | 
| 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. | 2 weeks | 
| 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. | 2 weeks | 
| Factors affecting swallowing by capsule endoscopy | Physiological parameter such as BMI were recorded | 2 weeks | 
| Factors affecting gastrointestinal retention under capsule endoscopy | The incidence of capsule retention due to anesthesia or intestinal obstruction was recorded | 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 | 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. | 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 | 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) | 2 weeks | 
| 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） | 2 weeks | 
| 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) | 2 weeks | 
| 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; | 2 weeks | 
| 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) | 2 weeks | 
| 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 | 2 weeks | 
| Incidence of adverse events | The rates of adverse events such as asphyxia by capsule aspiration, drug allergy and capsule retention were recorded | 2 weeks | 
| 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. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Small Bowel Disease, Capsule Endoscopy