Mini-sized MCE for Detection of Small Bowel in Children Under the Age of 10 Years
- Conditions
- Small Bowel Disease
- Interventions
- Device: Mini-sized MCEDevice: Normal-sized MCE
- Registration Number
- NCT05522101
- Lead Sponsor
- Changhai Hospital
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 158
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mini-sized MCE Mini-sized MCE AKES-31SW Capsule Endoscopy Normal sized CE Normal-sized MCE PillCam Capsule Endoscopy
- Primary Outcome Measures
Name Time Method Success rate of self-swallowing with Mini-sized MCE 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 Outcome Measures
Name Time Method The degree of difficulty of capsule swallowing in the two groups 2 weeks Swallowing difficulty is assessed on a scale of 0-5, with 0 being no difficulty and 5 being the most difficult.
Completion rate of capsule endoscopy gastric examination in two groups 2 weeks 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 2 weeks 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 2 weeks 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 2 weeks 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 2 weeks 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 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 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 2 weeks 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 2 weeks 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 2 weeks 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 2 weeks 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 2 weeks 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 2 weeks The rates of adverse events such as asphyxia by capsule aspiration, drug allergy and capsule retention were recorded
Overall inspection comfort score 2 weeks 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.
Factors affecting swallowing by capsule endoscopy 2 weeks Physiological parameter such as BMI were recorded
Factors affecting gastrointestinal retention under capsule endoscopy 2 weeks 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 2 weeks 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.
Trial Locations
- Locations (4)
Qilu Children's Hospital
🇨🇳Jinan, China
Shanghai Changhai Hospital
🇨🇳Shanghai, China
Xi'an Children's Hospital
🇨🇳Xi'an, China
Shanghai Children's Hospital
🇨🇳Shanghai, China