Application Of Small-sized Magnetically Controlled Capsule Endoscopy In Adults And Children

Part I Small-sized versus standard magnetic capsule endoscopy in adults: a two-center,randomized controlled trialAims: The newly developed small-sized magnetically controlled capsule endoscopy(MCE)device is the smallest CE device ever reported.We aimed to evaluate the performance of the small-sized MCE device in terms of ingestion and examination efficacy.Methods: Patients in two centers were prospectively enrolled and randomized to the small-sized or standard MCE groups.The difference in capsule ingestion difficulties,visualization of gastrointestinal tract,detection rate of lesions,capsule transit times in gastrointestinal examination as well as safety evaluation were compared.Results:(1)From January 2021 to May 2021,a total of 96 consecutive patients(48 in each group)aged 24 to 79 years were enrolled from Changhai Hospital and Qilu Hospital,and all patients completed the study.Baseline characteristics of the patients were shown no statistical difference between the two groups.(2)In small-sized MCE group,the consumed time,difficulty score and one time success rate of swallowing the capsule were 3.44±1.25 s,0.63±1.04,89.58%,a significant improvement from those in standard MCE group with11.96±14.27 s,3.08±1.65 and 60.42%(all P<0.001).(3)The rate of Z-line detection,complete gastric anatomical structures detection and complete small bowel examination were comparable in small-sized and standard MCE groups(60.42% vs 64.58%;100% vs100%;97.92% vs 100%).(4)The small-sized MCE group had significantly shorter gastric transit time(49.43 min vs 66.23 min,P=0.039)and longer small bowel transit time(5.75 h vs5.02 h,P=0.045).(5)There were no significant differences in the detection of lesions between the two groups,and one esophagus cancer were detected under small-sized MCE.(6)No adverse events such as capsule retention and aspiration occurred.Conclusions: The small-sized MCE is feasible and safe for upper gastrointestinal tract and small bowel examination,greatly alleviating the difficulties in capsule ingestion and made it easier for gastric emptying under magnetic control.Part II Small-sized magnetic capsule endoscopy vs.standard capsule endoscopy for detection of small bowel in infant and children under the age of 10 years:a preliminary clinical trialAims: The purpose of this study was to evaluate the performance of the small-sized MCE device in terms of ingestion and examination efficacy in children.Methods: In three medical centers,patients aged 2 years or older and younger than 10 years with suspected small bowel disease were eligible for this study.These patients were prospectively enrolled and randomly allocated into the standard CE group or small-sized MCE group in a 1:1 ratio.The difference in capsule ingestion difficulties,visualization of gastrointestinal tract,detection rate of lesions,capsule transit times in gastrointestinal examination as well as safety evaluation were compared.Results:(1)From November 2022 to March 2023,a total of 20 consecutive patients(10 in each group)aged 4 to 9 years were enrolled from Changhai Hospital and Xi ’an Children’s Hospital and Shanghai Children’s Hospital,and 19 subjects were finished smallsized MCE or standard CE examination.Baseline characteristics of the patients were shown no statistical difference between the two groups.(2)In small-sized MCE group,the one time success rate of swallowing the capsule,number of swallows,difficulty score and the consumed time were 80%,1.20±0.42,0.40±0.70 and 5.00s(IQR,3.00-28.50s),a significant improvement from those in standard CE group with 30%,2.10±0.99,2.20±1.69 and 27.50s(IQR,10.00-79.25s)(all P<0.05).(3)The rate of Z-line detection and complete small bowel examination were comparable in small-sized and standard CE groups(10% vs.10%;100%vs.90%).(4)The esophageal transit time(3.50±2.72 s vs.3.77±2.86 s,P=0.831),gastric transit time [27.50 min(IQR,10.00-79.25min)vs.19.40 min(IQR,12.60-69.00min),P=0.050] and small bowel transit time(5.26±0.68 h vs.6.08±2.47 h,P=0.324)were comparable in small-sized and standard CE groups.(5)There was no significant difference in detection of small bowel lesions,and two stomach mucosa erosion,one duodenitis and one duodenal mucosa atrophy were detected under small-sized MCE.(6)One patient in the standard CE group failed to swallow the capsule and chose to place the capsule through endoscope,resulting in mucosal injury during the operation.Conclusions: Small-sized MCE is safe and feasible for the examination of upper gastrointestinal tract and small intestine,and can improve the one time success rate of swallowing,reduce the number of swallowing attempts,and lower the degree of difficulty in swallowing in children.