A Randomized Controlled Trial Of Three Different Regimens Of Gastric Preparation For Magnetic-controlled Capsule Endoscopy

Objective:To investigate an optimal standardized gastric preparation regimen for magnetic-controlled capsule endoscopy(MCE)by comparing the effects of the various methods on the image quality of stomach,patients' tolerance,gastric positive lesions and safety outcome through a randomized controlled trial.Methods:120 patients referred for MCE in Changhai Hospital from June to October 2016 were enrolled and analyzed.All patients reached the hospital in the morning after overnight fasting(>8 hours).They were randomly assigned to three preparation groups:(A)water control group;(B)simethicone group;or(C)simethicone combined with pronase group(S-P group).All patients required to drink different agents 50 minutes before the examination.Primary end point was the image quality including cleanliness and visualization of gastric mucosa.The image quality including cleanliness and visualization of gastric mucosa was assessed by an MCE endoscopist blinded to patients' allocation.The patients' tolerance,gastric lesions and safety outcome gastric lesions were also analyzed.Result: 1.120 patients were included with 72 males and 48 females.The average age was 53 males and 37 female with a mean age of 47.05 years(range,20-74 y).The average Body Mass Index(BMI)was 23.04±3.88 kg/m2 and average waistline was 82.37±11.31 cm.There are no significant difference in age,gender,BMI and waistline among the three investigated groups(P>0.05).In addition,among the 120 patients,there were 53 case with abdominal pain complaint,14 case with abdominal distension complaint,12 case with acid reflux or nausea or vomit,9 case with OGIB or IDA and 32 case with health examination.2.Primary outcome: the quality of MCE videos.To evaluate the quality of MCE videos,scores of gastric cleanliness and mucosal visualization in six primary anatomic landmarks of the stomach(cardia,fundus,body,angulus,antrum,and pylorus)were recorded.The total cleanliness score(mean ± SD)was 15.83±2.41 in group A,21.35±1.23 in group B,and 20.82±1.90 in group C.The total visualization score(mean ± SD)was 10.75±2.02 ingroup A,15.20±1.32 in group B,and 15.08±1.86 in group C.While the image quality of the whole stomach in groups B and C were significantly better than group A(P <0.0001),there is no statistical difference between group B and C(P>0.05).As for positive findings,MCE detected 21(52.5%),27(67.5%)and 21(53.8%)patients in group A,B and C,respectively,and no significant difference existed among the three groups(P>0.5).3.Secondary outcome:as for positive findings in the stomach,21(52.5%),27(67.5%),21(53.8%),patients were diagnosed with superficial gastritis,chronic erosive gastritis,polyps or gastric ulcer in group A,group B and group C,respectively.No significant difference existed among the three groups.One gastric malignant ulcer was detected by MCE in group A and was later confirmed by conventional gastroscopy and biopsy.Pathologic result suggested that it was advanced signet-ring cell carcinoma.The patient died 2 months later.4.Safety outcomes: all patients swallowed the MCE spontaneously.Only one patient reported capsule retention because of pyloric inflammatory edema and the capsule had to be removed by conventional gastroscopy.Therefore,complications occurred only in one case(0.8%).No other adverse event was reported during the examination procedure and 2 weeks following-up.Conclusion: Simethicone proved to improve the image quality of the gastric mucosa before MCE.Since adding pronase didn't prominently improve the image quality,we recommended administration of simethicone with water as a better gastric preparation for MCE.