Gastric Media Composition Optimization Study Of Magnetically Controlled Capsule Endoscopy

The diseases distributed in the both stomach and small intestine are commonly seen,while the step-by-step strategy of gastroscopy followed enteroscopy can be burdensome and costly.Magnetically controlled capsule endoscopy(MCE),with equally favorable diagnostic accuracy as conventional endoscopy,has become a painless noninvasive diagnostic modality in clinical practice,and the battery life of the MCE is more than 8 hours,which enables a further examination of the small bowel,and thus improve the efficiency of the examination of the stomach and small intestine.Gastric preparation of MCE involves two key processes: gastric distension and gastric cleansing.Good gastric preparation is the basis of magnetically controlled capsule endoscopy(MCE)examination and gastric emptying of MCE affects the integrity of the small bowel examination.However,the recommended gastric preparation of simethicone to clean the stomach cavity and a large amount of water to fill the stomach cavity has certain deficiencies in practical clinical application.The exisiting problems include a lot of residual mucus in the stomach,feeling of bloating,and the delayed gastric emptying of capsule due to excessive drinking water.These would lead to an incomplete gastro-small intestine joint examination.Since the usage of MCE in one-time gastro-small intestine joint examination have never been discussed in previous studies,we aimed to explore its success rate,diagnostic yield,visualization and shortcomings in this retrospective study.Soda-water can release carbon dioxide and fill the stomach cavity in a combination of liquid and gas,so that the subjects can get better gastric distension while reducing the water intake.In the second part,we aimed to explore the feasibility and efficacy of Sprite Zero in gastric preparation for MCE.Besides,in order to improve the quality of gastric preparation,we proposed a new premedication method combining simethicone,pronase and double dose of sodium bicarbonate.Then,a clinical randomized controlled trial was carried out to compare the effect of the new premedication method for gastric visualization of MCE.Part I: Magnetically controlled capsule endoscopy in the one-time gastro-small intestinal joint examinationStudy aims: The aim of this study was to assess the success rate and efficacy of one-time gastro-small intestinal joint examination under MCE.Methods: Data from MCE database of the First Medical Center of PLA General Hospital and Changhai Hospital between January 2020 to August 2021 were enrolled in the study consecutively.All recruited participants underwent combined UGI and small intestine examination under MCE.Baseline characteristics and MCE related parameters including the visualization of digestive tract,cleanliness of digestive tract,gastrointestinal transit time,total recording time(TRT),capsule endoscopy completion rate,diagnostic yield(DY)and safety outcome would be analyzed.Results:(1)During January 2020 and August 2021,735 participants were retrospectively recruited to the study cohort.(2)Among these participants,36 patients haven’t completed a comprehensive stomach examination.Success rate of small intestinal examination was 97.28%,with MCE failed to reach the caecum in 20 participants.Overall,the success rate of one-time gastro-small intestinal joint examination achieved 92.79%.(3)Visualization of esophagus mucosa was achieved in 716 participants(97.41%).The median number of captured pictures of esophagus were 68(IQR,40-128).(4)Visualization of gastric mucosa in 711 participants(96.73%)achieved grade 1.There are 2.86% and 0.41% participants achieved grade 2 and grade3,respectively.(5)For small intestine,77.82%,20.27% participants were detected more than75%,50%-75% of small intestine mucosa,respectively.(6)The median ETT and GET of MCE was 17.00 s(IQR,10.00-32.00 s)and 8.13min(IQR,6.50-10.25min),respectively.The median PTT was 54.75min(IQR,22.12-93.38min),and GTT was 64.93min(IQR,32.42-102.07min).In the small intestine,SBTT of MCE was 4.92h(IQR,3.91-6.20h).For total examination,the median TRT was 12.83h(IQR,12.21-13.36h).Transpyloric passage of MCE under magnetic control was successfully steered preformed in 179 participants(24.35%).(7)For pathological lesions found by MCE in this examination,35 lesions were detected in esophagus.Lesions in stomach were found in 726 participants.Sixty participants with duodenum diseases were detected by MCE.There were 117 participants diagnosed with small intestine diseases.Positive lesions in both stomach and small intestine were 82.(8)For safety assessment,there were 2 cases of capsule retention in 735 subjects,both were retained in the small intestine,one capsule was discharged spontaneously after treatment,and the other was taken out by enteroscopy.No obvious adverse events were observed in the remaining patients.Conclusion: The success rate of one-time gastro-small intestinal joint examination under MCE is high,and the procedure is safe and effective.Some patients have incomplete gastric and small bowel examinations,and further studies are warranted to further optimize the examination performance.Part II: Gastric emptying with sparkling water for magnetically controlled capsule endoscopyStudy aims: This study aimed to explore the feasibility and efficacy of sparkling water in gastric emptying for MCE.Methods: Since it was the first time to apply sparkling water in gastric preparation procedure for MCE,the study was conducted in two steps,including a pre-experiment and a large sample randomized controlled study based on the results of the pre-experiment.The patients were randomly divided to sparkling wate group and control group in 1:1 ratio.For patients in control group,800-1000 m L water would be taken to distend the stomach.And for patients in the sparkling water group,400 ml sparkling water were provided for gastric distension.The primary endpoint was gastric distension score which was evaluated at 0-5 min,5-10 min and 10-15 min after the capsule entered the stomach.Secondary endpoint included the feeling of fullness,GTT,small bowel transit time(SBTT),gastric examination time(GET),completion rate(CR)for small bowel examination and diagnostic yield(DY).Results:(1)A total of 102 patients in the pre-experiment were included in the final analysis(52 in the sparkling water group and 50 in the control group).In sparkling water group,the median score of gastric distension maintained at 4 with less total liquid consumption(500ml vs.900 ml,P<0.0001),lower feeling of fullness score(7.0 vs 7.5,P=0.047)and higher proportion of patients with GTT less than 30 minutes(69.57% vs 27.59%,P=0.03)than control group.The CR of small bowel examination in sparkling water group was 100%,higher than86.99% of the control group(P=0.245).(2)In the large sample,randomized controlled study,a total of 252 patients aged 18 to 77 years were included,with 126 cases in each group.The gastric distension score was ≥4 in 123 patients in sparkling water group and 101 in control group(97.62% vs.80.16%,P<0.0001).The median gastric distension score in sparkling water group was 5.0(IQR,5.0-5.0)in 0-5 minutes after the capsule entered the stomach,which was higher than 5.0(IQR,4.0-5.0)in control group(P<0.001).The median gastric distension score in group sparkling water was 4.0(IQR,4.0-5.0)in 5-10 minutes after the capsule entered the stomach,which was higher than 4.0(IQR,3.0-4.0)in control group(P<0.001).During the examination procedure,21 patients in control group required extra fluid for gastric distension,which was significantly higher than that in sparkling water group of 2 patients(21vs.2,P<0.001).The GTT in sparkling water group was shorter than that in control group(53.27 min vs.71.12 min,P=0.001).There was no significant difference in the feeling of fullness score(7.85 vs.7.72,P=0.551)between sparkling water and control groups(2.0 vs.2.0,P=0.882).The gastric transit time of sparkling water group was significantly lower than that of control group(53.27 min vs.71.12 min,P=0.001).Conclusions: Compared with 800 ml water,400 ml sparkling water not only can fully distend the stomach,but also makes patients feel more comfortable.It has the potential to accelerate gastric emptying and improve the CR of small bowel examination.Part III: Premedication with simethicone,pronase and sodium bicarbonate for magnetically controlled capsule endoscopy: an in vitro and in vivo studyStudy aims: Firstly,the effects of different ratios of simethicone,pronase,sodium bicarbonate and different reaction times on the cleaning efficacy of gastric bubble and mucus were compared in vitro experiments.On the basis of the vitro experiment,the best premedication protocol for clearing bubble and mucus was selected.Then,a clinical randomized controlled trial was carried out to explore whether the new gastric preparation methods could optimize the gastric mucosal visualization for MCE examination.Methods:(1)In the vitro test.The gastric juices of 10 subjects with poor overall gastric cleanliness score during MCE examination were collected,and different gastric preparation specimen were prepared according to different ratio of simethicone,pronase and sodium bicarbonate.Then,various prepared gastric fluids were added to the standard gastric juice.We record the bubble content,mucus content,turbidity score and overall cleanliness score of gastric juice after 0 minutes-60 minutes of reaction.On this basis,the optimal gastric preparation ratio of simethicone,pronase and sodium bicarbonate and reaction time were selected.(2)In the clinical randomized controlled trial.290 subjects who underwent magnetically controlled capsule endoscopy were included and randomly divided into 2 groups in 1:1 ratio.The experimental group underwent the new gastric preparation methods(take simethicone 60 minutes before the examination combined with pronase and 2g sodium bicarbonate 20 minutes before the examination).The overall cleanliness of gastric mucosa,the observation of small intestinal mucosa,relevant examination times,the detection of lesions,adverse events and other indicators were recorded,and the data were statistically interpreted.Results:(1)In the vitro test.It showed that the combination of 2.5g simethicone,20000 IU pronase,2g sodium bicarbonate was the best gastric preparation protocol.(2)In the clinical randomized controlled trial.(1)A total of 290 subjects who underwent combined gastrointestinal examination under MCE were randomly enrolled,with 145 subjects in each group.There was no significant difference between the two groups in baseline characteristics.(2)The score of gastric mucosa cleanliness: The total score of gastric cleanliness in the experimental group and the control group was 23.48±0.75 and 21.92±1.89 respectively(P<0.001),and the gastric cleanliness of the experimental group was significantly better.In the experimental group and the control group,the median cleanliness score of the cardia was 4.0(4.0-4.0)vs.4.0(3.0-4.0),(P < 0.001);the median cleanliness score of the fundus was 4.0(4.0-4.0)vs.4.0(3.0-4.0),(P <0.001);the median cleanliness score of the gastric body was 4.0(4.0-4.0)vs.4.0(3.0-4.0),(P <0.001);the median cleanliness scores of gastric antrum,gastric angle and pylorus in both groups were all 4.0(4.0-4.0),there was no significant difference between the two groups.(3)The complete observation rate of the whole gastric mucosa was 92.41% in the experimental group and 88.28% in the control group(P=0.233).In the experimental group and the control group,the complete observation rate of gastric fundus was 96.55% vs.90.34%,P=0.033.There was no significant difference in the complete observation rate of gastric cardia,body,antrum,gastric angle and pylorus.(4)Observation of small intestinal mucosa showed that there was no significant difference between the experimental group and the control group in the scores of proximal and middle intestinal mucosal cleanliness(P=0.154,P=0.098).The median score of the distal small intestinal mucosal cleanliness of the experimental group was 0.00(0.00-1.00),which was better than that of the control group by 1.00(0.00-1.00)(P=0.017).There was no significant difference between the test group and the control group in the scores of the proximal,middle and distal small intestine bubbles.There was no significant difference between the two groups in the clear visualization proportion of the small intestine(P=0.274).(5)There were no significant differences between the experimental group and the control group in the transmit time of esophagus,stomach and small intestine,capsule working time and small intestine examination completion rate.The gastric examination time of the experimental group was significantly lower than that of the control group(7.99±2.54 vs.11.20±8.32,P<0.001).(6)There was no significant difference between the test group and the control group in the examination rate of esophagus,stomach and small intestine lesions.Conclusions: The new gastric preparation protocol of taking simethicone 60 minutes before the examination and taking pronase and 2g sodium bicarbonate 20 minutes before the examination can enhence the cleanliness of the gastric fundus,gastric cardia and gastric body,reduce the gastric examination time,and improve examination effectiveness of MCE.