Dataset Information

Standing-type magnetically guided capsule endoscopy versus gastroscopy for gastric examination: multicenter blinded comparative trial.

ABSTRACT: AIM:To compare feasibility and safety after gastrointestinal checkup by standing-type magnetically controlled capsule endoscopy (SMCE) and conventional gastroscopy. METHODS:This was a prospective multicenter, blinded study that compared SMCE with gastroscopy in patients from April 2018 to July 2018. All patients first underwent SMCE and then subsequently had gastroscopy with i.v. anesthesia. We calculated the compliance rates of gastric lesion detection by SMCE using gastroscopy as the standard. Capsule retention rate, incidence of adverse events, and patient satisfaction were documented throughout the study. RESULTS:One hundred and sixty-one patients who completed SMCE and gastroscopy were included in the analysis. Positive compliance rate among SMCE and gastroscopy was 92.0% (95% CI: 80.77%-97.78%). Negative compliance rate was 95.5% (89.80%, 98.52%). Moreover, overall compliance rate was 94.41% (89.65%, 97.41%). Sixty-four pathological outcomes were identified. Of these 64 outcomes, 50 were detected by both procedures. The gastroscopy method neglected seven findings (such as five erosions, one polyp, and one ulcer). Furthermore, SMCE also overlooked seven lesions (i.e. one erosion, two polyps, one atrophy, and three submucosal tumors). Capsule retention or related adverse events were not reported. CONCLUSION:Standing-type magnetically controlled capsule endoscopy provides equivalent agreement with gastroscopy and may be useful for screening of gastric illnesses without any anesthesia.

SUBMITTER: Lai HS

PROVIDER: S-EPMC7318584 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Standing-type magnetically guided capsule endoscopy versus gastroscopy for gastric examination: multicenter blinded comparative trial.

Lai Hua-Sheng HS Wang Xin-Ke XK Cai Jian-Qun JQ Zhao Xin-Mei XM Han Ze-Long ZL Zhang Jie J Chen Zhen-Yu ZY Lin Zhi-Zhao ZZ Zhou Ping-Hong PH Hu Bing B Li Ai-Min AM Liu Si-de SD

Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society 20191010 4

<h4>Aim</h4>To compare feasibility and safety after gastrointestinal checkup by standing-type magnetically controlled capsule endoscopy (SMCE) and conventional gastroscopy.<h4>Methods</h4>This was a prospective multicenter, blinded study that compared SMCE with gastroscopy in patients from April 2018 to July 2018. All patients first underwent SMCE and then subsequently had gastroscopy with i.v. anesthesia. We calculated the compliance rates of gastric lesion detection by SMCE using gastroscopy a ...[more]

PMID: 31483889

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Project description:BACKGROUND:Current magnet-controlled capsule endoscopy (MCE) for the stomach is not yet satisfactory with respect to navigation control, especially in the gastric fundus and cardia. A newly developed MCE system conducted in a standing rather than supine position may improve capsule maneuverability within the stomach. The aim of this phase 1 study was to assess the feasibility and safety of this system for examining the human stomach in healthy volunteers. METHODS:A cohort of 31 healthy volunteers were enrolled. Each swallowed a capsule after drinking water and gas producing agents intended to produce distention. Under the newly developed standing MCE system, subjects were examined endoscopically while standing with external guide magnets placed on the abdominal wall and left lower chest. Safety, gastric preparation, maneuverability, visualization of anatomical landmarks and the gastric mucosa, and examination time were the primary parameters assessed. The gastric preparation and examination procedures were well accepted by the subjects and there were no adverse events. RESULTS:Gastric examination took 27.8?±?8.3?min (12-45?min). Gastric cleanliness was good in 24 participants (77.4%) and moderate in 7 participants (22.6%). Gastric distention was good in all of 31 participants (100%). Capsule maneuverability was also graded as good in all 31 subjects (100%), and manipulation in the fundus and cardia regions was as easy as that in the antrum and body. Visualization of the gastric cardia, fundus, body, angulus, antrum and pylorus was assessed subjectively as complete in all 31 subjects (100%). Visualization of the gastric mucosa was also good (>?75%) in all 31 subjects (100%). In areas where the mucosa could not be visualized, the low visibility was due to opaque fluid or foam. Polyps and erosive lesions were found in 25 subjects. CONCLUSION:MCE of the stomach conducted in a standing position is feasible and safe with satisfactory maneuverability.

Project description:BackgroundGastroesophageal varices is a serious complication of compensated advanced chronic liver disease (cACLD). Primary prophylaxis to reduce the risk of variceal hemorrhage is recommended if high-risk varices (HRV) are detected. We performed this study to compare the accuracy, patients' satisfaction and safety of detection of HRV by detachable string magnetically controlled capsule endoscopy (DS-MCCE) with esophagogastroduodenoscopy (EGD) as the reference.MethodsWe prospectively recruited participants with cACLD from 12 university hospitals (11 in China and one in the United Kingdom) between November 2018 and December 2019 (ClinicalTrials.gov, NCT03749954). All participants underwent DS-MCCE, followed by EGD within a week in a blinded fashion. Following endoscopy, and on the same day, participants were asked to fill in a satisfaction questionnaire regarding their experience.FindingsA total of 105 eligible participants were enrolled. With EGD as the reference standard, the concordance index, sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio of DS-MCCE in diagnosis of HRV were 0•90 (95% confidence interval [CI]: 0•83-0•95), 92% (95% CI: 78-98%), 88% (95% CI: 78-95%), 80% (95% CI: 70-92%), 95% (95% CI: 90-100%), 7•91 (95% CI: 4•10-15•30), and 0•09 (95% CI: 0•03-0•30), respectively. The kappa score of 0•78 (95% CI: 0•65-0•90) suggested substantial agreement between DS-MCCE and EGD. Moreover, in participants undergoing EGD without sedation, the satisfaction of DS-MCCE was significantly better than that of EGD (p < 0•0001, d = 1•15 [95%CI: 0•88-1•42]). All participants confirmed the excretion of the capsule, and no adverse events occurred.InterpretationDS-MCCE is an accurate alternative to EGD for detecting HRV in cACLD, which is safe and associated with better satisfaction.FundingA full list of funding can be found in the Funding Support section.

Project description:To assess the cleansing efficacy and safety of a new Colon capsule endoscopy (CCE) bowel preparation regimen.This was a multicenter, prospective, randomized, controlled study comparing two CCE regimens. Subjects were asymptomatic and average risk for colorectal cancer. The second generation CCE system (PillCam® COLON 2; Medtronic, Yoqneam, Israel) was utilized. Preparation regimens differed in the 1st and 2nd boosts with the Study regimen using oral sulfate solution (89 mL) with diatrizoate meglumine and diatrizoate sodium solution ("diatrizoate solution") (boost 1 = 60 mL, boost 2 = 30 mL) and the Control regimen oral sulfate solution (89 mL) alone. The primary outcome was overall and segmental colon cleansing. Secondary outcomes included safety, polyp detection, colonic transit, CCE completion and capsule excretion ? 12 h.Both regimens had similar cleansing efficacy for the whole colon (Adequate: Study = 75.9%, Control = 77.3%; P = 0.88) and individual segments. In the Study group, CCE completion was superior (Study = 90.9%, Control = 76.9%; P = 0.048) and colonic transit was more often < 40 min (Study = 21.8%, Control = 4%; P = 0.0073). More Study regimen subjects experienced adverse events (Study = 19.4%, Control = 3.4%; P = 0.0061), and this difference did not appear related to diatrizoate solution. Adverse events were primarily gastrointestinal in nature and no serious adverse events related either to the bowel preparation regimen or the capsule were observed. There was a trend toward higher polyp detection with the Study regimen, but this did not achieve statistical significance for any size category. Mean transit time through the entire gastrointestinal tract, from ingestion to excretion, was shorter with the Study regimen while mean colonic transit times were similar for both study groups.A CCE bowel preparation regimen using oral sulfate solution and diatrizoate solution as a boost agent is effective, safe, and achieved superior CCE completion.

Dataset Information

Standing-type magnetically guided capsule endoscopy versus gastroscopy for gastric examination: multicenter blinded comparative trial.

Publications

Standing-type magnetically guided capsule endoscopy versus gastroscopy for gastric examination: multicenter blinded comparative trial.

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