title: Accuracy of Magnetically Controlled Capsule Endoscopy, Compared With Conventional Gastroscopy, in Detection of Gastric Diseases.
abstract: Diseases of the stomach, including gastric cancer and peptic ulcer, are the most common digestive diseases. It is impossible to visualize the entire stomach with the passive capsule currently used in practice because of the large size of the gastric cavity. A magnetically controlled capsule endoscopy (MCE) system has been designed to explore the stomach. We performed a prospective study to compare the accuracy of detection of gastric focal lesions by MCE vs conventional gastroscopy (the standard method).
  
  
  
  We performed a multicenter blinded study comparing MCE with conventional gastroscopy in 350 patients (mean age, 46.6 y), with upper abdominal complaints scheduled to undergo gastroscopy at a tertiary center in China from August 2014 through December 2014. All patients underwent MCE, followed by conventional gastroscopy 2 hours later, without sedation. We calculated the sensitivity, specificity, positive predictive value, and negative predictive value of detection of gastric focal lesions by MCE, using gastroscopy as the standard.
  
  
  
  MCE detected gastric focal lesions in the whole stomach with 90.4% sensitivity (95% confidence interval [CI], 84.7%-96.1%), 94.7% specificity (95% CI, 91.9%-97.5%), a positive predictive value of 87.9% (95% CI, 81.7%-94.0%), a negative predictive value of 95.9% (95% CI, 93.4%-98.4%), and 93.4% accuracy (95% CI, 90.83%-96.02%). MCE detected focal lesions in the upper stomach (cardia, fundus, and body) with 90.2% sensitivity (95% CI, 82.0%-98.4%) and 96.7% specificity (95% CI, 94.4%-98.9%). MCE detected focal lesions in the lower stomach (angulus, antrum, and pylorus) with 90.6% sensitivity (95% CI, 82.7%-98.4%) and 97.9% specificity (95% CI, 96.1%-99.7%). MCE detected 1 advanced gastric carcinoma, 2 malignant lymphomas, and 1 early stage gastric tumor. MCE did not miss any lesions of significance (including tumors or large ulcers). Among the 350 patients, 5 reported 9 adverse events (1.4%) and 335 preferred MCE over gastroscopy (95.7%).
  
  
  
  MCE detects focal lesions in the upper and lower stomach with comparable accuracy with conventional gastroscopy. MCE is preferred by almost all patients, compared with gastroscopy, and can be used to screen gastric diseases without sedation. Clinicaltrials.gov number: NCT02219529.
authors.affiliation: Department of Gastroenterology, Changhai Hospital, Second Military Medical University, Shanghai, China.
authors.forename: Zhuan
authors.initials: Z
authors.lastname: Liao
authors.affiliation: Department of Gastroenterology, Changhai Hospital, Second Military Medical University, Shanghai, China.
authors.forename: Xi
authors.initials: X
authors.lastname: Hou
authors.affiliation: Department of Gastroenterology, General Hospital of Chinese People's Liberation Army, Beijing, China.
authors.forename: En-Qiang
authors.initials: EQ
authors.lastname: Lin-Hu
authors.affiliation: Department of Gastroenterology, Beijing Military General Hospital, Beijing, China.
authors.forename: Jian-Qiu
authors.initials: JQ
authors.lastname: Sheng
authors.affiliation: Division of Gastroenterology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
authors.forename: Zhi-Zheng
authors.initials: ZZ
authors.lastname: Ge
authors.affiliation: Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
authors.forename: Bo
authors.initials: B
authors.lastname: Jiang
authors.affiliation: Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
authors.forename: Xiao-Hua
authors.initials: XH
authors.lastname: Hou
authors.affiliation: Department of Gastroenterology, Shandong Provincial Hospital, Jinan, China.
authors.forename: Ji-Yong
authors.initials: JY
authors.lastname: Liu
authors.affiliation: Department of Gastroenterology, General Hospital of Chinese People's Liberation Army, Beijing, China.
authors.forename: Zhen
authors.initials: Z
authors.lastname: Li
authors.affiliation: Department of Gastroenterology, General Hospital of Chinese People's Liberation Army, Beijing, China.
authors.forename: Qi-Yang
authors.initials: QY
authors.lastname: Huang
authors.affiliation: Department of Gastroenterology, Beijing Military General Hospital, Beijing, China.
authors.forename: Xiao-Jun
authors.initials: XJ
authors.lastname: Zhao
authors.affiliation: Department of Gastroenterology, Beijing Military General Hospital, Beijing, China.
authors.forename: Na
authors.initials: N
authors.lastname: Li
authors.affiliation: Division of Gastroenterology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
authors.forename: Yun-Jie
authors.initials: YJ
authors.lastname: Gao
authors.affiliation: Division of Gastroenterology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
authors.forename: Yao
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
authors.forename: Jie-Qiong
authors.initials: JQ
authors.lastname: Zhou
authors.affiliation: Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
authors.forename: Xin-Ying
authors.initials: XY
authors.lastname: Wang
authors.affiliation: Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
authors.forename: Jun
authors.initials: J
authors.lastname: Liu
authors.affiliation: Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
authors.forename: Xiao-Ping
authors.initials: XP
authors.lastname: Xie
authors.affiliation: Department of Gastroenterology, Shandong Provincial Hospital, Jinan, China.
authors.forename: Cong-Mei
authors.initials: CM
authors.lastname: Yang
authors.affiliation: Department of Gastroenterology, Shandong Provincial Hospital, Jinan, China.
authors.forename: Hua-Lin
authors.initials: HL
authors.lastname: Liu
authors.affiliation: Department of Gastroenterology, Changhai Hospital, Second Military Medical University, Shanghai, China.
authors.forename: Xiao-Tian
authors.initials: XT
authors.lastname: Sun
authors.affiliation: Department of Gastroenterology, Changhai Hospital, Second Military Medical University, Shanghai, China.
authors.forename: Wen-Bin
authors.initials: WB
authors.lastname: Zou
authors.affiliation: Department of Gastroenterology, Changhai Hospital, Second Military Medical University, Shanghai, China. Electronic address: zhaoshenli@hotmail.com.
authors.forename: Zhao-Shen
authors.initials: ZS
authors.lastname: Li
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000818:Animals; D053704:Capsule Endoscopy / Q000379:methods*; D002681:China; D005260:Female; D005773:Gastroscopy / Q000379:methods*; D006801:Humans; D008280:Magnetics; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D013272:Stomach Diseases / Q000175:diagnosis*; D062606:Tertiary Care Centers; D055815:Young Adult
keywords: Diagnostic Accuracy; Gastric Diseases; Gastroscopy; Magnetically Controlled Capsule Endoscopy; Screening