Original Article
Copyright ©2014 Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Oct 28, 2014; 20(40): 14865-14874
Published online Oct 28, 2014. doi: 10.3748/wjg.v20.i40.14865
Wireless esophageal pH capsule for patients with gastroesophageal reflux disease: A multicenter clinical study
Xiao-Jun Yang, Tian Gan, Lei Wang, Zhuan Liao, Xiao-Hong Tao, Wei Shen, Xiao-Yan Zhao
Xiao-Jun Yang, Tian Gan, Lei Wang, Xiao-Yan Zhao, Department of Gastroenterology, Xinqiao Hospital, Third Military Medical University, Chongqing 400037, China
Zhuan Liao, Department of Gastroenterology, Changhai Hospital, Second Military Medical University, Shanghai 200433, China
Xiao-Hong Tao, Department of Gastroenterology, First Affiliated Hospital of Chongqing Medical University, Chongqing 400016, China
Wei Shen, Department of Gastroenterology, Second Affiliated Hospital of Chongqing Medical University, Chongqing 400010, China
Author contributions: Yang XJ and Gan T wrote the paper and contributed equally to this study; Yang X, Gan T, Wang L, Liao Z, Tao XH, Shen W and Zhao XY performed the research; Yang XJ and Gan T analyzed the data; and Zhao XY designed this research.
Supported by Grants from the Innovation Fund for Technology-Based Firms of the Ministry of Science and Technology of the China, No. 12C26215115999 (in part); Special Fund on Industrial Revitalization and Transformation of the National Development and Reform Commission of the China; and Jinshan Science and Technology Co. Ltd, Chongqing, China
Correspondence to: Xiao-Yan Zhao, Professor, Department of Gastroenterology, Xinqiao Hospital, Third Military Medical University, No. 30 Gaotanyan Street, Shapingba District, Chongqing 400037, China. zhaoxx@medmail.com.cn
Telephone: +86-23-67063969 Fax: +86-23-68774604
Received: December 26, 2013
Revised: May 5, 2014
Accepted: July 22, 2014
Published online: October 28, 2014
Processing time: 370 Days and 19.5 Hours
Abstract

AIM: To investigate the feasibility and safety of pH capsule to monitor pH in patients with gastroesophageal reflux disease (GERD).

METHODS: Ninety-one patients with symptoms suggestive of GERD were enrolled in this study, 46 of whom were randomized to the pH capsule group; the remaining 45 patients used the conventional catheter and pH capsule simultaneously. The pH data and traces were recorded via automatic analysis, and capsule detachment was assessed using X-ray images. All of the patients were required to complete a questionnaire regarding tolerance with the capsule.

RESULTS: The capsules were successfully attached on the first attempt, and no early detachment of the capsules was observed. Compared to the 24-h pH data recorded with the conventional catheter, the data collected with the pH capsule showed no significant differences in 24-h esophageal acid exposure. The measurements of esophageal acid exposure over 24 h collected with the two devices showed a significant correlation (r2 = 0.996, P < 0.001). Capsule detachment occurred spontaneously in 89 patients, and 2 capsules required endoscopic removal due to chest pain. The capsule was associated with less interference with daily activity.

CONCLUSION: The wireless pH capsule provides a feasible and safe method for monitoring gastroesophageal reflux and therefore may serve as an important tool for diagnosing GERD.

Keywords: Wireless pH capsule; Feasibility; Safety; Conventional catheter; Gastroesophageal reflux disease

Core tip: The new pH capsule (JSPH-1, made by Jinshan Science and Technology Co. Ltd, Chongqing, China), a wireless pH capsule developed in China, was introduced as an alternative method for pH monitoring. Compared with the result recorded synchronously with MMS catheter, that obtained with JSPH-1 pH capsule was of uniformity. Our study suggested that JSPH-1 pH capsule is feasible, safe, well tolerated for monitoring reflux in patients with gastroesophageal reflux disease (GERD), therefore it may serve as an important tool for the diagnosis of GERD.