Clinical Trials Study
Copyright ©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Nov 21, 2016; 22(43): 9595-9603
Published online Nov 21, 2016. doi: 10.3748/wjg.v22.i43.9595
Comparison of multichannel intraluminal impedance-pH monitoring and reflux scintigraphy in pediatric patients with suspected gastroesophageal reflux
Nuray Uslu Kızılkan, Murat Fani Bozkurt, Inci Nur Saltık Temizel, Hülya Demir, Aysel Yüce, Biray Caner, Hasan Özen
Nuray Uslu Kızılkan, Division of Pediatric Gastroenterology, Koc University Hospital, Topkapı, Istanbul 34010, Turkey
Murat Fani Bozkurt, Biray Caner, Hacettepe University Faculty of Medicine, Department of Nuclear Medicine, Ankara 06100, Turkey
Inci Nur Saltık Temizel, Hülya Demir, Aysel Yüce, Hasan Özen, Division of Gastroenterology, Hepatology and Nutrition Unit, Department of Pediatrics, Hacettepe University Faculty of Medicine, Ankara 06100, Turkey
Author contributions: Uslu Kızılkan N acquired the data, conducted the pH and impedance studies, contributed to the data analysis, and drafted the manuscript; Bozkurt MF and Caner B conducted the scintigraphic studies and analysis; Saltık Temizel IN, Demir H and Yüce A acquired the data; Özen H conceived and designed the project, conducted the pH and impedance studies, analyzed the data, and edited the manuscript.
Supported by the Scientific and Technological Research Council of Turkey, No. 106S191- SBAG-3439.
Institutional review board statement: This clinical study was reviewed and approved by Hacettepe University Clinical Researches Ethics Board (03.03.2006; B.30.2.HAC.0.01.00.05/222).
Clinical trial registration statement: This registration policy applies to prospective, randomized, controlled trials only.
Informed consent statement: Informed written consent was acquired from all participants or their legal guardian prior to study enrollment.
Conflict-of-interest statement: There are no potential conflicts of interest for any of the authors.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Hasan Özen, MD, Division of Gastroenterology, Hepatology and Nutrition Unit, Department of Pediatrics, Hacettepe University Faculty of Medicine, Hacettepe, Ankara 06100, Turkey. haozen@hacettepe.edu.tr
Telephone: +90-312-3051993 Fax: +90-312-3118226
Received: August 12, 2016
Peer-review started: August 19, 2016
First decision: September 14, 2016
Revised: September 27, 2016
Accepted: October 19, 2016
Article in press: October 19, 2016
Published online: November 21, 2016
Processing time: 97 Days and 16.3 Hours
Abstract
AIM

To evaluate the agreement of multichannel intraluminal impedance-pH monitoring (MII-pHM) and gastroesophageal reflux scintigraphy (GES) for the diagnosis of gastroesophageal reflux disease.

METHODS

Seventy-five consecutive patients with suspected gastroesophageal reflux disease (GERD) underwent 24-h combined MII-pHM recording and one hour radionuclide scintigraphy during the course of the MII-pHM study. Catheters with 6 impedance channels and 1 pH sensor were placed transnasally. Impedance and pH data analysis were performed automatically and manually. For impedance monitoring, reflux was defined as a retrograde 50% drop in impedance, starting distally and propagating retrogradely to at least the next two more proximal measuring channels. Reflux index (RI, percentage of the entire record that esophageal pH is < 4.0) greater than 4.2% for pHM and number of refluxes more than 50 for 24 h for MII were accepted as positive test results. At scintigraphy, 240 frames of 15 seconds duration were acquired in the supine position. Gastroesophageal reflux was defined as at least one reflux episode in the esophagus. After scintigraphic evaluation, impedance-pH recordings and scintigraphic images were evaluated together and agreement between tests were evaluated with Cohen’s kappa.

RESULTS

Sufficient data was obtained from 60 (80%) patients (34 male, 56.7%) with a mean age of 8.7 ± 3.7 years (range: 2.5-17.3 years; median: 8.5 years). Chronic cough, nausea, regurgitation and vomiting were the most frequent symptoms. The mean time for recording of MII-pHM was 22.8 ± 2.4 h (range: 16-30 h; median: 22.7 h). At least one test was positive in 57 (95%) patients. According to diagnostic criteria, GERD was diagnosed in 34 (57.7%), 44 (73.3%), 47 (78.3%) and 51 (85%) patients by means of pHM, MII, GES and MII-pHM, respectively. The observed percentage agreements/κ values for GES and pHM, GES and MII, GES and MII-pHM, and MII and pHM are 48.3%/-0.118; 61.7%/-0.042; 73.3%/0.116 and 60%/0.147, respectively. There was no or slight agreement between GES and pHM alone, MII alone or MII-pHM. pH monitoring alone missed 17 patients compared to combined MII-pHM. The addition of MII to pH monitoring increased the diagnosis rate by 50%.

CONCLUSION

No or slight agreement was found among pH monitoring, MII monitoring, MII-pH monitoring and GES for the diagnosis of gastroesophageal reflux disease.

Keywords: Gastroesophageal reflux disease; Children; Multichannel intraluminal impedance; Esophageal pH monitoring; Scintigraphy

Core tip: Gastroesophageal reflux (GER) is usually physiological, common in childhood and defined as GER disease (GERD) when it causes troublesome symptoms and/or complications. Unfortunately, the ideal diagnostic method for GERD has not been identified yet. Each method has its own advantages and disadvantages. This study aimed to evaluate the agreement of multichannel intraluminal impedance-pH monitoring and gastroesophageal reflux scintigraphy, which is used frequently all over the world for the diagnosis of GERD. No or slight agreement between tests was found. New diagnostic standards for scintigraphy in GERD should be defined.