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14 Wireless pH Testing
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J. Chen and K. A. Perry
Proximal pH Testing
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forLaryngopharyngeal
15
Reux
UmashankkarKannan,
KrzystofM.Nowak, andSubhashKini
Laryngopharyngeal Reux
Laryngopharyngeal reux (LPR) is an inammatory condition of
the upper aerodigestive tract secondary to reux of gastroduodenal contents and characterized by morphologic changes in the
upper aerodigestive tract [1]. There is currently no agreed gold
standard diagnostic criteria. Consequently, many patients may not
be diagnosed with LPR and incidence is therefore underreported.
J.Koufman reported the prevalence of LPR to be 10% in patients
who presented to laryngology clinics and 50% in patients with
voice disorders [2, 3].
The common symptoms of LPR include globus sensation,
hoarseness, sensation of excess throat mucus, dry cough, nonpro-
U. Kannan · S. Kini (*)
Institute for Bariatric and Minimally Invasive Surgery, Mount Sinai
Morningside Medical Center, New York, NY, USA
e-mail: umashankkar.kannan@mountsinai.org;
subhash.kini@mountsinai.org
K. M. Nowak
ENT and Allergy Associates, Yonkers, NY, USA
e-mail: knowak@entandllaergy.com
© Society of American Gastrointestinal and Endoscopic Surgeons
(SAGES) 2023
A. D. Patel et al. (eds.), The SAGES Manual of Physiologic
Evaluation of Foregut Diseases,
https://doi.org/10.1007/978-3-031-39199-6_15
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U. Kannan et al.
ductive throat clearing, dryness or itching of the throat, difculties breathing (especially inspiratory dyspnea), and dysphagia.
Complaints of heartburn and regurgitations are reported inconsistently. Major physical ndings include posterior commissure
hypertrophy, laryngeal/arytenoid erythema and edema, subglottic
edema, and excess endolaryngeal mucus [1]. Laryngopharyngeal
reux is associated with laryngeal granuloma, leukoplakia, laryngeal carcinoma, contact ulcers, vocal nodules, and subglottic stenosis [4]. The abovementioned symptoms and signs are
nonspecic and overlap with other diagnoses such as postnasal
drip due to allergic rhinitis and infection, vocal abuse, effects of
smoking, and alcohol abuse. Further, these ndings are also
noticed in some healthy individuals. Hence, making the diagnosis
of LPR can be very challenging. LPR can also be associated with
nonacid and bile reux. Therapeutic trial of a proton pump inhibitor (PPI) may often not be diagnostic. Hence, performing objective testing to support the clinical diagnosis of LPR is always
necessary.
The objective tests currently in use to make a diagnosis of LPR
include the following:
1. Oropharyngeal pH monitoring.
2. Pepsin detection.
3. Multichannel intraluminal impedance (MII)—pH monitoring.
Presently available diagnostic tests are considered to be suboptimal since their sensitivity and specicity remain uncertain, and
further research is required. Many studies evaluating the diagnostic efcacy of these tests are based on reux symptom index (RSI)
and reux ndings score (RFS) which by themselves are nonspecic and nondiagnostic. The lack of gold standard diagnostic criteria for LPR emphasizes that the interpretation of the results
must be made with caution and in the context of clinical presentation and consideration of overlapping diagnoses.
15 Proximal pH Testing forLaryngopharyngeal Reux
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209
Oropharyngeal pH Monitoring
The Dx-pH measurement system (Restech, Respiratory
Technology Corp, Houston, TX, United States) is a transnasal
device to monitor the oropharyngeal pH [5]. The Restech probe
has a sensor made of antimony that records changes in voltage
potentials relative to pH in the surrounding environment in the
pharynx. The sensor located at the tip of the probe includes reference electrodes and antimony within a 1mm miniature package.
The location of the sensor at the tip rather than side as in traditional probes and the antimony element in the sensor ensures
accuracy by preventing artifacts from dryness of pharynx [6].
The nasal passage is anesthetized with 2% lidocaine, and the
probe is inserted until the light-emitting diode (LED) ashlight is
5–10mm below the uvula (Fig.15.1). The LED light at the tip of
ab
Fig. 15.1 (a) LED light at the tip of the catheter is positioned below the
uvula; (b) transnasal passage of the pH catheter
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U. Kannan et al.
the probe helps in positioning the catheter. The catheter is secured
to the patient’s face, and the transmitter at the end of the catheter
is xed to the patient’s clothing. Patient carries the data recorder
during testing. The pH is measured at the frequency of two times
per second and transmitted to the data recorder.
Patients are requested to keep a diary of symptoms and mealtimes along with the duration of time spent in supine and upright
positions. Patient’s recorded events are then added to the proprietary software (Dataview v4) to calculate data for threshold pH
from 6.5 to 5.
At each pH level (<6.5, <6, <5.5, and <5), the following are
calculated along with other data (Fig.15.2):
• The total %time with pH below baseline.
• The total %time with pH below baseline in upright position.
• The total %time with pH below baseline in supine position.
The values are then plotted in a bar graph in relation to the 75th
and 95th percentile of the normative data in upright and supine
positions at each pH levels (<6.5, <6, <5.5 and <5).
The acid exposure is termed mild, moderate, and severe
depending on the % time exposure at each pH levels (Fig.15.3).
The software also provides the number of episodes of reux and
allows for symptom correlation at each pH level.
The RYAN score was created to identify severe reux patients
with high specicity. A positive RYAN score denotes severe
Fig. 15.2 pH event calculations in upright and supine position and its relation to 75th and 95th percentile of normative data
0RGHUDWH
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Fig. 15.3 Acidic reux graph
211
0LOG
6HYHUH
reux, while a negative score does not rule out mild or moderate
disease.
The RYAN score is calculated based on the following three
values:
1. The number of pH episodes falling below the established
threshold.
2. The duration of the longest episode with pH below the threshold.
3. The total duration of time below the threshold.
A composite score is calculated from the three components.
The score is pathological if the software-generated RYAN score is
>9.41 in upright position (pH 5.5) or >6.81 in supine position
(pH>5.0). If a patient with a positive RYAN score does not show
response to medical treatment, the patient can be considered for
surgical intervention [5].
Pepsin
Pepsin, a proteolytic enzyme secreted in the stomach, is one of the
most deleterious constituents of gastric juice. In addition to being
directly destructive to the laryngeal epithelium, pepsin can also be
endocytosed and activated at low pH inside the cell to cause intracellular injury. Trace amounts of pepsin can be detected in the
saliva of normal individuals, but higher concentrations are seen in
patients with LPR.At this time, there are no clearly established
cutoff values for pepsin assays.
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U. Kannan et al.
Pepsin assays are performed in saliva, sputum samples, or
from laryngeal or pharyngeal biopsies. Biopsy-based assays are
more sensitive than other tests but are much more invasive and
require sedation making them impractical [7].
There are different methods to detect pepsin in saliva like
Peptest (RD Biomed, Hull, UK, distributed as “Pepsincheck” in
USA) or more complex immunohistochemical techniques such as
Western blot or enzyme-linked immunosorbent assay (ELISA).
The techniques based on western blot or ELISA are expensive and
are not available easily. Salivary pepsin assay is a noninvasive,
cost- effective, and convenient way to diagnose LPR and can be
performed on any individual suspected of LPR. Peptest
(Pepsincheck) is an easily available and FDA-approved immunological invitro method to detect the presence of pepsin in saliva at
a concentration equal to or greater than 16 ng/mL [8]. Peptest
(Pepsincheck) requires three samples collected over 24h. It is recommended that the rst sample be obtained upon waking up,
before eating and cleaning teeth. The second and third samples
should be collected after 60min of lunch and dinner, respectively.
If the patient has symptoms during the 24h testing period, the
sample can be collected within 15min of symptoms. The three
samples are mailed for analysis. Proton pump inhibitors or H2
blockers do not interfere with pepsin detection and need not be
held prior to testing. Antacids and alginate suspensions are
stopped for 48h prior to testing. Patients can eat and drink as they
would normally do during 24 h of sample collection. A metaanalysis has shown a pooled sensitivity and specicity of salivary
pepsin in diagnosing LPR to be 64% and 68%, respectively [9].
For diagnosing GERD, salivary pepsin has higher efcacy with
sensitivity and specicity are 73% and 88%. Repeated saliva testing and timing the collection upon waking or after reuxes have
shown to increase the sensitivity of the test. Pepsin testing on
other samples like tracheal aspirates, bronchoalveolar lavage
uid, nasal lavage, and middle ear uid needs further research to
be clinically validated. Further research is still needed to nd the
optimal cutoff value, number of samples, and timing of samples to
diagnose LPR.
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