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Trial registered on ANZCTR


Registration number
ACTRN12618000251224
Ethics application status
Approved
Date submitted
3/02/2018
Date registered
16/02/2018
Date last updated
17/06/2021
Date data sharing statement initially provided
26/02/2019
Date results information initially provided
17/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing levels of pepsin in saliva with 24­-hour probe monitoring in patients clinically diagnosed with Laryngopharyngeal Reflux (LPR)
Scientific title
Comparing Salivary Pepsin Measurement to 24 ­hour Dual Probe Oropharyngeal/Oesophageal pH/Impedance monitoring in patients with a clinical diagnosis of Laryngopharyngeal Reflux: a prospective study
Secondary ID [1] 293930 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Laryngopharyngeal Reflux 306418 0
Condition category
Condition code
Respiratory 305531 305531 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 305532 305532 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patient will be given 5 sputum collection jars with a special reagant. During the same 24 hour period of the 24-hour dual pH/Impedance probe being in situ (after being placed transnasally in clinic), up to 5 of the patient's sputum samples will be collected in these jars.

1st sample - after waking and standing up but before brushing teeth or eating
2nd sample - 60 minutes after lunch
3rd sample - 60 minutes after dinner
+/- 4th/5th sample - immediately after experiencing one of the key symptoms.

* - N.B. - In patients with a diagnosis of laryngopharyngeal reflux, clinicians will elucidate the 3 key symptoms that the patient experiences as a result of their LPR.

Patients will be instructed on how to collect these samples and to keep them refrigerated.
These will also be returned to the clinic where it will be kept refrigerated until analysis by the research team.
Intervention code [1] 300212 0
Diagnosis / Prognosis
Comparator / control treatment
24 ­hour Dual Oropharyngeal/Oesophageal pH/Impedance Probe
Control group
Active

Outcomes
Primary outcome [1] 304659 0
Diagnostic accuracy assessed by determining sensitivity and specificity of two combined tests for laryngopharyngeal reflux (pH/Impedance and Salivary Pepsin assay).

To demonstrate this, we will undertake a statistical analysis. As both are binary diagnostic tests, a paired analysis will be performed. The sensitivity and specificity of the tests will be calculated to determine the diagnostic usefulness. The statisician will also conduct tests of equivalence and non-inferiority via either a differences or ratios method.

The gold standard used to determine sensitivity and specificity will be the 24 hour dual pH/impedance probe.
Timepoint [1] 304659 0
The primary timepoint relative to the patient is 24 hours post probe placement. After 24 hours, the probe will have been removed and the sputum samples will have been collected.
Secondary outcome [1] 342714 0
None
Timepoint [1] 342714 0
None

Eligibility
Key inclusion criteria
50 consenting adult patients (>18 years) presenting to a tertiary ENT/Laryngology Clinic with laryngopharyngeal reflux (LPR)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- People who are unable or unwilling to consent
- People who are unable to complete the pre-intervention questionnaire (Belafsky Reflux Symptom Index (RSI) and Vocal Tract Discomfort Scale).

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will perform paired analysis for binary diagnostic tests.
We calculate Sens and Spec comparing one against the other
We then run a number of tests of equivalence or non-inferiority to ascertain whether the two tests are similar in diagnostic accuracy

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/02/2018
Actual
5/08/2018
Date of last participant enrolment
Anticipated
31/10/2019
Actual
10/02/2020
Date of last data collection
Anticipated
1/11/2019
Actual
17/02/2020
Sample size
Target
50
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9936 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment postcode(s) [1] 18748 0
3165 - East Bentleigh

Funding & Sponsors
Funding source category [1] 298559 0
Hospital
Name [1] 298559 0
Monash Health Department of Surgery
Country [1] 298559 0
Australia
Primary sponsor type
Individual
Name
Debra Phyland
Address
Research Co-ordinator at Monash Health Department of Otolaryngology, Head and Neck Surgery
P.O. Box 72, 867 Rear Centre Road, East Bentleigh Victoria 3165
Country
Australia
Secondary sponsor category [1] 297707 0
None
Name [1] 297707 0
Address [1] 297707 0
Country [1] 297707 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299526 0
Monash Health HREA
Ethics committee address [1] 299526 0
246 Clayton Road, Clayton VIC 3168
Ethics committee country [1] 299526 0
Australia
Date submitted for ethics approval [1] 299526 0
21/12/2017
Approval date [1] 299526 0
20/07/2018
Ethics approval number [1] 299526 0
RES-18-0000-016A

Summary
Brief summary
Aim: To demonstrate the usefulness of two tests for laryngopharyngeal reflux (pH/Impedance and Oral Pepsin ELISA)

Participants: 50 adults (>18 years) with a clinical diagnosis of laryngopharyngeal reflux (LPR) presenting to ENT/laryngology clinic.

Method: Informed consent will be gained from participants, who will be asked to first complete two forms related to their experience of reflux (Belafsky Reflux Symptom Index (RSI)& Vocal Tract Discomfort Scale). Participants will then have a 24­hour dual pH/Impedance probe placed in clinic, confirmed by either manometry (preferred) or direct visualised pullback (DVP) method ­ depending on final departmental budgeting. During this 24 hr period, up to 5 salivary samples will also be collected: 1x upon waking and standing but before breakfast and teeth­brushing, 1x 60minutes after lunch and 1x 60 minutes after dinner. The fourth and fifth samples may be collected following symptoms being experienced by the patient. After 24 hours the probe will be removed and the salivary samples will be returned to the clinic, refrigerated at 4 degrees and analysed within 2 days.

We expect to see increased diagnostic value of combing the results of these two tests.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80726 0
Mr Paul Paddle
Address 80726 0
Consultant Surgeon at Monash Health Department of Otolaryngology, Head and Neck Surgery
P.O. Box 72 Rear 867 Centre Road, East Bentleigh, VIC 3165
Country 80726 0
Australia
Phone 80726 0
+61 447 558 499
Fax 80726 0
Email 80726 0
[email protected]
Contact person for public queries
Name 80727 0
Debra Phyland
Address 80727 0
Research Co-ordinator at Monash Health Department of Otolaryngology, Head and Neck Surgery
P.O. Box 72 Rear 867 Centre Road, East Bentleigh, VIC 3165
Country 80727 0
Australia
Phone 80727 0
+61 409 306 238
Fax 80727 0
Email 80727 0
[email protected]
Contact person for scientific queries
Name 80728 0
Paul Paddle
Address 80728 0
Consultant Surgeon at Monash Health Department of Otolaryngology, Head and Neck Surgery
P.O. Box 72 Rear 867 Centre Road, East Bentleigh, VIC 3165
Country 80728 0
Australia
Phone 80728 0
+61 447 558 499
Fax 80728 0
Email 80728 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Privacy reasons


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes 1. Zhang M, Chia C, Stanley C, Phyland DJ, Paddle ... [More Details]

Documents added automatically
No additional documents have been identified.