Comprehensive Analysis of the Swallowing Mechanism Using High-resolution Manometry With Impedance
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High resolution oesophageal manometry with impedance, 24-hour pH metry.
- Who it may be relevant to
- Registry conditions: Extraesophageal Reflux, Laryngopharyngeal Reflux, Dysphagia, Chronic Cough. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The aim of this project is to perform a detailed evaluation of upper esophageal sphincter function and the swallowing mechanism in patients with swallowing disorders or suspected extraesophageal reflux using high-resolution manometry with impedance and 24-hour pH-impedance monitoring.
Detailed description
The project seeks to improve diagnostic accuracy, identify functional abnormalities that are not detectable by conventional diagnostic methods, and establish a foundation for more effective and targeted therapeutic strategies.
The upper esophageal sphincter (UES) represents a crucial functional structure at the junction of the digestive and respiratory tracts. Its proper function is essential for the coordination of the swallowing process and for the protection of the upper airways. Disorders of the UES may be associated with a wide range of otorhinolaryngological symptoms, including dysphagia, globus pharyngeus, chronic cough, hoarseness, laryngeal dysfunction, and voice disorders. Modern diagnostic techniques, such as 24-hour esophageal impedance monitoring and high-resolution manometry (HRM), enable detailed assessment of gastroesophageal reflux and esophageal pressure dynamics, thereby offering new possibilities for the diagnosis and understanding of these conditions.
Interventions
- Diagnostic test High resolution oesophageal manometry with impedance
Patients with extraoesophageal reflux and dysphagia will undergo high resolution oesophageal manometry with impedance. - Diagnostic test 24-hour pH metry
Patients with extraoesophageal reflux will undergo 24-hour pH-metry.
Primary outcome measures
- PAET (Proximal Acid Exposure Time) [Time frame: 24 hours]
- Upper esophageal sphincter (UES) Integrated Relaxation Pressure (IRP) [Time frame: 15 minutes]
- UES Maximum Admittance [Time frame: 15 minutes]
Eligibility criteria
Inclusion criteria
- age 18-75 years
- patients with swallowing difficulties suspected of having a functional oesophageal disorder or patients with clinical signs of extra-oesophageal reflux (Reflux Symptom Index \[RSI\] ≥ 13 or Reflux Symptom Score-12 \[RSS-12\] ≥ 11) signed informed consent
Exclusion criteria
- patients with a diagnosed tumor of the esophagus or upper airway, or with strong clinical suspicion of a tumor of the esophagus or upper airway
- severe neurological disease affecting swallowing
- pregnancy
- surgery involving the head, neck, or esophagus within the last 6 months
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Czechia · 1 center
- University Hospital Ostrava — Ostrava
Publications
- Omari TI, Maclean JCF, Cock C, McCulloch TM, Nativ-Zeltzer N, O'Rourke AK, Szczesniak MM, Wu PI, Allen J, Aoyagi Y, Bayona HHG, Carrion S, Ciucci MR, Davidson K, Dhar SI, Hamdy S, Howell R, Jones C, Knigge MA, Moonen A, Postma GN, Puntil-Sheltman J, Rameau A, Regan J, Schar M, Rommel N. Defining Pharyngeal and Upper Esophageal Sphincter Disorders on High-Resolution Manometry-Impedance: The Leuven PMID 40202098
- Omari T, Cock C, Wu P, Szczesniak MM, Schar M, Tack J, Rommel N. Using high resolution manometry impedance to diagnose upper esophageal sphincter and pharyngeal motor disorders. Neurogastroenterol Motil. 2023 Jan;35(1):e14461. doi: 10.1111/nmo.14461. Epub 2022 Sep 19. PMID 36121685
- Wang YC, Wang CC, Chuang CY, Tsou YA, Peng YC, Chang CS, Lien HC. Baseline Impedance via Manometry Predicts Pathological Mean Nocturnal Baseline Impedance in Isolated Laryngopharyngeal Reflux Symptoms. J Neurogastroenterol Motil. 2025 Jan 31;31(1):63-74. doi: 10.5056/jnm24051. PMID 39779205
- Watson W, Simmons E, Adebowale A, Banda C, Qu R, Becerra B, Crawley B, Murry T, Krishna P. Manometric Abnormalities in Patients With and Without Chronic Cough. Am J Otolaryngol. 2024 Nov-Dec;45(6):104445. doi: 10.1016/j.amjoto.2024.104445. Epub 2024 Jul 31. PMID 39102762
- Tseng WH, Hsu WC, Hsiao TY, Wu JF, Lee HC, Wang HP, Wu MS, Tseng PH. Anatomical and physiological characteristics in patients with Laryngopharyngeal Reflux Symptoms: A case-control study utilizing high-resolution impedance manometry. J Formos Med Assoc. 2022 Jun;121(6):1034-1043. doi: 10.1016/j.jfma.2021.07.025. Epub 2021 Aug 6. PMID 34366184
Identifiers
NCT: NCT07365046 · FNO-ENT-Manometry