Comprehensive Analysis of the Swallowing Mechanism Using High-resolution Manometry With Impedance

University Hospital Ostrava

Status: Not yet enrolling

Conditions: Dysphagia; Laryngopharyngeal Reflux; Extraesophageal Reflux; Chronic Cough

Treatments: Diagnostic Test: 24-hour pH metry; Diagnostic Test: High resolution oesophageal manometry with impedance

Study type: Interventional

Funder types: Other

Identifiers

NCT07365046

FNO-ENT-Manometry

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Extraoesophageal reflux

Experimental group

Description:

Patients with extraoesophageal reflux will be enrolled in this study arm.

Treatment:

Diagnostic Test: 24-hour pH metry

Diagnostic Test: High resolution oesophageal manometry with impedance

Dysphagia

Experimental group

Description:

Patients with dysphagia reflux will be enrolled in this study arm.

Treatment:

Diagnostic Test: High resolution oesophageal manometry with impedance