One-stop-shop Endoscopy in Reflux-patients: Evaluation of ENT and GI Features

Completed

• Conditions: Reflux Disease; Reflux, Gastroesophageal; Reflux, Laryngopharyngeal
• Interventions: Device: Functional endoscopy

• Registration Number: NCT05634187
• Lead Sponsor: University Hospital Muenster

Brief Summary

Patients suffering from gastroesophageal reflux may suffer from both esophageal and laryngeal irritations. The investigators developed an endoscopic technique called functional endoscopy to evaluate alterations in the larynx and pharynx as well as in the esophagus simultaneously as one-stop-shop.

Detailed Description

Patients suffering from gastroesophageal reflux may present to a variety of medical specialists according to their individual complaints (e.g., heartburn, hoarseness, dysphasia). In general, these addressed specialist may focus their attention to their individual fields of interest.

The investigators developed an endoscopic technique called functional endoscopy to evaluate patients with various GI- or ENT (ear-nose-throat)-symptoms being suggestive for gastroesophageal reflux disease.

In functional endoscopy, unsedated patients are examined with an ultrathin endoscope via the transnasal route. Reflux-associated features in the field of interest of the ENT-doctor and the GI-specialist are recorded and documented in the same session.

Study Timeline

• Study Start: 2022-11-20
• Study First Submitted: 2022-11-21
• Study First Submitted QC: 2022-11-30
• Study First Posted: 2022-12-02
• Status Verified: 2024-01
• Primary Completion: 2024-01-23
• Study Completion: 2024-01-23
• Last Update Submitted: 2024-04-12
• Last Update Posted: 2024-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

• Patients suffering from dysphasia, heartburn, laryngitis or pharyngitis suggestive for gastroesophageal reflux disease

Exclusion Criteria

• Age under 18 years
• Inability to understand information for participation
• Refusal of participation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients suffering from symptoms suggestive for gastroesophageal reflux disease	Functional endoscopy	Patients suffering from dysphasia, heartburn, laryngitis or pharyngitis suggestive for gastroesophageal reflux disease

Primary Outcome Measures

Name	Time	Method
Endoscopic findings in the laryngeal and pharyngeal area due to reflux	30 minutes	Assessment of endoscopic findings in the laryngeal and pharyngeal area
Endoscopic findings in the oesophagus due to reflux	30 minutes	Assessment of endoscopic findings in the oesophagus

Secondary Outcome Measures

Name	Time	Method
Safety of procedure	30 minutes	Assessments of complications

Trial Locations

Locations (1)

University of Muenster; 🇩🇪 Münster, NRW, Germany