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

Reflux, Gastroesophageal Clinical Trial

— ENTGI-reflux  

Official title:

Simultaneous Evaluation of Endoscopic Features in Patients Suffering From Gastroesophageal Reflux: Functional Endoscopy Gives Insight for ENT (Ear-nose-throat) and GI Alterations - a Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05634187
• Other study ID #: Endoscopy_ENT-GI-Reflux
• Status: Completed
• Start date: November 20, 2022
• Est. completion date: January 23, 2024

Study information

• Verified date: January 2024
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: January 23, 2024
• Est. primary completion date: January 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Laryngopharyngeal Reflux
• Reflux Disease
• Reflux, Gastroesophageal

Intervention

Device:
• Functional endoscopy
Transnasal endoscopy by an ultrathin video endoscope

Locations

Country	Name	City	State
Germany	University of Muenster	Münster	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Cheung J, Bailey R, Veldhuyzen van Zanten S, McLean R, Fedorak RN, Morse J, Millan M, Guzowski T, Goodman KJ; CANHelp working group. Early experience with unsedated ultrathin 4.9 mm transnasal gastroscopy: a pilot study. Can J Gastroenterol. 2008 Nov;22(1 — View Citation

Herrmann IF, Gadebusch Bondio M, Domagk D, Strahl M, Arens C. [New possibilities with retroflexed functional endoscopy]. HNO. 2018 Jul;66(7):527-533. doi: 10.1007/s00106-018-0518-1. German. — View Citation

Herrmann IF, Scarpignato C. [Functional endoscopy : the physiological and pathophysiological basis of reflux disease, diagnosis and therapy]. HNO. 2009 Dec;57(12):1221-36. doi: 10.1007/s00106-009-1934-z. German. — View Citation

Ruckert J, Lenz P, Heinzow H, Wessling J, Warnecke T, Herrmann IF, Strahl M, Lenze F, Nowacki T, Domagk D. Functional endoscopy in neurogenic dysphagia: a feasibility study focusing on the esophageal phase of swallowing. Endosc Int Open. 2021 Apr;9(4):E64 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endoscopic findings in the laryngeal and pharyngeal area due to reflux	Assessment of endoscopic findings in the laryngeal and pharyngeal area	30 minutes
Primary	Endoscopic findings in the oesophagus due to reflux	Assessment of endoscopic findings in the oesophagus	30 minutes
Secondary	Safety of procedure	Assessments of complications	30 minutes