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

NCT ID: NCT05634187

Last Updated: 2024-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

190 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-20

Study Completion Date

2024-01-23

Brief Summary

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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

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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.

Conditions

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Reflux Disease Reflux, Gastroesophageal Reflux, Laryngopharyngeal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients suffering from symptoms suggestive for gastroesophageal reflux disease

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

Functional endoscopy

Intervention Type DEVICE

Transnasal endoscopy by an ultrathin video endoscope

Interventions

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Functional endoscopy

Transnasal endoscopy by an ultrathin video endoscope

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Muenster

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dirk Domagk, MD

Role: STUDY_CHAIR

Josephs Hospital Warendorf, Academic Teaching Hospital University of Muenster

Locations

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University of Muenster

Münster, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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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(11):917-22. doi: 10.1155/2008/323027.

Reference Type RESULT
PMID: 19018337 (View on PubMed)

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.

Reference Type RESULT
PMID: 19924362 (View on PubMed)

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.

Reference Type RESULT
PMID: 29968191 (View on PubMed)

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):E646-E652. doi: 10.1055/a-1380-3224. Epub 2021 Apr 15.

Reference Type RESULT
PMID: 33880400 (View on PubMed)

Other Identifiers

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Endoscopy_ENT-GI-Reflux

Identifier Type: -

Identifier Source: org_study_id

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