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Functional Endoscopy in Neurogenic Dysphagia

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ClinicalTrials.gov Identifier: NCT01995929
Recruitment Status : Unknown
Verified November 2013 by Dr. Dirk Domagk, University Hospital Muenster.
Recruitment status was:  Recruiting
First Posted : November 27, 2013
Last Update Posted : November 27, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The esophago-gastro-duodenoscopy is an endoscopic examination technique of the upper GI-tract which was founded by the German surgeon Johann Freiherr von Mikuliicz-Radecki at the end of 19th century. By this means, the luminal site of the esophagus, stomach and duodenum may be visualized after inserting a flexible endoscope through the mouth (transoral access). By the rapid technical development in the last years smaller flexible video endoscopes have been developed allowing also an alternative access to the upper GI-tract via the nose (transnasal access).

Patients with dysphagia are referred to physicians of different disciplines (gastroenterology, surgery, ear, nose, and throat (ENT) medicine, radiology, neurology) performing a variety of endoscopic and non-endoscopic techniques. Mostly, the endoscopic examination of the esophagus is done in sedated patients in left lateral examination. Typical findings during esophagoscopy might be tumors, strictures, achalasia or diverticula.

Patients suffering from neurogenic dysphagia often get caught in the trap: they find themselves somewhere in the space between gastroenterologist, neurologist, ENT-specialist and radiologist. This dilemma might be due to a lack of pathophysiological knowledge among many physicians and an inability to directly visualize the esophageal phase of deglutition. In sedated patients lying in left lateral position, endoscopists may receive a very limited impression of the function of the different phases of swallowing since this endoscopic access is a rather static one.

The focus of our observational study are patients with suspected neurogenic dysphagia. These patients shall be examined by transnasal endoscopy applying an ultrathin video endoscope with an outer diameter of 3.8 mm (BF-3C160, Olympus Europe). Patients are examined in sitting position while ingesting water and food of different consistencies (functional endoscopy). Diagnostic shall be completed and correlated by videofluoroscopy, high-resolution manometry and assessment of the clinical signs. Beside feasibility and safety as primary endpoints, secondary endpoints shall be the assessment of pathologic endoscopic findings in patients suffering from neurogenic dysphagia. The study is approved by the local Ethics Committee (AZ 2010-214-f-S).


Condition or disease Intervention/treatment
Neurogenic Dysphagia Procedure: transnasal functional endoscopy

Detailed Description:

The esophago-gastro-duodenoscopy is an endoscopic examination technique of the upper GI-tract which was founded by the German surgeon Johann Freiherr von Mikuliicz-Radecki at the end of 19th century. By this means, the luminal site of the esophagus, stomach and duodenum may be visualized after inserting a flexible endoscope through the mouth (transoral access). By the rapid technical development in the last years smaller flexible video endoscopes have been developed allowing also an alternative access to the upper GI-tract via the nose (transnasal access).

Patients with dysphagia are referred to physicians of different disciplines (gastroenterology, surgery, ear, nose, and throat (ENT) medicine, radiology, neurology) performing a variety of endoscopic and non-endoscopic techniques. Mostly, the endoscopic examination of the esophagus is done in sedated patients in left lateral examination. Typical findings during esophagoscopy might be tumors, strictures, achalasia or diverticula. In sedated patients lying in left lateral position, endoscopists may, therefore, receive a very limited impression of the actual function of the different phases of swallowing since this endoscopic approach is a rather static one.

Patients suffering from neurogenic dysphagia often get caught in the trap: they find themselves somewhere in the space between gastroenterologist, neurologist, ENT-specialist and radiologist. This dilemma might be due to a lack of pathophysiological knowledge among many physicians and an inability to directly visualize the esophageal phase of deglutition.

The focus of our observational study are patients with suspected neurogenic dysphagia. These patients shall be examined by transnasal endoscopy applying an ultrathin video endoscope with an outer diameter of 3.8 mm (BF-3C160, Olympus Europe). Patients are examined in sitting position while ingesting water and food of different consistencies (functional endoscopy). Diagnostic shall be completed and correlated by videofluoroscopy, high-resolution manometry and assessment of the clinical signs. Beside feasibility and safety as primary endpoints, secondary endpoints shall be the assessment of pathologic endoscopic findings in patients suffering from neurogenic dysphagia. The study is approved by the local Ethics Committee (AZ 2010-214-f-S).


Study Design

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Transnasal Endoscopic Evaluation of Swallowing: Functional Esophagoscopy Using an Ultrathin Video Endoscope in Neurogenic Dysphagia
Study Start Date : September 2012
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
neurogenic dysphagia
Patients suffering from neurogenic dysphagia due to several reasons (e.g. Parkinson´s disease).
Procedure: transnasal functional endoscopy
Other Name: ultrathin video endoscope with an outer diameter of 3.8 mm (BF-3C160, Olympus Europe)


Outcome Measures

Primary Outcome Measures :
  1. Number of patients in which the procedure may be successfully performed (feasibility) [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  1. Pathologic endoscopic findings in patients suffering from neurogenic dysphagia [ Time Frame: 30 minutes ]
  2. Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 1 week ]
    safety of transnasal functional endoscopy in diagnostics of neurogenic dysphagia


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The focus of our observational study are patients with suspected neurogenic dysphagia.
Criteria

Inclusion Criteria:

  • patients with suspected neurogenic dysphagia, not fulfilling the exclusion criteria

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995929


Contacts
Contact: Dirk Domagk, M.D. 00492518347559 domagkd@uni-muenster.de
Contact: Philipp Lenz, M.D. 00492518349509 lenzph@uni-muenster.de

Locations
Germany
University Hospital of Muenster Recruiting
Muenster, Germany
Principal Investigator: Dirk Domagk, M.D.         
Sponsors and Collaborators
University Hospital Muenster
More Information

Publications:

Responsible Party: Dr. Dirk Domagk, Prof. Dr. med. Dirk Domagk, University Hospital Muenster
ClinicalTrials.gov Identifier: NCT01995929     History of Changes
Other Study ID Numbers: 2012_2013_003
TNE_2010 ( Other Identifier: University Hospital of Muenster )
First Posted: November 27, 2013    Key Record Dates
Last Update Posted: November 27, 2013
Last Verified: November 2013

Keywords provided by Dr. Dirk Domagk, University Hospital Muenster:
neurogenic dysphagia
transnasal endoscopy
functional endoscopy

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases