Functional Endoscopy in Neurogenic Dysphagia

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University Hospital Muenster
Sponsor:
Information provided by (Responsible Party):
Dr. Dirk Domagk, University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT01995929
First received: November 18, 2013
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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 Intervention
Neurogenic Dysphagia
Procedure: transnasal functional endoscopy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Transnasal Endoscopic Evaluation of Swallowing: Functional Esophagoscopy Using an Ultrathin Video Endoscope in Neurogenic Dysphagia

Resource links provided by NLM:


Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • Number of patients in which the procedure may be successfully performed (feasibility) [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pathologic endoscopic findings in patients suffering from neurogenic dysphagia [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    safety of transnasal functional endoscopy in diagnostics of neurogenic dysphagia


Estimated Enrollment: 50
Study Start Date: September 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: November 18, 2013
Last Updated: November 21, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Muenster:
neurogenic dysphagia
transnasal endoscopy
functional endoscopy

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

ClinicalTrials.gov processed this record on October 29, 2014