Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Functional Endoscopy in Neurogenic Dysphagia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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):
Dr. Dirk Domagk, University Hospital Muenster

Tracking Information
First Submitted Date November 18, 2013
First Posted Date November 27, 2013
Last Update Posted Date November 27, 2013
Study Start Date September 2012
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 21, 2013)
Number of patients in which the procedure may be successfully performed (feasibility) [ Time Frame: 30 minutes ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: November 21, 2013)
  • Pathologic endoscopic findings in patients suffering from neurogenic dysphagia [ Time Frame: 30 minutes ]
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Functional Endoscopy in Neurogenic Dysphagia
Official Title Transnasal Endoscopic Evaluation of Swallowing: Functional Esophagoscopy Using an Ultrathin Video Endoscope in Neurogenic Dysphagia
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).

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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The focus of our observational study are patients with suspected neurogenic dysphagia.
Condition Neurogenic Dysphagia
Intervention Procedure: transnasal functional endoscopy
Other Name: ultrathin video endoscope with an outer diameter of 3.8 mm (BF-3C160, Olympus Europe)
Study Groups/Cohorts neurogenic dysphagia
Patients suffering from neurogenic dysphagia due to several reasons (e.g. Parkinson´s disease).
Intervention: Procedure: transnasal functional endoscopy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 21, 2013)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2014
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01995929
Other Study ID Numbers 2012_2013_003
TNE_2010 ( Other Identifier: University Hospital of Muenster )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Dirk Domagk, University Hospital Muenster
Study Sponsor University Hospital Muenster
Collaborators Not Provided
Investigators Not Provided
PRS Account University Hospital Muenster
Verification Date November 2013