Functional Endoscopy in Neurogenic Dysphagia

Neurogenic Dysphagia Clinical Trial

Official title:

Transnasal Endoscopic Evaluation of Swallowing: Functional Esophagoscopy Using an Ultrathin Video Endoscope in Neurogenic Dysphagia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01995929
• Other study ID #: 2012_2013_003
• Secondary ID: TNE_2010
• Status: Completed
• Start date: December 2013
• Est. completion date: October 31, 2017

Study information

• Verified date: December 2020
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Neurogenic Dysphagia

Intervention

Procedure:
• transnasal functional endoscopy

Locations

Country	Name	City	State
Germany	University Hospital of Muenster	Muenster
Germany	Josephs Hospital Warendorf	Warendorf	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

References & Publications (7)

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. — 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. Review. German. — View Citation

Warnecke T, Teismann I, Oelenberg S, Hamacher C, Ringelstein EB, Schäbitz WR, Dziewas R. The safety of fiberoptic endoscopic evaluation of swallowing in acute stroke patients. Stroke. 2009 Feb;40(2):482-6. doi: 10.1161/STROKEAHA.108.520775. Epub 2008 Dec 12. — View Citation

Warnecke T, Teismann I, Oelenberg S, Hamacher C, Ringelstein EB, Schäbitz WR, Dziewas R. Towards a basic endoscopic evaluation of swallowing in acute stroke - identification of salient findings by the inexperienced examiner. BMC Med Educ. 2009 Mar 10;9:13. doi: 10.1186/1472-6920-9-13. — View Citation

Warnecke T, Teismann I, Zimmermann J, Oelenberg S, Ringelstein EB, Dziewas R. Fiberoptic endoscopic evaluation of swallowing with simultaneous Tensilon application in diagnosis and therapy of myasthenia gravis. J Neurol. 2008 Feb;255(2):224-30. doi: 10.1007/s00415-008-0664-6. Epub 2008 Jan 28. — View Citation

Wiegand N, Bauerfeind P, Delco F, Fried M, Wildi SM. Endoscopic position control of nasoenteral feeding tubes by transnasal re-endoscopy: a prospective study in intensive care patients. Am J Gastroenterol. 2009 May;104(5):1271-6. doi: 10.1038/ajg.2009.26. Epub 2009 Mar 24. — View Citation

Zhihui T, Wenkui Y, Weiqin L, Zhiming W, Xianghong Y, Ning L, Jieshou L. A randomised clinical trial of transnasal endoscopy versus fluoroscopy for the placement of nasojejunal feeding tubes in patients with severe acute pancreatitis. Postgrad Med J. 2009 Feb;85(1000):59-63. doi: 10.1136/pgmj.2008.070326. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients in which the procedure may be successfully performed (feasibility)	Feasibility, safety, and tolerability of the procedure	30 minutes
Secondary	Pathologic endoscopic findings in patients suffering from neurogenic dysphagia	Acquisition of pathologenic mechanism during swallowing	30 minutes
Secondary	Number of patients with adverse events as a measure of safety and tolerability	safety of transnasal functional endoscopy in diagnostics of neurogenic dysphagia	1 week