Functional Endoscopy in Neurogenic Dysphagia

NCT01995929 | Completed

• 2 other identifiers: 2012_2013_003TNE_2010
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 2

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).

Conditions

Neurogenic Dysphagia

Keywords

neurogenic dysphagia; transnasal endoscopy; functional endoscopy

Outcome Measures

Primary Outcomes (1)

• Number of patients in which the procedure may be successfully performed (feasibility)

  Feasibility, safety, and tolerability of the procedure

  30 minutes

Secondary Outcomes (2)

• Pathologic endoscopic findings in patients suffering from neurogenic dysphagia

  30 minutes

• Number of patients with adverse events as a measure of safety and tolerability

  1 week

Study Arms (1)

neurogenic dysphagia

Patients suffering from neurogenic dysphagia due to several reasons (e.g. Parkinson´s disease).

Procedure: transnasal functional endoscopy

Interventions

transnasal functional endoscopy PROCEDURE

Also known as: ultrathin video endoscope with an outer diameter of 3.8 mm (BF-3C160, Olympus Europe)

neurogenic dysphagia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The focus of our observational study are patients with suspected neurogenic dysphagia.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (2)

Josephs Hospital Warendorf

Warendorf, North Rhine-Westphalia, 48231, Germany

Location

University Hospital of Muenster

Münster, Germany

Location

Related Publications (8)

• 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.

  PMID: 19018337 BACKGROUND

• 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.

  PMID: 19319127 BACKGROUND

• 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.

  PMID: 19329697 BACKGROUND

• Warnecke T, Teismann I, Oelenberg S, Hamacher C, Ringelstein EB, Schabitz 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.

  PMID: 19284543 BACKGROUND

• Warnecke T, Teismann I, Oelenberg S, Hamacher C, Ringelstein EB, Schabitz 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.

  PMID: 19074481 BACKGROUND

• 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.

  PMID: 18217186 BACKGROUND

• 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.

  PMID: 19924362 BACKGROUND

• 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.

  PMID: 33880400 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Dirk Domagk

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: November 27, 2013
• Study Start: December 1, 2013
• Primary Completion: October 31, 2017
• Study Completion: October 31, 2017
• Last Updated: November 9, 2022

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)