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Completed

NCT Number: NCT01995929

Functional Endoscopy in Neurogenic Dysphagia

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Josephs Hospital Warendorf, Warendorf, North Rhine-Westphalia, Germany

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transnasal functional endoscopy

Procedure

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

Primary outcomes

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

    Time frame: 30 minutes

    Feasibility, safety, and tolerability of the procedure

Secondary outcomes

  1. Pathologic endoscopic findings in patients suffering from neurogenic dysphagia

    Time frame: 30 minutes

    Acquisition of pathologenic mechanism during swallowing

  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

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Nov 27, 2013
Registry last updated
Nov 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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