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Observational Field Study of Acute Esophageal Food Bolus Impaction by Mean Esophageal Manometry and 24h-pH-monitoring

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. Identifier: NCT01447823
Recruitment Status : Unknown
Verified October 2011 by University of Zurich.
Recruitment status was:  Recruiting
First Posted : October 6, 2011
Last Update Posted : October 12, 2011
Information provided by (Responsible Party):
University of Zurich

Brief Summary:

The aim of this study is to evaluate standard investigations performed in patients with bolus impaction in a prospective observational field study. In bolus impaction, ingested food boluses have to be endoscopically removed. Oesophageal narrowing by scar tissue caused by reflux disease or motility disorders are possible causes of bolus impaction. How common these causes are has up to date never been investigated. The discovery of eosinophilic oesophagitis has broadened differential diagnosis of bolus impaction. Currently high resolution oesophageal manometry and 24-hour pHmetry are performed in addition to endoscopy in the assessment of bolus impaction at the University Hospital Zurich.

The collection of these examination results is the aim of this prospective unrandomised observational field study to assess weather the currently applied procedures are valid to diagnose the cause of impaction to find optimal therapy for each patient.

Condition or disease
Esophageal Motility Disorders

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Field Study of Acute Esophageal Food Bolus Impaction by Mean Esophageal Manometry and 24h-pH-monitoring
Study Start Date : August 2011
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients undergoing upper endoscopy for removal of a food bolus are asked to sign the standard clinical informed consent form for interventional endoscopy of the Division of Gastroenterology at the University Hospital Zurich. After Diagnosis of food impaction has been made, the food bolus has been removed and the endoscopy has been completed, the patient will be informed of the Diagnosis and the standard procedure of care (High resolution manometry, pH-monitoring, blood sampling) will be explained, and an appointment for these procedures will be given (1-4days thereafter).

Inclusion criteria:

  • Patients with acute esophageal bolus impaction coming to the emergency unit of the University Hospital Zurich needing emergency endoscopy for bolus removal
  • Age > 18 years
  • Informed consent

Exclusion criteria:

  • Age under 18 years
  • Inability to understand the informed consent form

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01447823

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Contact: Andreas Steingoetter +41 (0)44 255 5684
Contact: Michael Fried, Professor, MD +41 (0)44 255 2401

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University Hospital Zurich, Gastroenterology and Hepatology Recruiting
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
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Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
Principal Investigator: Michael Fried, Professor, MD University Hospital Zurich, Division of Gastroenterology and Hepatology
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Responsible Party: University of Zurich Identifier: NCT01447823    
Other Study ID Numbers: KEK-ZH Nr 2011-0192
First Posted: October 6, 2011    Key Record Dates
Last Update Posted: October 12, 2011
Last Verified: October 2011
Keywords provided by University of Zurich:
Oesophageal bolus obstruction
Additional relevant MeSH terms:
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Esophageal Motility Disorders
Esophageal Spasm, Diffuse
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases