Observational Field Study of Acute Esophageal Food Bolus Impaction by Mean Esophageal Manometry and 24h-pH-monitoring
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Purpose
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.
| Study Type: | Observational |
| Study Design: | 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 |
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
Contacts and Locations| Contact: Andreas Steingoetter | +41 (0)44 255 5684 | andreas.steingoetter@usz.ch |
| Contact: Michael Fried, Professor, MD | +41 (0)44 255 2401 | michael.fried@usz.ch |
| Switzerland | |
| University Hospital Zurich, Gastroenterology and Hepatology | Recruiting |
| Zurich, Switzerland | |
| Study Director: | 01 Studienregister MasterAdmins | UniversitaetsSpital Zuerich |
| Principal Investigator: | Michael Fried, Professor, MD | University Hospital Zurich, Division of Gastroenterology and Hepatology |
More Information
No publications provided
| Responsible Party: | University of Zurich |
| ClinicalTrials.gov Identifier: | NCT01447823 History of Changes |
| Other Study ID Numbers: | KEK-ZH Nr 2011-0192 |
| Study First Received: | September 27, 2011 |
| Last Updated: | October 7, 2011 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by University of Zurich:
|
Oesophageal bolus obstruction Gastroscopy phmetry |
Additional relevant MeSH terms:
|
Esophageal Diseases Esophageal Motility Disorders Esophageal Spasm, Diffuse |
Gastrointestinal Diseases Digestive System Diseases Deglutition Disorders |
ClinicalTrials.gov processed this record on June 18, 2013