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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by University of Zurich.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01447823
First received: September 27, 2011
Last updated: October 7, 2011
Last verified: October 2011
  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.


Condition Phase
Esophageal Motility Disorders
Phase 1

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

Further study details as provided by University of Zurich:

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
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).

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447823

Contacts
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

Locations
Switzerland
University Hospital Zurich, Gastroenterology and Hepatology Recruiting
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
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 Motility Disorders
Esophageal Spasm, Diffuse
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on November 25, 2014