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

NCT01447823 | Unknown DMC

• 1 other identifier: KEK-ZH Nr 2011-0192
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Motility Disorders

Keywords

Oesophageal bolus obstruction; Gastroscopy; phmetry

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Gastroenterology and Hepatology

Zurich, Switzerland

RECRUITING

MeSH Terms

Conditions

Esophageal Motility Disorders

Condition Hierarchy (Ancestors)

Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• 01 Studienregister MasterAdmins

  UniversitaetsSpital Zuerich

  STUDY DIRECTOR

• Michael Fried, Professor, MD

  University Hospital Zurich, Division of Gastroenterology and Hepatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Steingoetter

CONTACT

+41 (0)44 255 5684; andreas.steingoetter@usz.ch

Michael Fried, Professor, MD

CONTACT

+41 (0)44 255 2401; michael.fried@usz.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2011
• First Posted: October 6, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 12, 2011

Record last verified: 2011-10

Locations

CH (1)