Cricopharyngeal Dysfunction in Adults

Cricopharyngeal Dysfunction in Adults: Diagnostic and Therapeutic Effects of Cricopharyngeal Botulinum Toxin (Botox) Injection

The objective of the study, after reviewing the recent literature, is to corroborate the thesis of the authors considering the injection of botulinum toxin as a gesture that is both diagnostic and therapeutic in the disorders of the Upper Esophageal Sphincter and reinforce the results already published with a larger series of patients.

Study Overview

• Status: Unknown
• Conditions: Upper Esophageal Sphincter

• Study Type: Observational
• Enrollment (Anticipated): 28

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67098
    • Recruiting
    • Service ORL et chirurgie cervico-faciale
    • Contact: Philippe Schultz, MD, PhD; Phone Number: 33 3 88 12 76 35; Email: philippe.schultz@chru-strasbourg.fr
    • Principal Investigator: Philippe Schultz, MD, PhD
    • Sub-Investigator: Sophie Gorostis, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

- Subject having at least one injection of botulinum toxin A in the crico-pharyngeal muscle for Upper Esophageal Sphincter dysfunction in the ENT department and cervico-facial surgery of Hautepierre.

Description

Inclusion Criteria:

• Man or woman whose age older than 18 years
• Dysphagia with solids and / or liquids
• Dysfunction of primary or secondary Upper Esophageal Sphincter with indirect video-fibroscopy and / or video-fluoroscopy and / or high resolution pharyngo-oesophageal manometry
• Subject having at least one injection of botulinum toxin A in the crico-pharyngeal muscle for Upper Esophageal Sphincter dysfunction in the ENT department and cervico-facial surgery of Hautepierre.
• Subject who has consented to the use of his data from his medical file for the purpose of this research

Exclusion Criteria:

• Myotomy in the first place
• Refusal of the subject to participate in the study
• Subject under the protection of justice
• Subject under guardianship or curatorship

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Deglutition Handicap Index	The period from January 1st, 2017 to December 31st, 2017 will be examined

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Study Director: Philippe Schultz, MD, University Hospital, Strasbourg, france

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: July 11, 2018
• First Submitted That Met QC Criteria: July 16, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 16, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: botulinum toxin; Cricopharyngeal dysfunction; Upper Esophageal Sphincter; Cricopharyngeal botulinum toxin injection
• Other Study ID Numbers: 7053

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No