Selective Bilateral Laryngeal Reinnervation as a Secondary Treatment in Case of Bilateral Vocal Fold Paralysis

Bilateral Vocal Fold Paralysis Clinical Trial

— SEQLAR  

Official title:

Selective Bilateral Laryngeal Reinnervation as a Secondary Treatment in Case of Bilateral Vocal Fold Paralysis: Analysis of Phonatory and Ventilatory Results

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02400008
• Other study ID #: 2011/120/HP
• Status: Recruiting
• Phase: N/A
• First received: March 23, 2015
• Last updated: June 13, 2017
• Start date: November 2014
• Est. completion date: January 2018

Study information

• Verified date: June 2017
• Source: University Hospital, Rouen
• Contact: Jean-Paul MARIE, Pr
• Phone: +3323288
• Email: jean-paul.marie[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Selective laryngeal bilateral reinnervation as a secondary treatment in patients with bilateral vocal fold paralysis, previously treated by endoscopy, without residual arytenoids ankylosis.

The surgical procedure is : functional reinnervation with the upper root of one phrenic nerve, is used for reinnervation of both cricoarytenoid muscles (laryngeal inspiratory muscles), and simultaneous reinnervation of adductor laryngeal muscles is performed by right and left thyro -hyoid nerves (coming from the hypoglossi) on both sides.

Results are obtained after 6 to 9 months delay. In case of good inspiratory arytenoid abduction, and residual dysphonia, a secondary vocal fold medialization is done by an endoscopic approach 12 months after reinnervation (included in the protocol).

Improvement is expected in voice and breathing, without aspiration.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patient with Bilateral vocal fold paralysis in a closure position 6 months to 36 months before.

• Patient who has been treated by endoscopic treatment without satisfying result (voice or breathing).

• Patient with passive mobile arytenoid at least on one side

• Tracheostomized or not

• Age > 18 years old

• Good general situation

Exclusion Criteria:

• Long term vocal fold paralysis (more than 3 years with strong denervation)

• Ary-cricoid ankylosis or synechiae

• Age >75 years

• Anaesthesiologist contra indication

• Strong respiratory disease history

• Severe coagulation troubles

• Ongoing neoplasia disease

• Cardiac pace maker

• Pregnant woman or without contraception

• Impairment of the freedom

Related Conditions & MeSH terms

• Bilateral Vocal Fold Paralysis
• Paralysis

Intervention

Procedure:
• Surgery for bilateral laryngeal reinnervation
Surgery for bilateral laryngeal reinnervation assessed for patient with bilateral vocal fold paralysis

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal phonation time	Maximal phonation time will be assessed at 18 Months	18 Months
Secondary	Voice quality assessed using quality of life questionnaire	Voice quality will be assessed using quality of life questionnaire, computerized analysis, swallowing scores	18 Months
Secondary	Voice quality assessed using computerized analysis	Voice quality will be assessed using computerized analysis	18 Months
Secondary	Voice quality assessed using swallowing scores	Voice quality will be assessed using swallowing scores	18 Months