NCT03976011

Brief Summary

One of the major risks of endocrine surgery is recurrent nerve palsy (RNP), leading to vocal folds (VF) immobility. It happens in 5% of cases, leading to high morbidity: dysphonia, aspirations, impossibility to work. Guidelines recommend to systematically perform a nasofibroscopy before and after surgery to check vocal fold mobility. However, due to the decreasing number of specialists, the cost of decontamination, and discomfort of this procedure, these guidelines are insufficiently followed. Transcutaneous Laryngeal Ultrasonography (TLU) appears a good alternative to nasofibroscopy in evaluating VF mobility, as assessed by the recent flourishing literature. Our team is a leader in this research by having developed a dedicated software, which provides objective measures of VF mobility. The aim of the present protocol is to validate the power of TLU for the diagnosis of RNP on a large cohort of patients operated on endocrine surgery. It is a prospective multicentric study that will blindly compare TLU and nasofibroscopy, the latter being the gold standard. TLU is cost effective and painless; its learning curve is fast. If validated, it may be offered as a good alternative to nasofibroscopy in RNP detection and prognosis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 5, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

October 20, 2019

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

June 7, 2023

Status Verified

May 1, 2023

Enrollment Period

4.2 years

First QC Date

May 24, 2019

Last Update Submit

June 6, 2023

Conditions

Recurrent Laryngeal Nerve PalsyPostoperative Dysphonia

Keywords

Postoperative dysphoniaThyroidectomyParathyroidectomyInferior laryngeal nerve palsyTrans laryngeal ultrasonographyQuantitative vocal fold motion evaluationPostoperative recurrent Laryngeal Nerve Palsy

Outcome Measures

Primary Outcomes (1)

  • Diagnostic performance associated with the postoperative quantitative TLU (i.e. measured by asymmetry in vocal cord mobility obtained with our dedicated software of image analysis) for the diagnostic of postoperative recurrent nerve palsy (RNP).

    The diagnostic performance of the postoperative measurement of asymmetry in vocal cord mobility obtained with the quantitative TLU will be evaluated by the area under the roc curve and its 95% confidence interval. The gold standard for diagnosis of postoperative RNP will be the nasofibroscopy performed between Day 1 and Day15.

    Between Day 1(the day after the surgery) and Day 15

Secondary Outcomes (14)

  • Diagnostic performance associated with the postoperative qualitative TLU (i.e. obtained by the operator during TLU, without the use of our dedicated software for the diagnostic of postoperative recurrent nerve palsy (RNP).

    Between Day 1(the day after the surgery) and Day 15

  • Predictive performance associated with the postoperative quantitative TLU for the diagnosis of final recovery of RNP, among subjects with postoperative RNP.

    6 months after surgery

  • Predictive performance associated with the postoperative qualitative TLU for the diagnosis of final recovery of RNP, among subjects with postoperative RNP.

    6 months (e.g. 6 months after surgery)

  • Predictive performance associated with the quantitative TLU performed 6 weeks after surgery for the diagnosis of final recovery of RNP, among subjects with postoperative RNP.

    6 months after surgery

  • Predictive performance associated with the qualitative TLU performed 6 weeks after surgery for the diagnosis of final recovery of RNP, among subjects with postoperative.

    6 months after surgery

  • +9 more secondary outcomes

Other Outcomes (3)

  • Diagnostic performance associated with the postoperative measurements obtained with the interactive software developed by the Mindray company of different points of the laryngeal anatomy for the diagnostic of postoperative recurrent nerve palsy (RNP).

    Between Day 1 (the day after the surgery) and D15

  • Diagnostic performance comparison of the postoperative measure obtained with an interactive software developed by the Mindray company and with quantitative TLU measured by asymmetry in vocal cord mobility with our dedicated software of image analysis.

    Between Day 1 (the day after the surgery) and Day 15

  • Concordance between the postoperative measure obtained with an interactive software developed by the Mindray company and with quantitative TLU (i.e. measured by asymmetry in vocal cord mobility obtained with our dedicated software of image analysis).

    Between Day 1 (the day after the surgery) and Day 15

Study Arms (1)

Transcutaneous Laryngeal Ultrasonography

EXPERIMENTAL

All patients operated on endocrine surgery in the three referral centers and responding to the inclusion criteria will be included after obtaining their writing consent. The gold standard NF will be performed between D1 and D15, as usually performed after these surgeries. TLU will be performed during the same time period by an investigator blind to the NF results. The subject will be his own control, NF and TLU being compared. When facing VF immobility, the subject will benefit from the usual clinical follow up: consultation with NF at 6 weeks and 6 months. TLU will be added to these appointments.

Device: Transcutaneous Laryngeal Ultrasonography

Interventions

Transcutaneous Laryngeal UltrasonographyDEVICE

TLU will be performed during the same time period of The gold standard NF (who is performed as usually after endocrine surgeries) by an investigator blind to the NF results, between D1 and D15. The subject will be his own control, NF and TLU being compared. When facing VF immobility, the subject will benefit from the usual clinical follow up: consultation with NF at 6 weeks and 6 months. TLU will be added to these appointments.

Transcutaneous Laryngeal Ultrasonography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old patient and older
  • Free informed consent of the patient obtained during the preoperative consultation or, failing this, the day before the intervention during the preoperative hospitalization
  • Thyroid / parathyroid surgery scheduled within 3 months, regardless of the indication or extension
  • Affiliation to a social security system (recipient or assign) excluding AME.

You may not qualify if:

  • Known preoperative history of recurrent nerve palsy
  • History of thyroid or parathyroid surgery or cervicotomy for another pathology
  • History of laryngeal tumor or vocal folds
  • Patient under guardianship or curatorship or deprived of liberty or under judicial protection
  • Pregnant, breastfeeding and parturient women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU Nantes - Clinique de chirurgie Digestive et Endocrinienne

Nantes, 44093, France

RECRUITING

Hopital Pitié-Salpêtrière

Paris, 75013, France

TERMINATED

Hopital Avicenne

Paris, France

RECRUITING

Hopital Cochin

Paris, France

TERMINATED

Institut Gustave Roussy (IGR)

Villejuif, France

RECRUITING

Related Publications (2)

  • Bergeret-Cassagne H, Lazard DS, Lefort M, Hachi S, Leenhardt L, Menegaux F, Russ G, Tresallet C, Frouin F. Sonographic Dynamic Description of the Laryngeal Tract: Definition of Quantitative Measures to Characterize Vocal Fold Motion and Estimation of Their Normal Values. J Ultrasound Med. 2017 May;36(5):1037-1044. doi: 10.7863/ultra.16.05014. Epub 2017 Jan 10.

    PMID: 28072470BACKGROUND

  • Lazard DS, Bergeret-Cassagne H, Lefort M, Leenhardt L, Russ G, Frouin F, Tresallet C. Transcutaneous Laryngeal Ultrasonography for Laryngeal Immobility Diagnosis in Patients with Voice Disorders After Thyroid/Parathyroid Surgery. World J Surg. 2018 Jul;42(7):2102-2108. doi: 10.1007/s00268-017-4428-2.

    PMID: 29299645BACKGROUND

MeSH Terms

Conditions

Vocal Cord Paralysis

Condition Hierarchy (Ancestors)

Laryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesVagus Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christophe TRESALLET, MD PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christophe TRESALLET, MD PhD

CONTACT

01 42 17 66 39christophe.tresallet@aphp.fr

Frédérique FROUIN

CONTACT

01 69 86 77 39frederique.frouin@inserm.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2019

First Posted

June 5, 2019

Study Start

October 20, 2019

Primary Completion

January 1, 2024

Study Completion

April 1, 2024

Last Updated

June 7, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(5)