NCT03976011|Unknown
Post Thyroidectomy Echographic Method for Study of Vocal Fold Motion
VOCALE
Validation and Optimization Methods for a Quantitative Characterization of Motion Abnormalities of the Larynx With Echography
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VOCALE
Validation and Optimization Methods for a Quantitative Characterization of Motion Abnormalities of the Larynx With Echography
Sponsor study identifier
Secondary identifiers
REGISTRY · IDRCB
interventional
500
1 country
5
Study Start
October 20, 2019
Actual (reported)Primary Completion
January 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 24, 2019
Actual (reported)June 5, 2019
Actual (reported)October 20, 2019
Actual (reported)January 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
CHU Nantes - Clinique de chirurgie Digestive et Endocrinienne
Nantes, 44093, France
Hopital Pitié-Salpêtrière
Paris, 75013, France
Hopital Avicenne
Paris, France
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.
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.
Christophe TRESALLET, MD PhD
Assistance Publique - Hôpitaux de Paris
First Submitted
May 24, 2019
First Posted
June 5, 2019
Study Start
October 20, 2019
Actual (reported)Primary Completion
January 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
Contact the study team to confirm eligibility.
Hopital Cochin
Paris, France
Institut Gustave Roussy (IGR)
Villejuif, France
Study Completion
April 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 7, 2023
Record last verified: 2023-05
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