Post Thyroidectomy Echographic Method for Study of Vocal Fold Motion

NCT ID: NCT03976011

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-20
• Study Completion Date: 2024-04-30

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.

Detailed Description

The rationale of this study is that Transcutaneous Laryngeal Ultrasonography (TLU) may be a relevant and reliable tool in assessing vocal folds (VF) paralysis secondary to endocrine surgery (thyroid and parathyroid surgery). According to the literature and to our own publications, subjective impression of VF (im)mobility seems sufficient to diagnose a paralysis. However, the investigators think that objective measures, based on a dedicated semi-automatic software, may offer a much powerful implement and needs to be compared to the gold standard technique, i.e. the nasofibroscopy (NF), in a large prospective multicentric cohort.

In a preliminary study, the investigators described TLU anatomical landmarks first in an ex vivo study and secondary in a prospective study based on 50 patients with VF paralysis compared to 50 controls. These three landmarks, the two arytenoids and the anterior insertion of the two vocal folds on the thyroid cartilage, are easy to recognize, and independent of the postoperative delay and the person performing TLU. They define two symmetrical hemi-larynges in healthy subjects. The investigators designed an original software, aiming at offering two quantitative criteria of laryngeal mobility and symmetry, taking into account motion symmetry (symmetry index) and amplitude (mobility index) of the two hemi-larynges. When a subject presented with a unilateral VF paralysis, the mean symmetry index was significantly larger compared to the control group (20.4% ±13.8% versus 6.7% ±4.7%, p<0.0001) and the mean lower mobility index was significantly smaller (2.2% ±17.4% versus 20.5% ±14.8%, p<0.0001). The sensitivity and specificity of this first version of our automatized protocol were 82%.

The aim of the present study is to validate TLU as an alternative to NF in a large independent cohort of patients operated on endocrine surgery. The main goal is to improve the sensitivity and specificity of the objective measures and implement new parameters in the software. By a ready to use tool, the investigators would like to offer the opportunity to any practitioner to assess and quantify VF (im)mobility with their usual US machine.

The subjects will be recruited in the three different clinical centers, highly specialized in endocrine surgery. The aim of 500 subjects included seems feasible thanks to the high activity of these centers. Moreover the latter already have sufficient and qualified staff and technical tools to perform clinical follow up, US, and NF.

The technical acquisition is as follow. The TLU is performed with a 7-14 MHz linear probe, using a portable machine. Subjects are lying on the back, neck slightly extended, with the probe placed over the laryngeal prominence of the thyroid cartilage, including the arytenoids in the axial view. The images are acquired in B-mode, during normal breathing at rest. Typical values for acquisition are: frequency 10 MHz, depth of field of view 4 cm, mechanical index 0.6, gain 45%, dynamic range 85 decibels. A video clip of 10 seconds (30 images per second) is recorded in order to include 5 to 6 complete respiratory cycles. Two images corresponding to physiological abduction and adduction during the same breath cycle are selected. The landmarks, previously described, are selected on the images and tracked by the software.

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.

Conditions

Recurrent Laryngeal Nerve Palsy; Postoperative Dysphonia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Transcutaneous Laryngeal Ultrasonography

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.

Group Type: EXPERIMENTAL

Transcutaneous Laryngeal Ultrasonography

Intervention Type: DEVICE

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.

Interventions

Transcutaneous Laryngeal Ultrasonography

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 18 years old patient and older

2. Free informed consent of the patient obtained during the preoperative consultation or, failing this, the day before the intervention during the preoperative hospitalization

3. Thyroid / parathyroid surgery scheduled within 3 months, regardless of the indication or extension

4. Affiliation to a social security system (recipient or assign) excluding AME.

Exclusion Criteria

1. Known preoperative history of recurrent nerve palsy

2. History of thyroid or parathyroid surgery or cervicotomy for another pathology

3. History of laryngeal tumor or vocal folds

4. Patient under guardianship or curatorship or deprived of liberty or under judicial protection

5. Pregnant, breastfeeding and parturient women

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MINDRAY

UNKNOWN

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christophe TRESALLET, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

CHU Nantes - Clinique de chirurgie Digestive et Endocrinienne

Nantes, , France

Site Status: RECRUITING

Hopital Pitié-Salpêtrière

Paris, , France

Site Status: TERMINATED

Hopital Avicenne

Paris, , France

Site Status: RECRUITING

Hopital Cochin

Paris, , France

Site Status: TERMINATED

Institut Gustave Roussy (IGR)

Villejuif, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Christophe TRESALLET, MD PhD

Role: CONTACT

christophe.tresallet@aphp.fr

01 42 17 66 39

Frédérique FROUIN

Role: CONTACT

frederique.frouin@inserm.fr

01 69 86 77 39

Facility Contacts

Eric MIRALLIE

Role: primary

eric.mirallie@chu-nantes.fr

Christophe TRESALLET, MD

Role: primary

christophe.tresallet@aphp.fr

01 48 95 58 65

Dana HARTL, MD, PhD

Role: primary

dana.hartl@gustaveroussy.fr

References

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.

Reference Type: BACKGROUND

PMID: 28072470 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29299645 (View on PubMed)

Other Identifiers

2018-A02951-54

Identifier Type: REGISTRY

Identifier Source: secondary_id

K170921J

Identifier Type: -

Identifier Source: org_study_id