Recurrent Paralysis of Vocal CordsPhase 3NCT03553342
Efficacy of Oral Corticosteroid Therapy in Recurrent Paralyzes After Thyroidectomy
A Phase 3 study testing Corticoids in people with Recurrent Paralysis of Vocal Cords, run by Poitiers University Hospital at 1 site in France.
Trial summary
Thyroidectomy is a common surgical procedure in France. Recurrent paralysis is one of the main complications. Oral corticosteroid therapy are frequently used at a dosage of 1mg/kg for seven days, in case of recurrent paralysis to obtain remobilization as early as possible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Paralysis of Vocal Cords
- What is being tested?
- Corticoids
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteFrance
- Study dates
- 11 Sep 2018to 11 Jan 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for simple total thyroidectomy or lobo-isthmectomy
- Patients over eighteen years old
- Free subject, whitout tutorship or curatorship or subordination
- Informed consent and signed by the patient after clear and fair information about the study.
Who cannot join
- Patients operated on a total thyroidectomy with médiastino-recurrent dissection for cancer etiology
- Patients with preoperative recurrent paralysis
- Patients with hypersensitivity to prednisolone or any of the excipients.
- Patients with contraindication to use Solupred
- Patients with anti-inflammatory of acetylsalicylic acid
- Patient with evolving virosis (hepatitis, herpes, chicken pox, zoster)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Poitiers
Poitiers
Xavier DUFOUR, DR, 05.49.44.60.38, xavier.dufour@chu-poitiers.fr
Florent CARSUZAA, florent.carsuzaa@gmail.com
About this study
Thyroidectomy is a common surgical procedure in France. Recurrent paralysis is one of the main complications. Oral corticosteroid therapy are frequently used at a dosage of 1mg/kg for seven days, in case of recurrent paralysis to obtain remobilization as early as possible.
The main objective is to evaluate the efficacy of oral corticosteroid therapy in remobilization of vocal cords at seven days in patients with unilateral recurrent paralysis after thyroidectomy.
- Conditions
- Recurrent Paralysis of Vocal Cords
- Being tested
- Corticoids, Placebo
- Medical subject headings
- Vocal Cord Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorticoidsDrug
Patients will receive corticosteroids therapy: 1mg/kg of prednisolone daily for seven days.
PlaceboOther
Patients will receive placebo for seven days.
| Study group | Role | What they receive |
|---|---|---|
| Corticoids | Experimental | Not described Receives: Drug: Corticoids |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of oral corticosteroid in remobilization of vocal cords at seven days for patients with unilateral recurrent laryngeal nerve palsy after thyroidectomy
evaluated by naso fibroscope inspection
Measured: Seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start11 Sep 2018
- Primary completion11 Sep 2021 (estimated)
- Study completion11 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Paralysis of Vocal CordsStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553342
- Sponsor's protocol ID
- THYRCOR
- Status last verified
- Jan 2021
- First submitted
- 23 May 2018
- Last updated
- 29 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Carvajal-Alegria E, Girault N, Donatini G, Frasca D, Tonnerre D, Cosset T, Rulliere A, Lebreton JP, Dufour X, Carsuzaa F. Oral Corticosteroids in Vocal Fold Paralysis After Thyroid Surgery: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2025 Sep 1;151(9):874-880. doi: 10.1001/jamaoto.2025.2169.
PubMed 40773211
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Corticosteroid Therapy in Recurrent Paralyzes After Thyroidectomy
- ClinicalTrials.gov ID
- NCT03553342
- Acronym / sponsor ID
- THYRCOR
- Conditions
- Recurrent Paralysis of Vocal Cords
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- 11 Sep 2021 (estimated)
- Study completion
- 11 Jan 2022 (estimated)
- First posted
- 12 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Thyroidectomy is a common surgical procedure in France. Recurrent paralysis is one of the main complications. Oral corticosteroid therapy are frequently used at a dosage of 1mg/kg for seven days, in case of recurrent paralysis to obtain remobilization as early as possible.
The main objective is to evaluate the efficacy of oral corticosteroid therapy in remobilization of vocal cords at seven days in patients with unilateral recurrent paralysis after thyroidectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corticoids | Experimental | Drug: Corticoids |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for simple total thyroidectomy or lobo-isthmectomy
- Patients over eighteen years old
- Free subject, whitout tutorship or curatorship or subordination
- Informed consent and signed by the patient after clear and fair information about the study.
Key exclusion criteria (6 listed)
- Patients operated on a total thyroidectomy with médiastino-recurrent dissection for cancer etiology
- Patients with preoperative recurrent paralysis
- Patients with hypersensitivity to prednisolone or any of the excipients.
- Patients with contraindication to use Solupred
- Patients with anti-inflammatory of acetylsalicylic acid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CorticoidsPatients will receive corticosteroids therapy: 1mg/kg of prednisolone daily for seven days. | Drug | Corticoids |
| PlaceboPatients will receive placebo for seven days. | Other | Placebo |
Primary outcome
Evaluate the efficacy of oral corticosteroid in remobilization of vocal cords at seven days for patients with unilateral recurrent laryngeal nerve palsy after thyroidectomy
Time frame: Seven days
evaluated by naso fibroscope inspection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Derived from this study: PubMed 40773211Carvajal-Alegria E, Girault N, Donatini G, Frasca D, Tonnerre D, Cosset T, Rulliere A, Lebreton JP, Dufour X, Carsuzaa F. Oral Corticosteroids in Vocal Fold Paralysis After Thyroid Surgery: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2025 Sep 1;151(9):874-880. doi: 10.1001/jamaoto.2025.2169.
Related trials for Recurrent Paralysis of Vocal Cords
Not yet recruiting
Endotracheal Tube Versus Transcartilage Needle Electrodes for Nerve Monitoring in Thyroid Surgery
Thyroid Diseases, Recurrent Laryngeal Nerve Injury
Not yet recruiting
Recurrent Laryngeal Nerve Monitoring During Pediatric Aerodigestive Tract and Cardiac Surgery
Unilateral Vocal Cord Paralysis, Unilateral Vocal Cord Paresis
Not yet recruitingPhase 1
Single Dose 4-Aminopyridine for Diagnosing Recurrent Laryngeal Nerve Paralysis Continuity After Trauma
Vocal Cord Paralysis, Recurrent Laryngeal Nerve Palsy
RecruitingObservational study
Detection of Vocal Fold Motion Impairment on Noninvasive Positive Pressure
Vocal Cord Dysfunction, Vocal Cord Paralysis
Active, not recruitingObservational study
CT and Endoscopic Biopsy Image-Based Deep Learning for Predicting Left Recurrent Laryngeal Nerve Lymph Node Metastasis in Esophageal Cancer
Esophageal Squamous Cell Cancer (SCC), Recurrent Laryngeal Nerve Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Corticoids in people with Recurrent Paralysis of Vocal Cords, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xavier DUFOUR, Pr (0549444328 ext. +33, xavier.dufour@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the efficacy of oral corticosteroid in remobilization of vocal cords at seven days for patients with unilateral recurrent laryngeal nerve palsy after thyroidectomy (time frame: Seven days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03553342, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.