Carcinoma, Papillary, FollicularNCT03773120
Effectiveness of Intraoperative Neuromonitoring of External Branch of Superior Laryngeal Nerve During Thyroid Surgery
A study testing Using Neuromonitoring to find EBSLN in people with Carcinoma, Papillary, Follicular, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The paralysis of the external branch of superior laryngeal nerves after thyroid surgery is known to be a common complication resulting in poor quality of life. Aim of this randomized control trial(RCT) is to evaluate effectiveness of neuromonitoring during thyroid surgery for the preservation of these nerves. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Carcinoma, Papillary, Follicular
- What is being tested?
- Using Neuromonitoring to find EBSLN
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Apr 2018to 23 Jul 2019
- Phase
- Interventional
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- planned open thyroidectomy
- acceptable clinical laboratory tests
- understand clinical trials
- no significant past medical history
Who cannot join
- planned radical neck dissection
- hyperthyroidism history
- history of laryngeal nerve palsy
- laryngeal disease history
- uncontrolled hypertension or diabetes mellitus or heart disease
- anticoagulation or antiplatelet medication
- stroke history
- participated another clinical trials in 30days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Intraoperative Neuromonitoring of the External Branch of the Superior Laryngeal Nerve During Thyroid Surgery
The paralysis of the external branch of superior laryngeal nerves after thyroid surgery is known to be a common complication resulting in poor quality of life. Aim of this randomized control trial(RCT) is to evaluate effectiveness of neuromonitoring during thyroid surgery for the preservation of these nerves.
Read the detailed description
The external branch of superior laryngeal nerves(EBSLNs) are important for voice quality. Injury to this nerve during thyroid surgery can manifest as ipsilateral paralysis of the cricothyroid muscle. Clinical symptoms may include: hoarseness, breathy voice, an increase in the rate of throat clearing, vocal fatigue, or diminished vocal frequency range, especially with regards to raising pitch. The amount of EBSLNs identified intraoperatively varies from 10% to 80%, while the rate of EBSLN injury reported in the literature is between 5% and 28%, depending on different evaluation methods. Advances in intraoperative neuromonitoring techniques would allow for EBSLN identification during thyroid surgery. However, there is controversy regarding usefulness in preserving EBSLN function using nerve monitoring system. The aim of the study is to evaluate effectiveness of neuromonitoring during thyroid surgery for the preservation of EBSLNs.
- Conditions
- Carcinoma, Papillary, Follicular
- Being tested
- Using Neuromonitoring to find EBSLN
- Keywords
- superior laryngeal nerve
- Medical subject headings
- Carcinoma, Papillary, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using Neuromonitoring to find EBSLNDevice
intraoperative neuromonitoring to preserving external branch of superior laryngeal nerve during thyroid surgery
| Study group | Role | What they receive |
|---|---|---|
| Using Neuromonitoring to find EBSLN | Experimental | With Neuromonitoring of the EBSLN using nerve monitoring system Receives: Device: Using Neuromonitoring to find EBSLN |
| No Using Neuromonitoring to find EBSLN | No intervention | Without Neuromonitoring of the EBSLN using nerve monitoring system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of EBSLN during thyroid surgery
Identification rate of EBSLN
Measured: up to postoperative 12 months
Secondary outcomes (2)
Location of EBSLN
Classification of EBSLN according to Cernea classification
Measured: up to postoperative 12 months
Vocal outcome
Voice assessment using voice lab
Measured: up to postoperative 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start6 Apr 2018
- Primary completion23 Jul 2019
- Study completion23 Jul 2019
Why it stopped: Major study protocol changes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Papillary, FollicularStudies of the same condition, open and under way.
- More trials run by Seoul National 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Su-jin Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773120
- Sponsor's protocol ID
- 1708-125-880
- Status last verified
- Jan 2022
- First submitted
- 12 Apr 2018
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Intraoperative Neuromonitoring of the External Branch of the Superior Laryngeal Nerve During Thyroid Surgery
- ClinicalTrials.gov ID
- NCT03773120
- Acronym / sponsor ID
- 1708-125-880
- Conditions
- Carcinoma, Papillary, Follicular
- Keywords
- superior laryngeal nerve
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Major study protocol changes
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 6 Apr 2018 (actual)
- Primary completion
- 23 Jul 2019 (actual)
- Study completion
- 23 Jul 2019 (actual)
- First posted
- 12 Dec 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.
The paralysis of the external branch of superior laryngeal nerves after thyroid surgery is known to be a common complication resulting in poor quality of life. Aim of this randomized control trial(RCT) is to evaluate effectiveness of neuromonitoring during thyroid surgery for the preservation of these nerves.
Detailed description
The external branch of superior laryngeal nerves(EBSLNs) are important for voice quality. Injury to this nerve during thyroid surgery can manifest as ipsilateral paralysis of the cricothyroid muscle. Clinical symptoms may include: hoarseness, breathy voice, an increase in the rate of throat clearing, vocal fatigue, or diminished vocal frequency range, especially with regards to raising pitch. The amount of EBSLNs identified intraoperatively varies from 10% to 80%, while the rate of EBSLN injury reported in the literature is between 5% and 28%, depending on different evaluation methods. Advances in intraoperative neuromonitoring techniques would allow for EBSLN identification during thyroid surgery. However, there is controversy regarding usefulness in preserving EBSLN function using nerve monitoring system. The aim of the study is to evaluate effectiveness of neuromonitoring during thyroid surgery for the preservation of EBSLNs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Using Neuromonitoring to find EBSLN | Experimental | Device: Using Neuromonitoring to find EBSLNWith Neuromonitoring of the EBSLN using nerve monitoring system |
| No Using Neuromonitoring to find EBSLN | No intervention | –Without Neuromonitoring of the EBSLN using nerve monitoring system |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- planned open thyroidectomy
- acceptable clinical laboratory tests
- understand clinical trials
- no significant past medical history
Key exclusion criteria (8 listed)
- planned radical neck dissection
- hyperthyroidism history
- history of laryngeal nerve palsy
- laryngeal disease history
- uncontrolled hypertension or diabetes mellitus or heart disease
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 |
|---|---|---|
| Using Neuromonitoring to find EBSLNintraoperative neuromonitoring to preserving external branch of superior laryngeal nerve during thyroid surgery | Device | Using Neuromonitoring to find EBSLN |
Primary outcome
Identification of EBSLN during thyroid surgery
Time frame: up to postoperative 12 months
Identification rate of EBSLN
2 secondary outcomes
Location of EBSLN
Time frame: up to postoperative 12 months
Vocal outcome
Time frame: up to postoperative 12 months
Results and safety
The study was stopped early (reason given: Major study protocol changes). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Carcinoma, Papillary, Follicular
RecruitingObservational study
Studies on Tumors of the Thyroid
Hurthle Cell Thyroid Cancer, Tall Cell Variant Thyroid Cancer
Active, not recruitingPhase 3
A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy
Differentiated Thyroid Cancer
Not yet recruiting
Personalized Cancer Support (Thrive Track) to Manage the Emotional Needs of Young Adults With Thyroid, Melanoma and Testicular Cancer, PerCS-YA Trial
Differentiated Thyroid Gland Carcinoma, Malignant Testicular Neoplasm
Not yet recruitingObservational study
Bethesda Classification and Risk Stratification in Differentiated Thyroid Carcinoma
Differentiated Thyroid Carcinoma, Papillary Thyroid Carcinoma
Active, not recruitingPhase 2
PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer
Thyroid Cancer, Thyroid Cancer, Follicular
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using Neuromonitoring to find EBSLN in people with Carcinoma, Papillary, Follicular, run by Seoul National University Hospital at 1 site in South Korea.
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 8 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: stopped early, as of the sponsor's last update on 28 Jan 2022. 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 South Korea. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Major study protocol changes). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of EBSLN during thyroid surgery (time frame: up to postoperative 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2022.