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Laryngeal Nerve InjuriesNCT06002984

Effectiveness of Intraoperative Neuromonitoring of External Branch of Superior Laryngeal Nerve in Thyroid Surgery

A study testing Using Neuromonitoring to find EBSLN in people with Laryngeal Nerve Injuries and Thyroidectomy, run by Seoul National University Hospital at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The frequent occurrence of impaired function in the external branch of the superior laryngeal nerves following thyroid surgery is recognized as a prevalent complication leading to a diminished quality of life. Read more about this study

Who is it for?
Ages 19 to 79 years
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
94 participants
Where
1 siteSouth Korea
Study dates
24 Nov 2023to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 19 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who are scheduled to undergo thyroid surgery
  • Patients who understand and agree to take part in this study

Who cannot join

  • If the thyroid tumor is suspected to invade adjacent organs (esophagus, trachea, carotid artery, jugular vein etc.)
  • Patients who are required with lateral compartment neck dissection
  • Patients with recurrent thyroid cancer
  • Patients with palsy of recurrent laryngeal nerve or superior laryngeal nerve external branch in the past or present
  • Patients with a history of vocal cord and larynx disease
  • History of hyperthyroidism (e.g., Graves' disease)
Show all 10Show fewer
  • Taking anticoagulants (aspirin, warfarin, etc.) before surgery
  • Disorders of coagulation
  • In the case of women, pregnant women and breastfeeding patients
  • Patients judged inappropriate by clinical trial researcher

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hye Lim Bae, M.D contact

82-10-2664-6571

gpfla1206@gmail.com

South Korea1 site, 1 recruiting

  • Seoul National University Hospital

    Seoul

    Su-jin Kim, su.jin.kim.md@gmail.com

    Su-jin Kim

    Recruiting

Other trials in South Korea

About this study

Official title: Effectiveness of Intraoperative Neuromonitoring to Identify and Preserve External Branch of Superior Laryngeal Nerve During Thyroid Surgery

The frequent occurrence of impaired function in the external branch of the superior laryngeal nerves following thyroid surgery is recognized as a prevalent complication leading to a diminished quality of life. The objective of this randomized controlled trial (RCT) is to assess the efficacy of neuromonitoring during thyroid surgery in order to safeguard the integrity of these nerves.

Read the detailed description

With increased interest in quality of life after thyroidectomy, preservation of proper vocal cord function and voice quality is an important issue in thyroid surgery. External branch of the superior laryngeal nerve (EBSLN) and recurrent laryngeal nerve (RLN) are crucial organs for innervation and integration of laryngeal muscular system. The EBSLN innervates the cricothyroid muscle (CTM), which is important in adjusting the tension and length of the vocal cords. Damage of the EBSLN leads to CTM dysfunction, resulting in difficulty with high pitch phonation and decreased pitch range and reduced voice projection, which are important for voice professionals. As the intraoperative neuromonitoring was utilized as an adjunctive and objective tool to confirm the nerve presence and integrity, application of the intraoperative neuromonitoring system to confirm EBSLN function pre- and post-dissection of the upper thyroid pole can be regarded as an effective method to preserve cricothyroid muscle function. However, it remains unclear whether there is any intraoperative neuromonitoring techniques-added value to the clinical outcome of thyroidectomy in terms of identification of EBSLN and preserved voice performance. Therefore, this study could provide strong evidence of the application of the intraoperative neuromonitoring during thyroid surgery to identify and preserve EBSLN function.

Being tested
Using Neuromonitoring to find EBSLN
Keywords
External branch of the superior Laryngeal Nerve
Medical subject headings
Laryngeal Nerve Injuries, Dysphonia

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 groups in NCT06002984
Study groupRoleWhat they receive
Using neuromonitoring to find EBSLNExperimentalWith neuromonitoring of the EBSLN using nerve monitoring system Intervention Device: Neuromonitoring to find EBSLN
Receives: Device: Using Neuromonitoring to find EBSLN
No using neuromonitoring to find EBSLNNo interventionWithout 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.

  1. Identification rate of EBSLN

    Visual identification rate, Electrostimulatory identification rate

    Measured: during operation

Secondary outcomes (7)

  1. Change of results about questionnaire for quality of voice

    Voice Handicap Index-10 [0~40], higher scores mean worse voice disorder

    Measured: up to postoperative 1 month, 3 months and 6 months

  2. Changes of Vocal outcome

    Visual Analogue Scales (VAS) [0~100%], 0% = no voice, full disability ; 100% = normal voice

    Measured: up to postoperative 1 month, 3 months and 6 months

  3. Measurements of Vocal function

    Maximum Phonation Time (MPT)

    Measured: up to postoperative 1 month, 3 months and 6 months

  4. Vocal evaluation

    GRBAS (Grade, Rough, Breathy, Asthenia, and Strain)

    Measured: up to postoperative 1 month, 3 months and 6 months

  5. Changes of Vocal fold vibration patterns

    EGG (electroglottography) assessment of voice

    Measured: up to postoperative 1 month, 3 months and 6 months

  6. Changes of Vocal outcome by Computerized Acoustic Analysis

    Multi-Dimensional Voice Program (MDVP)

    Measured: up to postoperative 1 month, 3 months and 6 months

  7. Changes of Voice Pitch

    Real-time pitch (RTP)

    Measured: up to postoperative 1 month, 3 months and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2023
  2. Study start24 Nov 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
94 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06002984
Sponsor's protocol ID
2303-075-1411
Status last verified
Jun 2025
First submitted
10 Aug 2023
Last updated
12 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kim SJ, Lee KE, Oh BM, Oh EM, Bae DS, Choi JY, Myong JP, Youn YK. Intraoperative neuromonitoring of the external branch of the superior laryngeal nerve during robotic thyroid surgery: a preliminary prospective study. Ann Surg Treat Res. 2015 Nov;89(5):233-9. doi: 10.4174/astr.2015.89.5.233. Epub 2015 Oct 28.

    PubMed 26576402

  • Kim JI, Kim SJ, Xu Z, Kwak J, Ahn JH, Yu HW, Chai YJ, Choi JY, Lee KE. Efficacy of Intraoperative Neuromonitoring in Reoperation for Recurrent Thyroid Cancer Patients. Endocrinol Metab (Seoul). 2020 Dec;35(4):918-924. doi: 10.3803/EnM.2020.778. Epub 2020 Dec 23.

    PubMed 33397044

  • Potenza AS, Phelan EA, Cernea CR, Slough CM, Kamani DV, Darr A, Zurakowski D, Randolph GW. Normative intra-operative electrophysiologic waveform analysis of superior laryngeal nerve external branch and recurrent laryngeal nerve in patients undergoing thyroid surgery. World J Surg. 2013 Oct;37(10):2336-42. doi: 10.1007/s00268-013-2148-9.

    PubMed 23838931

  • Barczynski M, Konturek A, Stopa M, Honowska A, Nowak W. Randomized controlled trial of visualization versus neuromonitoring of the external branch of the superior laryngeal nerve during thyroidectomy. World J Surg. 2012 Jun;36(6):1340-7. doi: 10.1007/s00268-012-1547-7.

    PubMed 22402975

  • Jonas J, Bahr R. Neuromonitoring of the external branch of the superior laryngeal nerve during thyroid surgery. Am J Surg. 2000 Mar;179(3):234-6. doi: 10.1016/s0002-9610(00)00308-1.

    PubMed 10827327

  • Babinska D, Barczynski M, Oseka T, Sledzinski M, Lachinski AJ. Comparison of perioperative stress in patients undergoing thyroid surgery with and without neuromonitoring-a pilot study. Langenbecks Arch Surg. 2017 Jun;402(4):719-725. doi: 10.1007/s00423-016-1457-5. Epub 2016 Jun 14.

    PubMed 27299585

  • Cirocchi R, Arezzo A, D'Andrea V, Abraha I, Popivanov GI, Avenia N, Gerardi C, Henry BM, Randolph J, Barczynski M. Intraoperative neuromonitoring versus visual nerve identification for prevention of recurrent laryngeal nerve injury in adults undergoing thyroid surgery. Cochrane Database Syst Rev. 2019 Jan 19;1(1):CD012483. doi: 10.1002/14651858.CD012483.pub2.

    PubMed 30659577

  • Dionigi G, Boni L, Rovera F, Bacuzzi A, Dionigi R. Neuromonitoring and video-assisted thyroidectomy: a prospective, randomized case-control evaluation. Surg Endosc. 2009 May;23(5):996-1003. doi: 10.1007/s00464-008-0098-3. Epub 2008 Sep 21.

    PubMed 18806939

  • Lifante JC, McGill J, Murry T, Aviv JE, Inabnet WB 3rd. A prospective, randomized trial of nerve monitoring of the external branch of the superior laryngeal nerve during thyroidectomy under local/regional anesthesia and IV sedation. Surgery. 2009 Dec;146(6):1167-73. doi: 10.1016/j.surg.2009.09.023.

    PubMed 19958945

Questions about this trial

What is this clinical trial studying?

A study testing Using Neuromonitoring to find EBSLN in people with Laryngeal Nerve Injuries and Thyroidectomy, 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 2 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 12 Jun 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hye Lim Bae, M.D (82-10-2664-6571, gpfla1206@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identification rate of EBSLN (time frame: during operation). 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 NCT06002984, which also lists 9 linked publications.

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 12 Jun 2025.

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