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.
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
- Conditions the study is for
- Laryngeal Nerve Injuries, Thyroidectomy, Voice Change
- 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
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)
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- 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.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Su-jin Kim, su.jin.kim.md@gmail.com
Su-jin Kim
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.
- Conditions
- Laryngeal Nerve Injuries, Thyroidectomy, Voice Change
- 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 group | Role | What they receive |
|---|---|---|
| Using neuromonitoring to find EBSLN | Experimental | With 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 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 rate of EBSLN
Visual identification rate, Electrostimulatory identification rate
Measured: during operation
Secondary outcomes (7)
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
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
Measurements of Vocal function
Maximum Phonation Time (MPT)
Measured: up to postoperative 1 month, 3 months and 6 months
Vocal evaluation
GRBAS (Grade, Rough, Breathy, Asthenia, and Strain)
Measured: up to postoperative 1 month, 3 months and 6 months
Changes of Vocal fold vibration patterns
EGG (electroglottography) assessment of voice
Measured: up to postoperative 1 month, 3 months and 6 months
Changes of Vocal outcome by Computerized Acoustic Analysis
Multi-Dimensional Voice Program (MDVP)
Measured: up to postoperative 1 month, 3 months and 6 months
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.
- First posted21 Aug 2023
- Study start24 Nov 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Laryngeal Nerve InjuriesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 94 participants (estimated)
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
- Investigators
- Su-Jin Kim, M.D, Ph.D, Principal investigator, Seoul National University Hospital
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 26576402Kim 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 33397044Potenza 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 23838931Barczynski 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 22402975Jonas 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 10827327Babinska 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 27299585Cirocchi 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 30659577Dionigi 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 18806939Lifante 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