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

Thyroidectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06002984
• Other study ID #: 2303-075-1411
• Status: Recruiting
• Phase: N/A
• Start date: November 24, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: Seoul National University Hospital
• Contact: Hye Lim Bae, M.D
• Phone: 82-10-2664-6571
• Email: gpfla1206[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 79 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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)
• 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

Related Conditions & MeSH terms

• Thyroidectomy

Intervention

Device:
• Using Neuromonitoring to find EBSLN
intraoperative neuromonitoring to preserving external branch of superior laryngeal nerve during thyroid surgery

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification rate of EBSLN	Visual identification rate, Electrostimulatory identification rate	during operation
Secondary	Change of results about questionnaire for quality of voice	Voice Handicap Index-10 [0~40], higher scores mean worse voice disorder	up to postoperative 1 month, 3 months and 6 months
Secondary	Changes of Vocal outcome	Visual Analogue Scales (VAS) [0~100%], 0% = no voice, full disability ; 100% = normal voice	up to postoperative 1 month, 3 months and 6 months
Secondary	Measurements of Vocal function	Maximum Phonation Time (MPT)	up to postoperative 1 month, 3 months and 6 months
Secondary	Vocal evaluation	GRBAS (Grade, Rough, Breathy, Asthenia, and Strain)	up to postoperative 1 month, 3 months and 6 months
Secondary	Changes of Vocal fold vibration patterns	EGG (electroglottography) assessment of voice	up to postoperative 1 month, 3 months and 6 months
Secondary	Changes of Vocal outcome by Computerized Acoustic Analysis	Multi-Dimensional Voice Program (MDVP)	up to postoperative 1 month, 3 months and 6 months
Secondary	Changes of Voice Pitch	Real-time pitch (RTP)	up to postoperative 1 month, 3 months and 6 months