Awake Transnasal Laser-assisted Surgery (TNLS) and Microlaryngeal Surgery for Vocal Cord Cyst

Официальное название

Randomized Controlled Trial of Awake Transnasal Laser-assisted Surgery (TNLS) and Microlaryngeal Surgery for Vocal Cord Cyst

Обзор

This is a prospective randomised controlled trial conducted at two tertiary referral hospitals in Hong Kong to compare the clinical and functional outcomes of office-based awake transnasal laser-assisted laryngeal surgery (TNLS) under local anesthesia to traditional microlaryngeal surgery for vocal cord cyst under general anesthesia.

Подробное описание

The aim of the study is to prospectively compare the functional and clinical outcomes of TNLS under local anesthesia and MLS under general anesthesia in managing vocal cord cysts.

Office-based awake transnasal laser-assisted surgery (TNLS) has been gaining popularity in treating different laryngeal lesions, with the advantages of avoiding general anesthetic risks and minimizing healthcare-related costs. In addition, the general waiting time for surgeries under general anesthesia in public hospitals is getting longer due to the increasing population and limited resources. The investigators have recently conducted a novel randomized controlled trial in 2021-2022 comparing the functional and cost-effectiveness of traditional microlaryngeal surgery (MLS) under general anesthesia and TNLS for benign laryngeal lesions (vocal cord polyps, nodules, cysts, granuloma and Reinke's edema), and found that TNLS was superior to MLS in terms of length of stay, intraoperative complications, perioperative throat discomfort and hospital costs; while it was equivalent to MLS in terms of functional outcome, operative time and recurrence rate. However, since the previous study's main goal was to compare TNLS to MLS in a macroscopic perspective in terms of functional outcomes and cost-effectiveness, it had included a wide variety of benign laryngeal lesions, and different vocal cord lesions may respond differently to laser surgery.

Vocal cord cyst is a fluid-filled sac inside the vocal cord, with 2 subtypes: 1) Epidermoid cyst due to epithelial inclusion 2) Mucous retention cyst due to glandular ductal obstruction. Vocal cord cysts typically do not resolve with voice therapy, and are traditionally excised with microlaryngeal surgery with microflap technique or marsupialization. In our previous RCT study, subgroup analysis did not show a significant difference of vocal cord cyst recurrence in both TNLS and MLS group. However, the investigators' cohort had a higher overall vocal cord cyst recurrence rate (13.8%) compared to historic cohort rate of 2.2-8.7% , which may be accounted by that the vocal cord cysts were ablated and marsupialized instead of removed in the TNLS group. Nevertheless, a recent case series by Gao and colleagues showed a good functional outcome of awake KTP-laser marsupialization in selected cases. A larger cohort is warranted to compare TNLS to MLS for vocal cord cyst. Therefore, the investigators would like to conduct a randomized controlled trial to compared tradition MLS surgery to TNLS, with hypothesis that TNLS would be non-inferior to traditional microlaryngeal surgery in benign laryngeal lesions, and with its additional benefits on minimization of anesthetic risks and hospital expenses, hopefully to expand its further application.

Вмешательства

• Процедура Awake transnasal laser-assisted surgery (TNLS)
  For TNLS, patients are admitted to the day center on the same morning or afternoon of the surgery with fasting prior 6 hours. After local anesthesia application, a 445nm blue laser is introduced via a working channel of bronchoscope and laser ablation of vocal cord cyst is performed. During the operation, patient will receive continuous SpO2 monitoring with regular blood pressure monitoring. After the procedure, patients are kept nil-by-mouth for 2 hours until anesthesia wears off, meanwhile wit
• Процедура Microlaryngeal surgery (MLS)
  For traditional MLS under general anesthesia, after general anesthesia and intubation with microlaryngeal tube, the patient would be positioned on head-ring support for better alignment and access to glottis. A laryngoscope will be inserted transorally under direct vision and suspended. Vocal cord cysts are visualized with microscope, and removed with microsurgery instruments with microflap technique and sent for routine section. After the surgery, the patient is kept nil-by-mouth until fully aw

Первичные конечные точки

• Voice-Handicap Index (VHI-30) [Срок оценки: From enrolment to post-operative 1year]

Вторичные конечные точки (12)

• Perceptual evaluation of voice [Срок оценки: From enrolment to post-operative 1year]
• Acoustic voice analysis - Noise-to-Harmonic ratio (NHR) [Срок оценки: From enrolment to post-operative 1year]
• Acoustic voice analysis - Jitter [Срок оценки: From enrolment to post-operative 1year]
• Acoustic voice analysis - Shimmer [Срок оценки: From enrolment to post-operative 1year]
• Aerodynamic measure of voice [Срок оценки: From enrolment to post-operative 1year]
• Visual analog scale (VAS) [Срок оценки: From enrolment to post-operative 1year]
• Videostroboscopy - Mucosal wave pattern [Срок оценки: From enrolment to post-operative 1year]
• Videostroboscopy - Vocal fold closure [Срок оценки: From enrolment to post-operative 1year]
• Procedure-oriented outcomes - Reoperation [Срок оценки: From perioperative period to post-operative 1 year]
• Procedure-oriented outcomes - Disease recurrence [Срок оценки: From perioperative period to post-operative 1 year]
• Procedure-oriented outcomes - Length of hospital stay [Срок оценки: From perioperative period to post-operative 1 year]
• Procedure-oriented outcomes - Surgical complications in Clavien-Dindo classification [Срок оценки: From perioperative period to post-operative 1 year]

Критерии участия

Критерии включения

• Patients with vocal cord cysts
• older than 18-year-old
• able to independently provide consent
• able to tolerate flexible laryngoscopy would be recruited

Критерии исключения

• under 18-year-old
• unable to independently give an informed consent
• unable to tolerate flexible laryngoscopy
• allergic to local anesthesia
• had unfavorable anatomy such as prolapsing epiglottis precluding adequate visualization, extensive lesions and an expected difficult operation as judged by the surgeons
• with pathologies other than vocal cord cyst

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• The Chinese University of Hong Kong — Гонконг

Публикации

• Misono S, Yueh B, Stockness AN, House ME, Marmor S. Minimal Important Difference in Voice Handicap Index-10. JAMA Otolaryngol Head Neck Surg. 2017 Nov 1;143(11):1098-1103. doi: 10.1001/jamaoto.2017.1621. PMID 28973078
• Ng E, Law T, Tang EC, Ho FN, Tong MC, Lee KY. The Cutoff Point and Diagnostic Accuracy of the Voice Handicap Index in Cantonese-Speaking Population. J Voice. 2021 Mar;35(2):163-168. doi: 10.1016/j.jvoice.2020.09.021. Epub 2020 Oct 9. PMID 33046276
• Gao WZ, Abu-Ghanem S, Reder LS, Amin M, Johns MM. A Novel Approach to Vocal Fold Mucous Retention Cysts: Awake KTP Laser-Assisted Marsupialization. J Voice. 2022 Jul;36(4):570-573. doi: 10.1016/j.jvoice.2020.07.028. Epub 2020 Aug 22. PMID 32843259
• Gocal WA, Tong JY, Maxwell PJ, Sataloff RT. Systematic Review of Recurrence Rates of Benign Vocal Fold Lesions Following Surgery. J Voice. 2025 May;39(3):787-798. doi: 10.1016/j.jvoice.2022.10.015. Epub 2022 Dec 10. PMID 36513559
• Hsu CM, Armas GL, Su CY. Marsupialization of vocal fold retention cysts: voice assessment and surgical outcomes. Ann Otol Rhinol Laryngol. 2009 Apr;118(4):270-5. doi: 10.1177/000348940911800406. PMID 19462847
• Courey MS, Gardner GM, Stone RE, Ossoff RH. Endoscopic vocal fold microflap: a three-year experience. Ann Otol Rhinol Laryngol. 1995 Apr;104(4 Pt 1):267-73. doi: 10.1177/000348949510400402. PMID 7717615
• Tam AKY, Leung NMW, Lee SKJ, Wei Y, Hu Y, Chan JYK, Law T. Randomized Controlled Trial of Awake Transnasal Laser-Assisted Surgery for Benign Laryngeal Lesions. Laryngoscope. 2024 Aug;134(8):3732-3740. doi: 10.1002/lary.31481. Epub 2024 May 10. PMID 38727019
• Schimberg AS, Wellenstein DJ, van den Broek EM, Honings J, van den Hoogen FJA, Marres HAM, Takes RP, van den Broek GB. Office-based vs. operating room-performed laryngopharyngeal surgery: a review of cost differences. Eur Arch Otorhinolaryngol. 2019 Nov;276(11):2963-2973. doi: 10.1007/s00405-019-05617-z. Epub 2019 Sep 5. PMID 31486936

Идентификаторы

NCT: NCT06703515 · NTEC-2023-624

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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