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

NCT06703515 | Not Yet Recruiting

• 1 other identifier: NTEC-2023-624
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vocal Cord Cyst

Keywords

Vocal cord cyst; Transnasal laser surgery; Microlaryngeal surgery; Office based laser surgery; Awake laser laryngeal surgery; Trublue laser

Outcome Measures

Primary Outcomes (1)

• Voice-Handicap Index (VHI-30)

  The primary outcome was to compare the pre- and post-operative Voice-Handicap Index 30 (VHI-30) of TNLS and MLS groups. The VHI-30 is a 30-item self-administered questionnaire, with score range from 0 to 120, and a score of 120 meaning worst voice score. It has been shown to be a reliable measure for voice treatment outcome. It consists of three subscales, namely physical, functional and emotional. It provides an overall measurement of a person's vocal function and how it influences a person's everyday functioning and experience.

  From enrolment to post-operative 1year

Secondary Outcomes (16)

• Perceptual evaluation of voice

  From enrolment to post-operative 1year

• Acoustic voice analysis - Noise-to-Harmonic ratio (NHR)

  From enrolment to post-operative 1year

• Acoustic voice analysis - Jitter

  From enrolment to post-operative 1year

• Acoustic voice analysis - Shimmer

  From enrolment to post-operative 1year

• Aerodynamic measure of voice

  From enrolment to post-operative 1year

Study Arms (2)

Microlaryngeal surgery (MLS)

ACTIVE COMPARATOR

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 awake, and is discharged on same day or the next day depending on the post- operative recovery. Patient will be discharged with voice rest for 3 days.

Procedure: Microlaryngeal surgery (MLS)

Awake transnasal laser-assisted surgery (TNLS)

EXPERIMENTAL

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 with close observation in day ward with continuous SpO2 monitor for 1 hour. Patients will be discharged on the same day of the procedure, with voice rest for 3 days.

Procedure: Awake transnasal laser-assisted surgery (TNLS)

Interventions

Awake transnasal laser-assisted surgery (TNLS) PROCEDURE

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 with close observation in day ward with continuous SpO2 monitor for 1 hour. Patients will be discharged on the same day of the procedure, with voice rest for 3 days.

Awake transnasal laser-assisted surgery (TNLS)

Microlaryngeal surgery (MLS) PROCEDURE

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 awake, and is discharged on same day or the next day depending on the post- operative recovery. Patient will be discharged with voice rest for 3 days.

Microlaryngeal surgery (MLS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (11)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Lin YH, Wang CT, Lin FC, Liao LJ, Lo WC, Cheng PW. Treatment Outcomes and Adverse Events Following In-Office Angiolytic Laser With or Without Concurrent Polypectomy for Vocal Fold Polyps. JAMA Otolaryngol Head Neck Surg. 2018 Mar 1;144(3):222-230. doi: 10.1001/jamaoto.2017.2899.

  PMID: 29346486 BACKGROUND

• Wellenstein DJ, Honings J, Schimberg AS, Schutte HW, Herruer JM, van den Hoogen FJA, Takes RP, van den Broek GB. Office-based CO2 laser surgery for benign and premalignant laryngeal lesions. Laryngoscope. 2020 Jun;130(6):1503-1507. doi: 10.1002/lary.28278. Epub 2019 Sep 9.

  PMID: 31498454 BACKGROUND

• Shoffel-Havakuk H, Sadoughi B, Sulica L, Johns MM 3rd. In-office procedures for the treatment of benign vocal fold lesions in the awake patient: A contemporary review. Laryngoscope. 2019 Sep;129(9):2131-2138. doi: 10.1002/lary.27731. Epub 2018 Dec 21.

  PMID: 30575043 BACKGROUND

Central Study Contacts

Aurora KY Tam, MBBS, MRCSEd

CONTACT

+852-3505 1409; tky369@ha.org.hk

Wing Kei Ng

CONTACT

+852-3505 1409; cherrieng@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 25, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)