Effect of Reversed Tracking Method for Identification of EBSLN in Thyroid Surgery

Effect of Reversed Tracking Method of Stimulating Cricothyroid Muscles on the Identification and Protection of EBSLN in Thyroid Surgery

The feasibility and effectiveness of Reversed Tracking Method for the identification and protection of extralaryngeal nerve branches in thyroid surgery were analyzed. Evidence-based medical evidence was used to evaluate the importance of EBSLN recognition and protection in thyroid surgery.

Study Overview

• Status: Unknown
• Conditions: Thyroid Cancer; Recurrent Laryngeal Nerve Injuries
• Intervention / Treatment: Procedure: Reversed Tracking Method

Detailed Description

The incidence of thyroid cancer in the world is growing rapidly. The current incidence of thyroid cancer in China is about 4.2/100,000, ranking the fourth in the incidence of female malignant tumors. Surgical treatment is the first and most important treatment for thyroid cancer. According to the existing literature, the injury rate of EBSLN in thyroid surgery can be as high as 58%. The quality of sound changes caused by EBSLN injury affects the quality of life of patients after surgery, and even affects the work and career of patients. therefore, seeking better EBSLN protection The method has great social and economic benefits.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fujian
    • FuZhou, Fujian, China, 350001
      • Recruiting
      • Fujian Medical University Union Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria：

1. thyroid papillary cancer patients
2. thyroid adenoma patients
3. tumor diameter less than 4cm
4. patients who require only unilateral thyroid surgery as required by the guidelines

Exclusion criteria:

1. The upper pole tumor invades the anterior dorsum and may accumulate the area of the superior laryngeal nerve;
2. Patients who have previously performed head and neck surgery;
3. Preoperative laryngoscopy and sound assessment abnormalities or previous vocal cord surgery history;
4. If there is a language or hearing impairment, the follow-up assessment cannot be completed;
5. The assessment failure of nerve function due to the technical deficiency of the IONM equipment

Elimination criteria:

1. Patients with recurrent laryngeal nerve palsy after surgery affect the evaluation of the laryngeal nerve.
2. The patient is asked to withdraw from the follow-up assessment midway.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard method; Standard method recommended by the guide
Experimental: Reversed Tracking Method	Procedure: Reversed Tracking Method; Reversed Tracking Method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The identification rate of the external branch of the superior laryngeal nerve.	The identification rate of the external branch of the superior laryngeal nerve.	up to 6 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Friedman classification	Anatomical variability of the external branch of the superior laryngeal nerve according to Friedman classification.	up to 6 months postoperatively
videostrobolaryngoscopy	The voice assessment included pre- and postoperative videostrobolaryngoscopy and analysis of maximum phonation time (MPT), voice level (VL), fundamental frequency (Fo), and voice quality rating on GRBAS scale.	up to 6 months postoperatively
analysis of maximum phonation time (MPT)	The voice assessment included pre- and postoperative videostrobolaryngoscopy and analysis of maximum phonation time (MPT), voice level (VL), fundamental frequency (Fo), and voice quality rating on GRBAS scale.	up to 6 months postoperatively
voice level (VL)	The voice assessment included pre- and postoperative videostrobolaryngoscopy and analysis of maximum phonation time (MPT), voice level (VL), fundamental frequency (Fo), and voice quality rating on GRBAS scale.	up to 6 months postoperatively
fundamental frequency (Fo)	The voice assessment included pre- and postoperative videostrobolaryngoscopy and analysis of maximum phonation time (MPT), voice level (VL), fundamental frequency (Fo), and voice quality rating on GRBAS scale.	up to 6 months postoperatively
voice quality rating on GRBAS scale	The voice assessment included pre- and postoperative videostrobolaryngoscopy and analysis of maximum phonation time (MPT), voice level (VL), fundamental frequency (Fo), and voice quality rating on GRBAS scale.	up to 6 months postoperatively

Collaborators and Investigators

• Sponsor: Fujian Medical University
• Investigators: Study Chair: wenxin zhao, md, Fujian Medical University Union Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Anticipated): September 30, 2019
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: September 9, 2018
• First Submitted That Met QC Criteria: September 19, 2018
• First Posted (Actual): September 21, 2018

Study Record Updates

• Last Update Posted (Actual): November 9, 2018
• Last Update Submitted That Met QC Criteria: November 7, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: thyroid cancer; thyroidectomy; external branches of superior laryngeal nerve
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Wounds and Injuries; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Otorhinolaryngologic Diseases; Craniocerebral Trauma; Trauma, Nervous System; Cranial Nerve Diseases; Laryngeal Diseases; Cranial Nerve Injuries; Vagus Nerve Injuries; Thyroid Diseases; Thyroid Neoplasms; Laryngeal Nerve Injuries; Recurrent Laryngeal Nerve Injuries
• Other Study ID Numbers: IONM diffusion for EBSLN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No