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

Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03680222
• Other study ID #: IONM diffusion for EBSLN
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: November 2018
• Source: Fujian Medical University
• Contact: Bo Wang, md
• Phone: 13705947900
• Email: wangbo[@]fjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Recurrent Laryngeal Nerve Injuries
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Procedure:
• Reversed Tracking Method
Reversed Tracking Method

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	FuZhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Friedman classification	Anatomical variability of the external branch of the superior laryngeal nerve according to Friedman classification.	up to 6 months postoperatively
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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