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

Primary Purpose

Thyroid Cancer, Recurrent Laryngeal Nerve Injuries

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Reversed Tracking Method
Sponsored by
Fujian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Cancer focused on measuring external branches of superior laryngeal nerve, thyroidectomy, thyroid cancer

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fujian Medical University Union HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard method

Reversed Tracking Method

Arm Description

Standard method recommended by the guide

Reversed Tracking Method

Outcomes

Primary Outcome Measures

The identification rate of the external branch of the superior laryngeal nerve.
The identification rate of the external branch of the superior laryngeal nerve.

Secondary Outcome Measures

Friedman classification
Anatomical variability of the external branch of the superior laryngeal nerve according to Friedman classification.
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.
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.
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.
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.
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.

Full Information

First Posted
September 9, 2018
Last Updated
November 7, 2018
Sponsor
Fujian Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03680222
Brief Title
Effect of Reversed Tracking Method for Identification of EBSLN in Thyroid Surgery
Official Title
Effect of Reversed Tracking Method of Stimulating Cricothyroid Muscles on the Identification and Protection of EBSLN in Thyroid Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fujian Medical University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer, Recurrent Laryngeal Nerve Injuries
Keywords
external branches of superior laryngeal nerve, thyroidectomy, thyroid cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Different methods of protection of external branches of superior laryngeal nerve
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard method
Arm Type
No Intervention
Arm Description
Standard method recommended by the guide
Arm Title
Reversed Tracking Method
Arm Type
Experimental
Arm Description
Reversed Tracking Method
Intervention Type
Procedure
Intervention Name(s)
Reversed Tracking Method
Intervention Description
Reversed Tracking Method
Primary Outcome Measure Information:
Title
The identification rate of the external branch of the superior laryngeal nerve.
Description
The identification rate of the external branch of the superior laryngeal nerve.
Time Frame
up to 6 months postoperatively
Secondary Outcome Measure Information:
Title
Friedman classification
Description
Anatomical variability of the external branch of the superior laryngeal nerve according to Friedman classification.
Time Frame
up to 6 months postoperatively
Title
videostrobolaryngoscopy
Description
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.
Time Frame
up to 6 months postoperatively
Title
analysis of maximum phonation time (MPT)
Description
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.
Time Frame
up to 6 months postoperatively
Title
voice level (VL)
Description
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.
Time Frame
up to 6 months postoperatively
Title
fundamental frequency (Fo)
Description
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.
Time Frame
up to 6 months postoperatively
Title
voice quality rating on GRBAS scale
Description
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.
Time Frame
up to 6 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria： thyroid papillary cancer patients thyroid adenoma patients tumor diameter less than 4cm patients who require only unilateral thyroid surgery as required by the guidelines Exclusion criteria: The upper pole tumor invades the anterior dorsum and may accumulate the area of the superior laryngeal nerve; Patients who have previously performed head and neck surgery; Preoperative laryngoscopy and sound assessment abnormalities or previous vocal cord surgery history; If there is a language or hearing impairment, the follow-up assessment cannot be completed; The assessment failure of nerve function due to the technical deficiency of the IONM equipment Elimination criteria: Patients with recurrent laryngeal nerve palsy after surgery affect the evaluation of the laryngeal nerve. The patient is asked to withdraw from the follow-up assessment midway.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bo Wang, md
Phone
13705947900
Email
wangbo@fjmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
wenxin zhao, md
Organizational Affiliation
Fujian Medical University Union Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
FuZhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
bo wang, md
Phone
13705947900
Email
wangbo@fjmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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

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