Thyroid CancerNCT03680222
Effect of Reversed Tracking Method for Identification of EBSLN in Thyroid Surgery
A study testing Reversed Tracking Method in people with Thyroid Cancer and Recurrent Laryngeal Nerve Injuries, run by Fujian Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Thyroid Cancer, Recurrent Laryngeal Nerve Injuries
- What is being tested?
- Reversed Tracking Method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2018to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- thyroid papillary cancer patients
- thyroid adenoma patients
- tumor diameter less than 4cm
- patients who require only unilateral thyroid surgery as required by the guidelines
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
bo wang, md, 13705947900, wangbo@fjmu.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Thyroid Cancer, Recurrent Laryngeal Nerve Injuries
- Being tested
- Reversed Tracking Method
- Keywords
- external branches of superior laryngeal nerve, thyroidectomy, thyroid cancer
- Medical subject headings
- Thyroid Neoplasms, Recurrent Laryngeal Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reversed Tracking MethodProcedure or surgery
Reversed Tracking Method
| Study group | Role | What they receive |
|---|---|---|
| Standard method | No intervention | Standard method recommended by the guide |
| Reversed Tracking Method | Experimental | Reversed Tracking Method Receives: Procedure: Reversed Tracking Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
The identification rate of the external branch of the superior laryngeal nerve.
The identification rate of the external branch of the superior laryngeal nerve.
Measured: up to 6 months postoperatively
Secondary outcomes (6)
Friedman classification
Anatomical variability of the external branch of the superior laryngeal nerve according to Friedman classification.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start1 Oct 2018
- Primary completion30 Sep 2019 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Different methods of protection of external branches of superior laryngeal nerve
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Wang,MD, Fujian Medical University
- Investigators
- wenxin zhao, md, Study chair, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680222
- Sponsor's protocol ID
- IONM diffusion for EBSLN
- Status last verified
- Nov 2018
- First submitted
- 9 Sep 2018
- Last updated
- 9 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Reversed Tracking Method of Stimulating Cricothyroid Muscles on the Identification and Protection of EBSLN in Thyroid Surgery
- ClinicalTrials.gov ID
- NCT03680222
- Acronym / sponsor ID
- IONM diffusion for EBSLN
- Conditions
- Thyroid Cancer, Recurrent Laryngeal Nerve Injuries
- Keywords
- external branches of superior laryngeal nerve, thyroidectomy, thyroid cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 21 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Different methods of protection of external branches of superior laryngeal nerve
| Arm | Type | Receives |
|---|---|---|
| Standard method | No intervention | –Standard method recommended by the guide |
| Reversed Tracking Method | Experimental | Procedure: Reversed Tracking MethodReversed Tracking Method |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- thyroid papillary cancer patients
- thyroid adenoma patients
- tumor diameter less than 4cm
- patients who require only unilateral thyroid surgery as required by the guidelines
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reversed Tracking MethodReversed Tracking Method | Procedure or surgery | Reversed Tracking Method |
Primary outcome
The identification rate of the external branch of the superior laryngeal nerve.
Time frame: up to 6 months postoperatively
The identification rate of the external branch of the superior laryngeal nerve.
6 secondary outcomes
Friedman classification
Time frame: up to 6 months postoperatively
videostrobolaryngoscopy
Time frame: up to 6 months postoperatively
analysis of maximum phonation time (MPT)
Time frame: up to 6 months postoperatively
voice level (VL)
Time frame: up to 6 months postoperatively
fundamental frequency (Fo)
Time frame: up to 6 months postoperatively
voice quality rating on GRBAS scale
Time frame: up to 6 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
wenxin zhao, md study chair
Fujian Medical University Union Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reversed Tracking Method in people with Thyroid Cancer and Recurrent Laryngeal Nerve Injuries, run by Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bo Wang, md (13705947900, wangbo@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The identification rate of the external branch of the superior laryngeal nerve. (time frame: up to 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2018.