Thyroid DiseaseNCT07706699
Low-Current Stimulation for Recurrent Laryngeal Nerve Protection During Thyroid Surgery
A study testing 3 mA low-current stimulation-assisted recurrent laryngeal nerve identification and 5 mA low-current stimulation-assisted recurrent laryngeal nerve identification in people with Thyroid Disease and Recurrent Laryngeal Nerve Injury, run by The Second Affiliated Hospital of Kunming Medical University at 1 site in China.
Trial summary
This single-center prospective randomized interventional study evaluated whether intraoperative low-current stimulation could assist recurrent laryngeal nerve localization and reduce temporary recurrent laryngeal nerve injury during thyroid surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Disease, Recurrent Laryngeal Nerve Injury
- What is being tested?
- 3 mA low-current stimulation-assisted recurrent laryngeal nerve identification and 5 mA low-current stimulation-assisted recurrent laryngeal nerve identification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 1 Mar 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for thyroid surgery.
- No history of prior thyroid or neck surgery.
- Normal bilateral vocal cord mobility on preoperative electronic laryngoscopy.
- Written informed consent provided before enrollment.
Who cannot join
- Preoperative recurrent laryngeal nerve dysfunction.
- Previous neck surgery.
- Incomplete clinical data.
- Severe comorbidities precluding standardized perioperative assessment.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650000
About this study
Official title: Clinical Utility of Low-Current Stimulation for Recurrent Laryngeal Nerve Protection During Thyroid Surgery: A Single-Center Prospective Randomized Interventional Study
This single-center prospective randomized interventional study evaluated whether intraoperative low-current stimulation could assist recurrent laryngeal nerve localization and reduce temporary recurrent laryngeal nerve injury during thyroid surgery.
Read the detailed description
A total of 150 patients undergoing thyroid surgery at the Second Affiliated Hospital of Kunming Medical University were randomly allocated in a 1:1:1 ratio to conventional anatomical identification, 3 mA low-current stimulation, or 5 mA low-current stimulation. All participants underwent preoperative and postoperative electronic laryngoscopy. The primary outcome was temporary recurrent laryngeal nerve injury. Secondary outcomes included permanent recurrent laryngeal nerve injury, operative duration, intraoperative blood loss, postoperative hospital stay, and stimulation-related adverse events.
- Conditions
- Thyroid Disease, Recurrent Laryngeal Nerve Injury
- Being tested
- 3 mA low-current stimulation-assisted recurrent laryngeal nerve identification, 5 mA low-current stimulation-assisted recurrent laryngeal nerve identification
- Keywords
- Recurrent laryngeal nerve, Low-current stimulation, Thyroidectomy, Intraoperative nerve identification
- Medical subject headings
- Thyroid Diseases, Recurrent Laryngeal Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 mA low-current stimulation-assisted recurrent laryngeal nerve identificationProcedure or surgery
Low-current stimulation at 3 mA was used as an adjunct to anatomical recurrent laryngeal nerve identification. Response was judged according to visible or palpable laryngeal twitch.
5 mA low-current stimulation-assisted recurrent laryngeal nerve identificationProcedure or surgery
Low-current stimulation at 5 mA was used as an adjunct to anatomical recurrent laryngeal nerve identification. Response was judged according to visible or palpable laryngeal twitch.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Participants underwent conventional anatomical identification and preservation of the recurrent laryngeal nerve during thyroid surgery. |
| 3 mA group | Experimental | Participants underwent 3 mA low-current stimulation-assisted recurrent laryngeal nerve identification in addition to conventional anatomical identification. Receives: Procedure: 3 mA low-current stimulation-assisted recurrent laryngeal nerve identification |
| 5 mA group | Experimental | Participants underwent 5 mA low-current stimulation-assisted recurrent laryngeal nerve identification in addition to conventional anatomical identification. Receives: Procedure: 5 mA low-current stimulation-assisted recurrent laryngeal nerve identification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Permanent Recurrent Laryngeal Nerve Injury Confirmed by Electronic Laryngoscopy
Permanent recurrent laryngeal nerve injury is defined as unilateral or bilateral vocal cord paresis or paralysis detected after surgery and still present at the 6-month postoperative assessment, as confirmed by electronic laryngoscopy. The number of participants meeting this definition will be reported.
Measured: 6 months after surgery
Secondary outcomes (5)
Number of Participants With Vocal Cord Paresis or Paralysis Persisting at 6 Months, as Assessed by Electronic Laryngoscopy
Permanent recurrent laryngeal nerve injury is defined as unilateral or bilateral vocal cord paresis or paralysis detected after surgery and still present at the 6-month postoperative assessment, as confirmed by electronic laryngoscopy. The number of participants meeting this definition will be reported.
Measured: 6 months after surgery
Total Operative Duration in Minutes
Total operative duration will be measured in minutes from the initial skin incision to completion of skin closure.
Measured: Intraoperative period
Intraoperative blood loss
Estimated intraoperative blood loss measured in milliliters.
Measured: Intraoperative period
Duration of Postoperative Hospital Stay in Days
Postoperative hospital stay will be calculated as the number of calendar days from the date of surgery to the date of hospital discharge.
Measured: From the date of surgery until hospital discharge, assessed up to 30 days after surgery
Number of Participants With Stimulation-Related Adverse Events
The number of participants experiencing at least one stimulation-related adverse event will be reported. Stimulation-related adverse events include suspected thermal injury, arrhythmia, hemodynamic instability, muscle burn, overstimulation, or suspected false-negative nerve localization, as documented in the intraoperative and postoperative medical records.
Measured: From initiation of intraoperative nerve stimulation through 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Jun 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DiseaseStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized to one of three parallel groups: conventional anatomical identification, 3 mA low-current stimulation-assisted identification, or 5 mA low-current stimulation-assisted identification.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Kunming Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siqi Li, The Second Affiliated Hospital of Kunming Medical University
- Investigators
- Siqi Li, Principal investigator, The Second Affiliated Hospital of Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706699
- Sponsor's protocol ID
- RLN-LCS-2024-001
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of Low-Current Stimulation for Recurrent Laryngeal Nerve Protection During Thyroid Surgery: A Single-Center Prospective Randomized Interventional Study
- ClinicalTrials.gov ID
- NCT07706699
- Acronym / sponsor ID
- RLN-LCS-2024-001
- Conditions
- Thyroid Disease, Recurrent Laryngeal Nerve Injury
- Keywords
- Recurrent laryngeal nerve, Low-current stimulation, Thyroidectomy, Intraoperative nerve identification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The Second Affiliated Hospital of Kunming Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 16 Jul 2026 (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.
This single-center prospective randomized interventional study evaluated whether intraoperative low-current stimulation could assist recurrent laryngeal nerve localization and reduce temporary recurrent laryngeal nerve injury during thyroid surgery.
Detailed description
A total of 150 patients undergoing thyroid surgery at the Second Affiliated Hospital of Kunming Medical University were randomly allocated in a 1:1:1 ratio to conventional anatomical identification, 3 mA low-current stimulation, or 5 mA low-current stimulation. All participants underwent preoperative and postoperative electronic laryngoscopy. The primary outcome was temporary recurrent laryngeal nerve injury. Secondary outcomes included permanent recurrent laryngeal nerve injury, operative duration, intraoperative blood loss, postoperative hospital stay, and stimulation-related adverse events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants were randomized to one of three parallel groups: conventional anatomical identification, 3 mA low-current stimulation-assisted identification, or 5 mA low-current stimulation-assisted identification.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Participants underwent conventional anatomical identification and preservation of the recurrent laryngeal nerve during thyroid surgery. |
| 3 mA group | Experimental | Procedure: 3 mA low-current stimulation-assisted recurrent laryngeal nerve identificationParticipants underwent 3 mA low-current stimulation-assisted recurrent laryngeal nerve identification in addition to conventional anatomical identification. |
| 5 mA group | Experimental | Procedure: 5 mA low-current stimulation-assisted recurrent laryngeal nerve identificationParticipants underwent 5 mA low-current stimulation-assisted recurrent laryngeal nerve identification in addition to conventional anatomical identification. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for thyroid surgery.
- No history of prior thyroid or neck surgery.
- Normal bilateral vocal cord mobility on preoperative electronic laryngoscopy.
- Written informed consent provided before enrollment.
Key exclusion criteria (4 listed)
- Preoperative recurrent laryngeal nerve dysfunction.
- Previous neck surgery.
- Incomplete clinical data.
- Severe comorbidities precluding standardized perioperative assessment.
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 |
|---|---|---|
| 3 mA low-current stimulation-assisted recurrent laryngeal nerve identificationLow-current stimulation at 3 mA was used as an adjunct to anatomical recurrent laryngeal nerve identification. Response was judged according to visible or palpable laryngeal twitch. | Procedure or surgery | 3 mA group |
| 5 mA low-current stimulation-assisted recurrent laryngeal nerve identificationLow-current stimulation at 5 mA was used as an adjunct to anatomical recurrent laryngeal nerve identification. Response was judged according to visible or palpable laryngeal twitch. | Procedure or surgery | 5 mA group |
Primary outcome
Number of Participants With Permanent Recurrent Laryngeal Nerve Injury Confirmed by Electronic Laryngoscopy
Time frame: 6 months after surgery
Permanent recurrent laryngeal nerve injury is defined as unilateral or bilateral vocal cord paresis or paralysis detected after surgery and still present at the 6-month postoperative assessment, as confirmed by electronic laryngoscopy. The number of participants meeting this definition will be reported.
5 secondary outcomes
Number of Participants With Vocal Cord Paresis or Paralysis Persisting at 6 Months, as Assessed by Electronic Laryngoscopy
Time frame: 6 months after surgery
Total Operative Duration in Minutes
Time frame: Intraoperative period
Intraoperative blood loss
Time frame: Intraoperative period
Duration of Postoperative Hospital Stay in Days
Time frame: From the date of surgery until hospital discharge, assessed up to 30 days after surgery
Number of Participants With Stimulation-Related Adverse Events
Time frame: From initiation of intraoperative nerve stimulation through 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Thyroid Disease
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingObservational study
Clinical and Basic Investigations Into Known and Suspected Congenital Disorders of Glycosylation
Congenital Disorders of Glycosylation
RecruitingObservational study
Studies on Tumors of the Thyroid
Hurthle Cell Thyroid Cancer, Tall Cell Variant Thyroid Cancer
RecruitingObservational study
DICER1-related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study
Pleuropulmonary Blastoma, Cystic Nephroma
RecruitingPhase 2
The Use of 124-I-PET/CT Whole Body and Lesional Dosimetry in Differentiated Thyroid Cancer
Thyroid Cancer
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.
Siqi Li principal investigator
The Second Affiliated Hospital of Kunming Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 mA low-current stimulation-assisted recurrent laryngeal nerve identification and 5 mA low-current stimulation-assisted recurrent laryngeal nerve identification in people with Thyroid Disease and Recurrent Laryngeal Nerve Injury, run by The Second Affiliated Hospital of Kunming 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 4 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: finished, as of the sponsor's last update on 16 Jul 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Permanent Recurrent Laryngeal Nerve Injury Confirmed by Electronic Laryngoscopy (time frame: 6 months after surgery). 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 16 Jul 2026.