Updated May 2026 · ClinicalTrials.gov
Huaxi Tunnel Technique For Recurrent Laryngeal Nerve Exposure And Dissection In Thyroid Surgery
The Efficacy and Safety of the Huaxi Tunnel Technique for Exposure and Dissection of the Recurrent Laryngeal Nerve in Thyroid Surgery：A Prospective, Single-Blind, Randomized Controlled Clinical Study
Huaxi Tunnel Technique For Recurrent Laryngeal Nerve Exposure And Dissection In Thyroid Surgery (NCT07298616) is a Phase 3 interventional studying Patients Undergoing Open Thyroid Surgery, sponsored by West China Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.
About This Trial
Protection of the recurrent laryngeal nerve (RLN) is a key focus and difficulty in thyroid surgery. Unilateral RLN injury can lead to ipsilateral vocal cord paralysis, resulting in hoarseness in patients postoperatively. Bilateral RLN injury, however, may cause bilateral vocal cord paralysis, leading to dyspnea and even asphyxiation; in severe cases, tracheotomy and permanent tracheal cannulation are required. Consequently, RLN injury significantly impacts patients' postoperative quality of life and career development. Guidelines and consensuses both domestically and internationally recommend that during the management of the posterior thyroid capsule, active detection, exposure, and dissection of the RLN, combined with meticulous capsular dissection along the RLN, should be performed to effectively reduce the incidence of RLN injury. While active anatomical identification of the RLN can clarify the nerve branches and their relationship with surrounding tissues, facilitating surgical procedures such as ligation and hemostasis, the traditional method of dissecting with instruments like hemostats or right-angle forceps (either blunt or sharp dissection along the nerve surface) increases the risk of nerve injury due to traction, clamping, or thermal damage. This is particularly challenging for less experienced surgeons, who face great difficulties in using energy devices near the RLN without causing injury-a major concern in the field of thyroid surgery. Diluted epinephrine solution exhibits excellent hemostatic effects in local surgery, improves surgical field clarity, and shortens operation time. Its safety has been clinically verified, and it is commonly used in plastic and cosmetic surgery, joint surgery, and the cavity creation process of endoscopic thyroid surgery. Based on this, this study innovatively proposes the "Huaxi Tunnel Technique": on the basis of meticulous posterior capsular dissection in traditional thyroid surgery, the RLN detection point on the posterior capsule below the lower pole of the thyroid is located using the "cross method" and exposed. A syringe containing diluted epinephrine solution is then used, with its front hose inserted along the RLN towards the laryngeal entry direction. Rapid injection is performed, and the pressure generated by this injection separates the fibrous connective tissue on the RLN surface, forming a "tunnel" from the RLN detection point to the laryngeal entry site-thus achieving exposure and dissection of the RLN. This technique offers multiple advantages: epinephrine reduces local bleeding, enhancing surgical safety and the convenience of meticulous capsular dissection; tunnel formation causes edema and discoloration of the fibrous connective tissue in the posterior thyroid capsule (while the parathyroid glands remain uncolored), facilitating the rapid identification and protection of the parathyroid glands. Preliminary preclinical experiments have confirmed that the technique reduces the difficulty of RLN exposure and dissection, decreases intraoperative bleeding and complication rates, and improves the safety of thyroid surgery. To further evaluate the efficacy, safety, and operability of this tunnel technique for RLN exposure and dissection, a prospective single-blind randomized controlled trial comparing it with traditional thyroid surgery methods is hereby conducted.
What Stage of Research Is This?
Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Patients Undergoing Open Thyroid Surgery, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.
This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.
A target enrollment of 700 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.
Who May Be Eligible (Plain English)
These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.
Original Eligibility Criteria
View original clinical language
Treatments Being Tested
Huaxi Tunnel Technique
A 5-ml syringe was loaded with adrenaline solution diluted in normal saline (1 mg adrenaline in 250 ml saline, concentration 4 µg/ml) and fitted with a 2-3 cm soft extension tube as the injection tip. After the recurrent laryngeal nerve (RLN) was identified by the cross-hatch method at the posteroinferior capsule below the lower pole of the thyroid gland, the solution was rapidly injected along the RLN's course toward its laryngeal entry point. The hydraulic pressure created by this rapid injection separated the fibrous connective tissue surrounding the nerve, forming a tissue tunnel from the initial identification site to the laryngeal entry point. Subsequent nerve dissection was then performed within this tunnel.
Locations (1)
Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.
How to Talk to Your Doctor About This Trial
Bring the printable summary of this trial — including the NCT ID (NCT07298616), the sponsor (West China Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.
Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.
Authoritative Sources
The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.
Frequently Asked Questions
What is the NCT07298616 clinical trial studying?
Protection of the recurrent laryngeal nerve (RLN) is a key focus and difficulty in thyroid surgery. Unilateral RLN injury can lead to ipsilateral vocal cord paralysis, resulting in hoarseness in patients postoperatively. Bilateral RLN injury, however, may cause bilateral vocal cord paralysis, leading to dyspnea and even asphyxiation; in severe cases, tracheotomy and permanent tracheal cannulation are required. Consequently, RLN injury significantly impacts patients' postoperative quality of life and career development. Guidelines and consensuses both domestically and internationally recommend … The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.
Who can participate in NCT07298616?
Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.
How do I contact the trial site for NCT07298616?
Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.
Is participating in a clinical trial safe?
Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.
Where can I verify the data on this page?
Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.
How This Page Is Built
Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.
Source: ClinicalTrials.gov API v2 record for NCT07298616. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07298616. Data: ClinicalTrials.gov."
Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.
Last updated 2026-05-08 · Data from ClinicalTrials.gov.