Hydrodissection Tunneling Technique on Recurrent Laryngeal Nerve Protection During Thyroidectomy
NCT07298616 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 238
Last updated 2026-05-13
Summary
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.
Conditions
- Patients Undergoing Open Thyroid Surgery
Interventions
- PROCEDURE
-
Hydrodissection tunneling 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.
Sponsors & Collaborators
-
West China Tianfu Hospital
collaborator OTHER -
Shang Jin Hospital of West China Hospital,Sichuan University
collaborator UNKNOWN -
Sun Yat-Sen University Cancer Center
collaborator OTHER -
Sichuan Provincial People's Hospital
collaborator OTHER -
Sanya People's Hospital
collaborator UNKNOWN -
West China Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-01
- Primary Completion
- 2026-01-01
- Completion
- 2026-03-01
Countries
- China
Study Locations
More Related Trials
-
Neural Monitoring of the Superior Laryngeal Nerve in Thyroid Surgery
NCT02395146 ·Status: COMPLETED ·Phase: NA
-
Comparison of Intr-operative Neuromonitoring Technique in Trans-oral Endoscopic Thyroidectomy Vestibular Approach
NCT06801444 ·Status: RECRUITING
-
Renovated Prediction Model for Difficult Transoral and Submental Endoscopic Thyroidectomy
NCT06738888 ·Status: RECRUITING
-
Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerve Versus Neurostimulation
NCT01163045 ·Status: COMPLETED ·Phase: PHASE2
-
Effectiveness of Intraoperative Neuromonitoring of External Branch of Superior Laryngeal Nerve During Thyroid Surgery
NCT03773120 ·Status: TERMINATED ·Phase: NA
-
Comparison of the Vocal Cord Imaging Techniques After Thyroidectomy
NCT02410928 ·Status: COMPLETED ·Phase: NA
-
Hydrodissection of Recurrent Laryngeal Nerve: Case Series
NCT03907761 ·Status: COMPLETED
-
Predisection Risk Factors for Vocal Cord Palsy After Total Thyroid Surgery
NCT04986592 ·Status: COMPLETED
-
Low-dose Rocuronium Effect Neural Monitoring in Thyroid Surgery
NCT04230915 ·Status: UNKNOWN ·Phase: NA
-
Comparison of TOETVA and Conventional Thyroidectomy
NCT04647006 ·Status: COMPLETED ·Phase: NA
-
Effect of Intraoperative Nerve Monitoring on Voice Quality During Thyroid Surgery
NCT02509715 ·Status: UNKNOWN ·Phase: NA
-
Function Integrity of Neck Anatomy in Thyroid Surgery
NCT04666103 ·Status: RECRUITING ·Phase: NA
-
The Feasibility and Safety of the TOETVA for Benign Thyroid Nodules
NCT03158961 ·Status: COMPLETED ·Phase: NA
-
A Follow-up Study on Total Endoscopic Thyroidectomy Bilateral Areola Approach
NCT05315219 ·Status: COMPLETED ·Phase: NA
-
New Intraoperative Nerve Monitoring Device
NCT07071571 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Comparative Study Between Transcutaneous Ultrasonography and Direct Laryngoscopy for Assessment of Vocal Cord Mobility at the End of Thyroidectomy Operation
NCT06951295 ·Status: COMPLETED ·Phase: NA
-
Comparing the Therapeutic Efficacy of Extended Isthmusectomy Versus Total Thyroidectomy for Isthmus Tumors of the Thyroid
NCT07274605 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Comparative Study in Oral, Breast Approach and Open Thyroidectomy
NCT03479801 ·Status: UNKNOWN
-
Endoscopic Thyroidectomy Versus Open Thyroidectomy for Papillary Thyroid Carcinoma
NCT05446441 ·Status: UNKNOWN ·Phase: NA
-
NerveTrend vs. NerveAssure in Prevention of Recurrent Laryngeal Nerve Injury During Thyroid Surgery
NCT06289309 ·Status: RECRUITING ·Phase: NA
-
Post-thyroidectomy Vocal Cord Paralysis Along With Hypocalcemia: STROBE - Guided Prospective Cohort
NCT04396912 ·Status: UNKNOWN
-
The No-Tie Technique Using the Harmonic Scalpel in Total Thyroidectomy With Central Neck Dissection: A Prospective Randomized Study
NCT00506103 ·Status: COMPLETED
-
Improvements in Thyroid Tumor Surgery and the Prognosis, Diagnosis, Recurrence and Metastasis of Patients
NCT06468696 ·Status: RECRUITING ·Phase: NA
-
Effect of Anti-adhesion Barrier on the Voice Quality After Thyroidectomy.
NCT04853680 ·Status: UNKNOWN ·Phase: NA
-
Mecobalamin in Promoting Recurrent Laryngeal Nerve Function Recovery After Thyroid Surgery
NCT07274696 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3