Clinical trial NCT06791005: A Clinical Study on the Benefits of Carbon Nanoparticles Injection Time in Patients With Thyroid Cancer.
Official title: A Comparative Study of Preoperative and Intraoperative Carbon Nanoparticles Injection in Patients Undergoing Thyroid Cancer Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Papillary Thyroid Cancer
Keywords: Papillary Thyroid Cancer
thyroid surgery
developer
complication
Lead sponsor: Second Affiliated Hospital of Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 400
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The detection rate of thyroid cancer (PTC) has increased rapidly in recent years. Except undifferentiated cancer, surgery is still one of the most important treatments for all types of thyroid cancer, and there is a consensus to use the lobes of the gland as the minimum extent of resection. In the meantime, a basic consensus has been reached that central zone lymph node (VI) dissection is the minimum extent of lymph node dissection. In clinical practice, neck surgery and lumpectomy are mostly performed. Hypoparathyroidism and recurrent laryngeal nerve injury are the most common complications of radical surgery for thyroid cancer, both in open surgery and the luminal approach. Once these complications occur, they have a serious impact on the quality of life of patients in the postoperative period. A number of contrast agents are now being used to help minimize complications. Carbon nanoparticles are an effective and non-harmful negative developer, and many studies have confirmed that carbon nanoparticles can be used to identify parathyroid glands in thyroid surgery. Intraoperative injection of nanocarbon is effective in increasing the quality of intraoperative parathyroid detection and lymph node clearance and reducing adverse effects, such as postoperative hypokalemia.However, there is no complete clinical guideline for preoperative intraglandular injection of carbon nanoparticles, and there is no standardized dosage for appropriate injection time, injection dose, and injection method. At the same time, there is still the problem of carbon nanoparticle leakage. At our medical center, we have found that preoperative injection of carbon nanoparticles via ultrasound-guided fine needle puncture may yield better results by reducing CNS exudation in the surgical area. In this study, we will collect more than 400 patients who underwent thyroidectomy in 2025 and underwent carbon nanoparticle injections at different time points and analyzed their intraoperative and postoperative conditions as a basis for analyzing the difference in patient benefits between preoperative and intraoperative carbon nanoparticle injections and to provide data to support the clinical use of carbon nanoparticles.

Detailed description: 1. Use of drugs: Carbon nanoparticles, Chongqing Lemay Pharmaceutical Co. Ltd., production license, Food and Drug Administration Production License No. (China) 2007204, Registration No.: State prescription H20041829. The product is a stable suspension of carbon particles with a diameter of 150 nm.2. Preoperative injection method: The preoperative subgroup was injected with carbon nanoparticles 2-6 hours before surgery, with the patient in the position of padded shoulder, and disinfection around the puncture point was prepared prior to the injection of carbon nanoparticles. Under ultrasound guidance, a fine needle was used to puncture the lower 1/3 of the ventral surface, and no blood was detected on aspiration, i.e., 0.1 mL of carbon nanoparticles was injected into each of the 2 sites of each gland, and the total volume of carbon nanoparticles injected was 0.4 mL, and the depth of injection was approximately within the upper third of the gland.

Eligibility criteria: Inclusion Criteria:

* Preoperative pathological assessment indicated the presence of thyroid cancer with a maximum diameter of less than 4 cm.
* Postoperative pathological evaluation confirmed bilateral thyroid cancer or lateral lymph node metastasis.
* Vocal cord examination conducted one week prior to surgery revealed no abnormalities.
* The patient had no history of prior thyroid surgery and required a total thyroidectomy.
* Blood pressure was stably controlled.
* The patient regained consciousness and was able to communicate normally.

Exclusion Criteria:

* Prior to enrollment, the patient had received radiotherapy, chemotherapy, or isotope therapy.
* A documented history of thyroid surgery.
* Age under 16 years.
* Known allergies to the medications under investigation or an inability to tolerate surgical intervention.
* Presence of a retrosternal thyroid tumor.
* Tumor invasion of the parathyroid glands and/or the recurrent laryngeal nerve during surgical procedures.
* Postoperative pathology suggestive of medullary carcinoma or undifferentiated carcinoma.
* Development of a postoperative tracheal fistula.

Primary outcomes:
measure: age
timeFrame: up to three years
measure: Genders
timeFrame: up to three years
measure: Height
timeFrame: up to three years
measure: Weight
timeFrame: up to three years
measure: BMI
timeFrame: up to three years
measure: Tumor Diameter Size
timeFrame: up to three years
measure: Tumor Location
timeFrame: up to three years
measure: Pathological Results
timeFrame: up to three years
measure: Preoperative Serum Calcium
timeFrame: up to three years
measure: Preoperative Serum Thyroid Hormone
timeFrame: up to three years
measure: Preoperative Serum Parathyroid Hormone
timeFrame: up to three years
measure: Preoperative serum TSH
timeFrame: up to three years
measure: Preoperative Vocal Cord Movement Problems or Laryngoscopy Result
timeFrame: up to three years
measure: Carbon Nanoparticles Injection Site
timeFrame: up to three years
measure: Number of Carbon Nanoparticles Injections
timeFrame: up to three years
measure: Carbon Nanoparticles Injection Dose
timeFrame: up to three years
measure: Duration of The Operation
timeFrame: up to three years
measure: Number of Lymph Node Dissection
timeFrame: up to three years
measure: Intraoperative Hemorrhage
timeFrame: up to three years
measure: Thyroid Staining
timeFrame: up to three years
measure: Lymph node staining
timeFrame: up to three years
measure: Parathyroid Glands Staining
timeFrame: up to three years
measure: Nanocarbon Leakage
timeFrame: up to three years
measure: Duration of Postoperative Pain
timeFrame: up to three years
measure: Postoperative Drainage
timeFrame: up to three years
measure: Length of Postoperative Hospitalization
timeFrame: up to three years
measure: Postoperative Serum Parathyroid Hormone
timeFrame: up to three years
measure: Numbness of The Hands and Feet
timeFrame: up to three years
measure: Postoperative Laryngeal Recurrent Nerve Irritation and Injury
timeFrame: up to three years
measure: Postoperative Hematoma
timeFrame: up to three years
measure: Postoperative Tracheocutaneous Fistula
timeFrame: up to three years
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
References: