RecruitingPhase 3NCT06791005

A Clinical Study on the Benefits of Carbon Nanoparticles Injection Time in Patients With Thyroid Cancer.

A Comparative Study of Preoperative and Intraoperative Carbon Nanoparticles Injection in Patients Undergoing Thyroid Cancer Surgery

Sponsor

Second Affiliated Hospital of Xi'an Jiaotong University

Enrollment

400 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Papillary Thyroid Cancer

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.

Eligibility

Min Age: 16 YearsMax Age: 80 Years

Inclusion Criteria6

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 Criteria8

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.

Interventions

DRUGPreoperative Injection of Carbon Nanoparticles

1.Medication: 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. 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.

DRUGIntraoperative Injection of Carbon Nanoparticles

Intraoperative injection of carbon nanoparticles: After exposing the thyroid peritoneum, 0.1 mL of carbon nanoparticles was injected into both sides of normal thyroid tissue using a syringe (1 mL). Two spots were needed for each flap, and the total volume of injected carbon nanoparticles was 0.4 mL. Finally, the needle was gently backed up under negative pressure to prevent the leakage of carbon nanoparticles.