A Phase 3 interventional study of Preoperative Injection of Carbon Nanoparticles and Intraoperative Injection of Carbon Nanoparticles in Papillary Thyroid Cancer, sponsored by Second Affiliated Hospital of Xi'an Jiaotong University. Recruiting at 1 site in China. Open to participants aged 16 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-01-24.
Sponsored by Second Affiliated Hospital of Xi'an Jiaotong University · Phase 3, Interventional, and Treatment
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.
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.
178 studies on the registry are indexed under Thyroid Cancer, Papillary; 54 are open to participants now.
This study's planned enrollment of 400 is above the median of 51 across 110 interventional studies indexed under Thyroid Cancer, Papillary.
Browse Thyroid Cancer, Papillary studies →Second Affiliated Hospital of Xi'an Jiaotong University is the lead sponsor of 70 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
Patients in this group will undergo partial thyroidectomy and preoperative injection of carbon nanoparticles.
Drug: Preoperative Injection of Carbon Nanoparticles
Patients in this group will undergo partial thyroidectomy and intraoperative injection of carbon nanoparticles.
Drug: Intraoperative Injection of Carbon Nanoparticles
Patients in this group will undergo total thyroidectomy and preoperative injection of carbon nanoparticles.
Drug: Preoperative Injection of Carbon Nanoparticles
Patients in this group will undergo total thyroidectomy and intraoperative injection of carbon nanoparticles.
Drug: Intraoperative 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.
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.
age
Age will be aggregated using "years" as the unit of measurement.
Time frame: up to three years
Genders
Data will be summarized in terms of "male" and "female" as units of measurement.
Time frame: up to three years
Height
The height indicator will summarize the data in "meters".
Time frame: up to three years
Weight
The weight indicator will summarize data in "kilograms".
Time frame: up to three years
BMI
BMI will be summarized in "kg/m\^2".
Time frame: up to three years
Tumor Diameter Size
Tumor diameter size will be summarized in "millimeters".
Time frame: up to three years
Tumor Location
Data will be summarized in terms of "Upper pole of left lobe" , "middle pole of left lobe" , "lower pole of left lobe" , "upper pole of right lobe" , "middle pole of right lobe" , "lower pole of right lobe" , "isthmus" and "multifocal" as units of measurement.
Time frame: up to three years
Pathological Results
Data will be summarized in terms of detailed pathological results and "none" .
Time frame: up to three years
Preoperative Serum Calcium
The Calcium indicator will summarize data in "mmol/L".
Time frame: up to three years
Preoperative Serum Thyroid Hormone
The thyroid hormone indicator will summarize data in "pmol/L".
Time frame: up to three years
Preoperative Serum Parathyroid Hormone
The parathyroid hormone will summarize data in "pmol/L".
Time frame: up to three years
Preoperative serum TSH
The TSH indicator will summarize data in "mlU/L".
Time frame: up to three years
Preoperative Vocal Cord Movement Problems or Laryngoscopy Result
Data will be summarized in terms of "normal" , "symptomatic" and "laryngoscopy abnormal" as units of measurement.
Time frame: up to three years
Carbon Nanoparticles Injection Site
Data will be summarized in terms of "Upper pole of left lobe" , "middle pole of left lobe" , "lower pole of left lobe" , "upper pole of right lobe" , "middle pole of right lobe" , "lower pole of right lobe" , "isthmus" and "multi-site injection" as units of measurement.
Time frame: up to three years
Number of Carbon Nanoparticles Injections
Number of Carbon Nanoparticles Injections
Time frame: up to three years
Carbon Nanoparticles Injection Dose
Injection dose will be summarized in "milliliter".
Time frame: up to three years
Duration of The Operation
The duration of the operation will summarize data in "h". The time interval from the induction of anesthesia to the end of surgery was selected as the length of surgery, according to the surgical care records
Time frame: up to three years
Number of Lymph Node Dissection
Record the total number of lymph nodes dissected, the number of lymph nodes dissected in the central region, the number of lymph nodes dissected in the lateral cervical region and the number of metastatic lymph nodes detected.
Time frame: up to three years
Intraoperative Hemorrhage
The intraoperative hemorrhage will summarize data in "milliliter".
Time frame: up to three years
Thyroid Staining
Data will be summarized in terms of "A" ,"B" and "C" as units of measurement. A.The stained thyroid is good in the center and at the margins, with clear staining at the edges; B.The stained thyroid gland has good central staining, and the margins are grossly stained, so that the marginal pattern can be roughly observed; C.The stained thyroid stains well, with poorly stained margins;
Time frame: up to three years
Lymph node staining
Data will be summarized in terms of "A" ,"B" and "C" as units of measurement. A.The center and margins of the stained lymph nodes are well stained, and the margins are clearly stained; B. The stained lymph nodes have good central staining and grossly stained margins; the marginal pattern can be roughly observed, and the lymph nodes are definite on palpation; C.Good central staining of the stained lymph nodes, unclear staining of the margins, and precise palpation of the lymph nodes.
Time frame: up to three years
Parathyroid Glands Staining
Data will be summarized in terms of "A" ,"B" and "C" as units of measurement. A.Good central infiltration, uniform and clear staining throughout the gland; B.Central infiltration is good, staining of the entire gland is still uniform, but flaky stained areas are seen, and the gland is exact on palpation; C.Central infiltration is fair, staining of the entire gland is stellate with no obvious shape, and the gland is exact on palpation.
Time frame: up to three years
Nanocarbon Leakage
Data will be summarized in terms of "A" ,"B" and "C" as units of measurement. A.no visible leakage, only slight leakage at the injection site, not affecting the parathyroid glands or the recurrent laryngeal nerve; B.leakage is present and visible to the naked eye, but less than 1/2 of the entire operative field, with staining of the trachea, thyroid peritoneum, and anterior cervical musculature; C.Leakage is present and reaches 1/2 of the entire operative field or Carbon Nanoparticles results in staining of the parathyroid glands or the recurrent laryngeal nerve, affecting identification.
Time frame: up to three years
Duration of Postoperative Pain
The duration of postoperative pain will summarize data in "days".
Time frame: up to three years
Postoperative Drainage
The postoperative drainage will summarize data in "milliliter".
Time frame: up to three years
Length of Postoperative Hospitalization
The length of postoperative hospitalization will summarize data in "days"
Time frame: up to three years
Postoperative Serum Parathyroid Hormone
The parathyroid hormone will summarize data in "pmol/L".
Time frame: up to three years
Numbness of The Hands and Feet
The numbness of the hands and feet will be summarized with a "yes" or "no" to the data.
Time frame: up to three years
Postoperative Laryngeal Recurrent Nerve Irritation and Injury
Postoperative laryngeal recurrent nerve irritation and injury will be summarized with a "yes" or "no" to the data.
Time frame: up to three years
Postoperative Hematoma
The postoperative hematoma will be summarized with a "yes" or "no" to the data.
Time frame: up to three years
Postoperative Tracheocutaneous Fistula
The postoperative tracheocutaneous fistula will be summarized with a "yes" or "no" to the data.
Time frame: up to three years
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Started Jan 2025 (actual). Primary completion is estimated for Jun 2025, 5 months after the start.
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Second Affiliated Hospital of Xi'an Jiaotong University