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NCT Number: NCT06791005

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

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.

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Key information

Conditions

Papillary Thyroid Cancer Adenocarcinoma Adenocarcinoma, Papillary Carcinoma Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Thyroid Cancer, Papillary Thyroid Diseases Thyroid Neoplasms

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710000, China

Location status: Recruiting

Location contact

Yang Liu, doctor

CONTACT

[email protected]

0086+029-13384986500

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Preoperative Injection of Carbon Nanoparticles

Drug

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

Drug

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.

Primary outcomes

  1. age

    Time frame: up to three years

    Age will be aggregated using "years" as the unit of measurement.

  2. Genders

    Time frame: up to three years

    Data will be summarized in terms of "male" and "female" as units of measurement.

  3. Height

    Time frame: up to three years

    The height indicator will summarize the data in "meters".

  4. Weight

    Time frame: up to three years

    The weight indicator will summarize data in "kilograms".

  5. BMI

    Time frame: up to three years

    BMI will be summarized in "kg/m^2".

  6. Tumor Diameter Size

    Time frame: up to three years

    Tumor diameter size will be summarized in "millimeters".

  7. Tumor Location

    Time frame: up to three years

    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.

  8. Pathological Results

    Time frame: up to three years

    Data will be summarized in terms of detailed pathological results and "none" .

  9. Preoperative Serum Calcium

    Time frame: up to three years

    The Calcium indicator will summarize data in "mmol/L".

  10. Preoperative Serum Thyroid Hormone

    Time frame: up to three years

    The thyroid hormone indicator will summarize data in "pmol/L".

  11. Preoperative Serum Parathyroid Hormone

    Time frame: up to three years

    The parathyroid hormone will summarize data in "pmol/L".

  12. Preoperative serum TSH

    Time frame: up to three years

    The TSH indicator will summarize data in "mlU/L".

  13. Preoperative Vocal Cord Movement Problems or Laryngoscopy Result

    Time frame: up to three years

    Data will be summarized in terms of "normal" , "symptomatic" and "laryngoscopy abnormal" as units of measurement.

  14. Carbon Nanoparticles Injection Site

    Time frame: up to three years

    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.

  15. Number of Carbon Nanoparticles Injections

    Time frame: up to three years

    Number of Carbon Nanoparticles Injections

  16. Carbon Nanoparticles Injection Dose

    Time frame: up to three years

    Injection dose will be summarized in "milliliter".

  17. Duration of The Operation

    Time frame: up to three years

    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

  18. Number of Lymph Node Dissection

    Time frame: up to three years

    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.

  19. Intraoperative Hemorrhage

    Time frame: up to three years

    The intraoperative hemorrhage will summarize data in "milliliter".

  20. Thyroid Staining

    Time frame: up to three years

    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;

  21. Lymph node staining

    Time frame: up to three years

    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.

  22. Parathyroid Glands Staining

    Time frame: up to three years

    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.

  23. Nanocarbon Leakage

    Time frame: up to three years

    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.

  24. Duration of Postoperative Pain

    Time frame: up to three years

    The duration of postoperative pain will summarize data in "days".

  25. Postoperative Drainage

    Time frame: up to three years

    The postoperative drainage will summarize data in "milliliter".

  26. Length of Postoperative Hospitalization

    Time frame: up to three years

    The length of postoperative hospitalization will summarize data in "days"

  27. Postoperative Serum Parathyroid Hormone

    Time frame: up to three years

    The parathyroid hormone will summarize data in "pmol/L".

  28. Numbness of The Hands and Feet

    Time frame: up to three years

    The numbness of the hands and feet will be summarized with a "yes" or "no" to the data.

  29. Postoperative Laryngeal Recurrent Nerve Irritation and Injury

    Time frame: up to three years

    Postoperative laryngeal recurrent nerve irritation and injury will be summarized with a "yes" or "no" to the data.

  30. Postoperative Hematoma

    Time frame: up to three years

    The postoperative hematoma will be summarized with a "yes" or "no" to the data.

  31. Postoperative Tracheocutaneous Fistula

    Time frame: up to three years

    The postoperative tracheocutaneous fistula will be summarized with a "yes" or "no" to the data.

Study contacts

Contact information is provided by the study sponsor or research team.

Yang Liu, doctor

CONTACT

[email protected]

0086+029-13384986500

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Xi'an Jiaotong University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 24, 2025
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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