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

NCT ID: NCT06791005

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-09-30

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.

Conditions

Papillary Thyroid Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Preoperative Injection Before Partial Thyroidectomy Group

Patients in this group will undergo partial thyroidectomy and preoperative injection of carbon nanoparticles.

Group Type: EXPERIMENTAL

Preoperative Injection of Carbon Nanoparticles

Intervention Type: 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 During Partial Thyroidectomy Group

Patients in this group will undergo partial thyroidectomy and intraoperative injection of carbon nanoparticles.

Group Type: ACTIVE_COMPARATOR

Intraoperative Injection of Carbon Nanoparticles

Intervention Type: 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.

Preoperative Injection Before Total Thyroidectomy Group

Patients in this group will undergo total thyroidectomy and preoperative injection of carbon nanoparticles.

Group Type: EXPERIMENTAL

Preoperative Injection of Carbon Nanoparticles

Intervention Type: 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 During Total Thyroidectomy Group

Patients in this group will undergo total thyroidectomy and intraoperative injection of carbon nanoparticles.

Group Type: ACTIVE_COMPARATOR

Intraoperative Injection of Carbon Nanoparticles

Intervention Type: 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.

Interventions

Preoperative 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.

Intervention Type: DRUG

Intraoperative 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yang Liu, doctor

Role: CONTACT

individualliu@163.com

0086+029-13384986500

Facility Contacts

Yang Liu, doctor

Role: primary

individualliu@163.com

0086+029-13384986500

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

nanoc

Identifier Type: -

Identifier Source: org_study_id