NCT06791005RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 24 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 18 Jan 2025
- Start date
- 1 Jan 2025
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Diseases
- Thyroid cancer, Childhood cancers
- NCT number
- NCT06791005
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 400
- From 1 Jan 2025 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior to enrollment, the patient had received radiotherapy, chemotherapy, or isotope therapy.
- Tumor invasion of the parathyroid glands and/or the recurrent laryngeal nerve during surgical procedures.
Other illness
- A documented history of thyroid surgery.
- Known allergies to the medications under investigation or an inability to tolerate surgical intervention.
- Development of a postoperative tracheal fistula.
Age
- Age under 16 years.
Other
- Presence of a retrosternal thyroid tumor.
- Postoperative pathology suggestive of medullary carcinoma or undifferentiated carcinoma.
Who the study is looking for
- 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.
Age in the registry: 16 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.