Benefits of Carbon Nanoparticles Injection Timing in Thyroid Cancer Treatment
A Comparative Study of Preoperative and Intraoperative Carbon Nanoparticles Injection in Patients Undergoing Thyroid Cancer Surgery
PHASE3 · Second Affiliated Hospital of Xi'an Jiaotong University · NCT06791005
This study tests whether giving carbon nanoparticles before or during surgery can help people with papillary thyroid cancer have better outcomes and fewer complications.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 16 Years to 80 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital of Xi'an Jiaotong University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT06791005 on ClinicalTrials.gov |
What this trial studies
This clinical study investigates the timing of carbon nanoparticles injection in patients undergoing surgery for papillary thyroid cancer. Participants will receive injections either preoperatively or intraoperatively to assess the impact on surgical outcomes and complications. The study aims to minimize common postoperative complications such as hypoparathyroidism and recurrent laryngeal nerve injury. By utilizing ultrasound guidance for precise injection, the research seeks to improve the safety and effectiveness of thyroid cancer surgeries.
Who should consider this trial
Good fit: Ideal candidates are adults with a confirmed diagnosis of papillary thyroid cancer, requiring total thyroidectomy, and with tumors less than 4 cm in diameter.
Not a fit: Patients with a history of prior thyroid surgery, those under 16 years of age, or individuals with certain tumor characteristics may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative complications and improve the quality of life for patients with thyroid cancer.
How similar studies have performed: While the use of carbon nanoparticles in surgical settings is emerging, this specific approach to timing and application in thyroid cancer treatment is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Xi'an, Shaanxi
- The Second Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (RECRUITING)
Study contacts
- Study coordinator: Yang Liu, doctor
- Email: individualliu@163.com
- Phone: 0086+029-13384986500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Papillary Thyroid Cancer, thyroid surgery, developer, complication