Study Comparing Preoperative and Intraoperative Carbon Nanoparticle Injections in Thyroid Cancer Surgery Patients

What this Trial Is About

Researchers are investigating the timing of carbon nanoparticle injections in patients undergoing surgery for papillary thyroid cancer. The study aims to compare the benefits of preoperative versus intraoperative injection of carbon nanoparticles to improve the detection of parathyroid glands and lymph node clearance, while minimizing complications like hypoparathyroidism and nerve injury. This phase 3 trial involves over 400 patients and seeks to establish standardized guidelines for injection dose, timing, and method. Participants are divided into four groups based on whether they receive partial or total thyroidectomy and whether carbon nanoparticles are injected preoperatively or intraoperatively. The preoperative injection involves ultrasound-guided fine needle puncture 2 to 6 hours before surgery, delivering a total of 0.4 mL carbon nanoparticles at specific thyroid gland sites. The intraoperative injection is administered after thyroid exposure during surgery with the same total dose and injection technique to reduce leakage. Throughout the study, researchers will collect detailed data including patient demographics, tumor characteristics, biochemical markers, and surgical outcomes. They will monitor intraoperative conditions such as lymph node and parathyroid staining, nanocarbon leakage, operation duration, and bleeding. Postoperative assessments include pain duration, drainage, hospitalization length, calcium and hormone levels, nerve function, and complications like hematoma or fistula. Data will be collected for up to three years to evaluate the impact of injection timing on surgical success and patient quality of life.

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