Actively Recruiting
A Comparative Study of Preoperative and Intraoperative Carbon Nanoparticles Injection in Patients Undergoing Thyroid Cancer Surgery
Led by Second Affiliated Hospital of Xi'an Jiaotong University · Updated on 2025-01-24
400
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
A Clinical Study on the Benefits of Carbon Nanoparticles Injection Time in Patients With Thyroid Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 to 6 hours
Participants receive a preoperative injection of carbon nanoparticles 2 to 6 hours before surgery under ultrasound guidance.
1 visit (in-person)
Duration - Duration of the surgery and immediate recovery
Participants undergo partial or total thyroidectomy with either intraoperative or preoperative carbon nanoparticles injection as per group assignment.
1 visit (in-person)
Duration - Up to 3 years
Participants are monitored for post-surgical outcomes including pain, drainage, hospital stay length, and potential complications.
Multiple visits over 3 years
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710000
Actively Recruiting
Research Team
Y
Yang Liu, doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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