Actively Recruiting

Phase 3
Age: 16Years - 80Years
All Genders
ID06791005

Comparing Preoperative and Intraoperative Carbon Nanoparticle 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

38 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the best timing for injecting carbon nanoparticles during thyroid cancer surgery to improve surgical outcomes. This study focuses on patients with papillary thyroid cancer undergoing thyroidectomy, comparing preoperative and intraoperative carbon nanoparticle injections. Carbon nanoparticles have been shown to help identify parathyroid glands and lymph nodes, potentially reducing common complications like hypoparathyroidism and nerve injury that affect patients' quality of life after surgery. However, standardized guidelines on the timing, dose, and injection methods are lacking, and this study aims to provide data to support clinical use. The study evaluates two approaches: injecting carbon nanoparticles 2 to 6 hours before surgery using ultrasound-guided fine needle puncture, and injecting them during surgery directly into normal thyroid tissue. In the preoperative group, 0.4 mL total is injected into two sites on each gland shortly before surgery. In the intraoperative group, the same dose is given into two sites on each thyroid lobe after exposing the thyroid during surgery. Both methods use careful injection techniques to minimize nanoparticle leakage. Participants will be monitored up to three years after surgery, with data collected on tumor size and location, hormone levels, vocal cord function, operation duration, lymph node removal, bleeding, and postoperative complications such as pain, nerve injury, and hospital stay length. Researchers will assess the effects of nanoparticle injection timing on surgical quality and patient outcomes to improve treatment for thyroid cancer. This is a phase 3 study including patients aged 16 to 80 years.

CONDITIONS

Official Title

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

Who Can Participate

Age: 16Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Preoperative pathology showed thyroid cancer with a tumor less than 4 cm in diameter
  • Postoperative pathology confirmed bilateral thyroid cancer or lateral lymph node metastasis
  • Vocal cord exam within one week before surgery showed no abnormalities
  • No history of thyroid surgery and need for total thyroidectomy
  • Blood pressure is stable
  • Patient is awake and able to communicate normally
Not Eligible

You will not qualify if you...

  • Prior radiotherapy, chemotherapy, or isotope therapy before enrollment
  • History of thyroid surgery
  • Age under 16 years
  • Allergies to study drugs or unable to tolerate surgery
  • Retrosternal thyroid tumor present
  • Tumor invading parathyroid glands or recurrent laryngeal nerve during surgery
  • Postoperative pathology shows medullary or undifferentiated carcinoma
  • Development of postoperative tracheal fistula

AI-Screening

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Trial Site Locations

Total: 1 location

1

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China, 710000

Actively Recruiting

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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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