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A Multi-center, Randomized, Blank Parallel Controlled Clinical Study to Evaluate the Safety and Efficacy of Carbon Nanoparticles Suspension Injection in Surgical Treatment of Papillary Thyroid Carcinoma

A Multi-center, Randomized, Blank Parallel Controlled Clinical Study to Evaluate the Safety and Efficacy of Carbon Nanoparticles Suspension Injection in Surgical Treatment of Papillary Thyroid Carcinoma

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068502
Enrollment
Unknown
Registered
2023-02-21
Start date
2014-02-20
Completion date
Unknown
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Papillary Thyroid Carcinoma

Interventions

Group 1:thyroidectomy group: Unilateral thyroid lobectomy and isthmectomy + ipsilateral lymph node dissection at central region, performed after injecting carbon nanoparticles suspension injection.
Group 2:One-sided thyroid lobe + isthmus resection + ipsilateral central lymph node dissection, direct surgery without nano-carbon suspension injection
Group 3:thyroidectomy group: Total/subtotal thyroidectomy + at least unilateral lymph node dissection at central region + unilateral lymph node dissection at the lateral cervical region, performed aft
Group 4:thyroidectomy group: Total/subtotal thyroidectomy + at least unilateral lymph node dissection at central region + unilateral lymph node dissection at the lateral cervical region, performed dir

Sponsors

Tianjin Medical University Cancer Institute and Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Unilateral group: (1) Newly diagnosed, unilateral and single focus papillary thyroid carcinoma diagnosed by preoperative puncture pathological examination or intraoperative frozen pathological examination; (2) No cervical lymph node metastasis was found by imaging examination, and there was no indication for neck lymph node dissection on the affected side; (3) The surgical requirements of the patients in the group: unilateral thyroid lobe+isthmus resection+ipsilateral central lymph node dissection Note 2 Note 3; (4) The age is 18 to 70 years old; (5) Before joining the group, the laboratory examination results meet the following surgical conditions: neutrophil (ANC) >= 1.5 × 10^9/L, platelet (PLT) > 100 × 10^9/L, total bilirubin (TBI) = 1.5× 10^9/L, platelet (PLT) > = 100 × 10^9/L, total bilirubin (TBI) <= 2 × upper limit of normal value (2 mg/dl), alanine aminotransferase (ALT). (7) The patient has no psychological, family, social or geographical constraints that affect the compliance with the plan and the follow-up time; (8) Patients voluntarily participate and sign the informed consent form; (Note 4. If the contralateral gland is combined with single-focus papillary carcinoma, and the patients with lateral cervical lymph node metastasis are not considered, they can be included in the group; Note 5.

Exclusion criteria

Exclusion criteria: 1. Those who are considered to be combined with Hashimoto's thyroiditis; 2. Patients with active liver disease or abnormal liver function, ALT, AST, TBIL are more than 2 times the upper limit of normal value; 3. Renal impairment, Cr >= 2 times the upper limit of normal value or BUN >= 2 times the upper limit of normal value; 4. Subjects whose white blood cells are lower than the lower limit of normal value, or have definite anemia (hemoglobin is lower than the lower limit of normal value), or platelets are lower than the lower limit of normal value, or have other blood system diseases; 5. People with serious heart, lung, central nervous system diseases or malignant tumors; 6. People with mental illness or intellectual disability who cannot correctly describe their own feelings; 7. Severe blood coagulation disorder, that is, international normalized ratio (INR) or activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) > 1.5 times the upper limit of normal value; bleeding tendency; 8. Severe uncontrolled medical diseases, recent history of myocardial infarction (within 3 months); acute infection; 9. Pregnant or breastfeeding women; women of childbearing age participating unless adequate contraception is available; 10. Patients with uncontrolled severe hypertension and severe diabetes after intervention treatment; 11. Has a history of alcoholism, drug abuse or drug abuse; 12. Those who have participated in any drug trials within 3 months before enrollment; 13. Others considered by the investigator to be unsuitable for inclusion in this trial.

Design outcomes

Primary

MeasureTime frame
Parathyroid hormone (PTH);number of lymph nodes detected;number of tiny lymph nodes detected;identification and preservation of parathyroid glands;

Secondary

MeasureTime frame
Identification and protection of recurrent laryngeal nerves;

Countries

Cnina

Contacts

Public ContactMing Gao

Tianjin Medical University Cancer Institute and Hospital

gaoming68@aliyun.com+86 138 0208 8311

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026