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Study on the effect of mitoxantrone hydrochloride on thyroid papillary carcinoma

Study on the effect of mitoxantrone hydrochloride on thyroid papillary carcinoma

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081613
Enrollment
Unknown
Registered
2024-03-06
Start date
2024-03-06
Completion date
Unknown
Last updated
2024-03-11

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

Conditions

Papillary thyroid cancer

Interventions

Experimental group1 (Part 1):Nano-carbon was used during the operation
Control group (Part 1):Lymph node tracers should not be used intraoperatively
Experimental group 2 (Part 1):Mitoxantrone hydrochloride was used during the operation
Experimental group 3 (Part 2):Mitoxantrone hydrochloride was applied 1 day before surgery
Experimental Group 4 (Part 2):Mitoxantrone hydrochloride was applied 2 hours before surgery
Control group (Part 2):Lymph node tracers should not be used intraoperatively

Sponsors

The Second Affiliated Hospital of Harbin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 100 Years

Inclusion criteria

Inclusion criteria: 1. Gender is not limited; 2. Preoperative FNA and postoperative pathological type were papillary thyroid carcinoma; 3. The maximum diameter of the tumor was less than 2cm, which was confined to the unilateral thyroid gland; 4. cN0 or CN+ stage, but only central lymph node metastasis; 5. Patients with no obvious surgical contraindications, who underwent radical surgery for open unilateral thyroid cancer; 6, can comply with the research visit plan and other program requirements; 7. If you voluntarily participate in and sign the informed consent, you can participate in this study after signing the informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1. Patients with internal medical diseases accompanied by serious comorbidities cannot tolerate general anesthesia or conventional surgical positions; 2. Previous history of thyroid surgery or thermal ablation; 3. Hyperthyroidism combined with second-degree enlargement and retrosternal goiter; 4. Papillary carcinoma of thyroid gland has obvious extrandular invasion, such as invading recurrent laryngeal nerve, larynx, trachea, esophagus, etc. 5. Lymph node metastasis in the lateral region of papillary thyroid carcinoma; 6. It was identified as pathological subtype of papillary thyroid carcinoma with poor prognosis; 7. Papillary thyroid carcinoma with severe thyroid inflammatory disease. It is not appropriate to participate in this study, you should tell the doctor truthfully, and the doctor will make a comprehensive judgment according to your indicators.

Design outcomes

Secondary

MeasureTime frame
Operation time for gland resection and lymph node dissection;Intraoperative recurrent laryngeal nerve injury and its causes;Incidence of temporary and permanent recurrent laryngeal nerve injury;

Primary

MeasureTime frame
Serum PTH and calcium concentration before operation;Satisfaction of intraoperative staining in the lymph node tracer group;The number of parathyroid gland detected during operation, the number of in situ identification, the number of in situ retention, the number of misincision and the number of autologous transplantation;The number of intraoperative parathyroid misresection and self-extracted transplantation were calculated, and the detection rate and transplantation rate were calculated;The number of lymph node dissection and metastasis;Number of postoperative pathological parathyroid resection errors;Postoperative levels of parathyroid hormone and serum calcium ion at 1d, 3d and 1M;Incidence of temporary and permanent hypoparathyroidism;

Countries

China

Contacts

Public ContactTiefeng Shi

The Second Affiliated Hospital of Harbin Medical University

shitiefeng1970@163.com+86 139 3633 1006

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026