Papillary carcinoma of thyroid
Conditions
Interventions
Experimental group:TSH suppression therapy and radioactive 131I therapy after total thyroidectomy
Control group:TSH suppression therapy only after total thyroidectomy
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: A newly diagnosed PTC patient aged 18-70 years who was confirmed by preoperative fine or thick needle aspiration cytology or histology. 2) Indications for total thyroidectomy: based on the 2012 "Guidelines for the diagnosis and treatment of thyroid nodules and differentiated thyroid cancer"(Chinese version) shall prevail. Conform to any of the following: ? bilateral cancer; ? Highly invasive subtypes, such as high cell type, columnar cell type, diffuse sclerosis type and solid subtype of PTC; ? There is local and remote metastasis 131I treatment after operation; ? With extraglandular invasion (such as subcutaneous adipose tissue, muscle, trachea, esophagus, carotid artery or mediastinal invasion); ? The maximum diameter of the primary focus is>1cm; ? There are high risk factors for thyroid cancer; ? Isthmus PTC; ? Accompanied by contralateral thyroid nodules; ? BRAF mutation positive patients. 3) The indications for bilateral central lymph node dissection are in accordance with any of the following: ? bilateral cancer; ? T3 and T4 tumors; ? Lymph node metastasis in lateral cervical region; ? Highly invasive subtype; ? Anterior laryngeal and tracheal lymph node metastasis; ? Lymph node enlargement in the contralateral central region was found on imaging or surgery; ? Isthmus PTC; ? The maximum diameter of tumor is>1cm; ? BRAF mutation positive patients; ? The patient has a strong desire to be more thorough. 4) According to the 2015 ATA guidelines, patients who were assessed as moderate to moderate risk of recurrence (any one): ? tumor with thyroid soft tissue invasion can be seen under microscope; ? After 131I treatment, there was abnormal iodine uptake in the neck on the first whole-body iodine scan; ? Subtypes with high malignancy (high cell, columnar cell, diffuse sclerosis, etc.) or accompanied by vascular invasion; ? > For pN1 with 5 lymph nodes metastasis, the diameter of metastatic lymph nodes is less than 3cm; ? PTC in gland, primary tumor diameter is 1-4cm, BRAF V600E mutation; ? Multifocal PTMC with minor extraglandular invasion and BRAF V600E mutation. 5) He has not received radioactive 131I diagnosis or treatment in the past. 6) The results of laboratory examination before enrollment were in line with the operation conditions, and there was no contraindication for operation. 7) There are no psychological, family, social or geographical restrictive factors that may affect the compliance of the protocol and the follow-up time; 8) Volunteer to participate, sign the informed consent form, and be willing to follow up for a long time.
Exclusion criteria
Exclusion criteria: Those who have one of the following conditions can not be included in the clinical trial: 1) Preoperative fine-needle or coarse-needle puncture indicates that patients with non-PTC or suspected PTC; 2) Patients assessed as low or high risk of recurrence according to ATA guidelines 3) Pregnant women and lactating women (female patients were excluded by routine urine pregnancy test); 4) Previously allergic to 131I; 5) Those who cannot tolerate surgery for various reasons; 6) The researcher believes that it is not suitable for the group; 7) Patients with poor compliance and unwilling to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Thyroglobulin, HTG;TgAb;High frequency ultrasound of neck;Cervicothoracic enhanced CT; | — |
Secondary
| Measure | Time frame |
|---|---|
| Thyrotropin, TSH;thyroid hormone, FT3;FT4; | — |
Countries
China
Contacts
Public ContactAnping Su
West China Hospital of Sichuan University
Outcome results
None listed