Benign Thyroid Nodules
Conditions
Interventions
Clinical Trial Group:High intensity focused ultrasound ablation
Clinical Control group:Observation, No intervention
Sponsors
Zhejiang Provincial People's Hospita
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Male or female patients = 18 years old and<70 years old; (2) Three basic thyroid function tests (TSH, FT3, FT4 levels) within the past 2 weeks indicates normal; (3) The target thyroid nodules must meet all the following conditions a) Single nodule, 1 cm= maximum diameter=4 cm; b) There are cosmetic symptoms, local compression or swallowing symptoms related to thyroid nodules, or slowly-growing nodular goiter; c) Solid or predominantly solid nodules (solid area = 70%), or cystic-solid crinkled nodules; d) ACR TI-RADS Category (2017 version) = TR3, and the FNA cyto-pathological Bethesda report conducted by the research center itself once within the past 6 months is Category II, or CNB histopathological diagnosis is benign; Or ACR TI-RADS Category (2017 version) is TR4, but the FNA cyto-pathological Bethesda report conducted by the research center itself twice in the past 6 months is Category II, or the CNB histopathology diagnosis is benign; e) The lowest edge of the nodules is not lower than the upper edge of the clavicle when the neck is tilted back and stretched; f) The distance between the posterior capsule of the nodule and the skin is less than 40mm; g) There is no thick or marginal calcification within the nodule which causes blurring of the target area on the ultrasound image; h) There is no scar protruding from the skin surface on the treatment pathway. (4) If there are multiple nodules in the thyroid lobe on the treatment target side, all the following conditions must be met: a) The number of nodules with a diameter of 5-10mm is =2 (except for treatment nodules), and the number of nodules with a diameter of 0-5mm is not limited; b) ACR TI-RADS Category (2017 version) = TR3. (5) If there are nodules in the non-treated thyroid lobe, one of the following conditions must be met: a) The maximum diameter is <1 cm, and ACR TI-RADS Category (2017 version) = TR3. b) 1 cm = the maximum diameter of the nodule < 2 cm, and there is only one nodule, and the ACR TI-RADS Category (2017 version) = TR3 (6) The function of bilateral vocal cords under the laryngoscope conducted by the research center itself is normal; (7) Patients refuse or can not tolerate the invasive surgery; (8) Patients have voluntarily signed the Informed Consent.
Exclusion criteria
Exclusion criteria: (1) Besides the target nodules, there is the nodule in the thyroid gland which meets the following conditions: the volume of the nodule increases by over 50%, or two diameter lines increase by more than 20% (and more than 2mm) within the past half a year; (2) The ultrasonic diagnosis conducted by the research center itself suggests that the possibility of follicular tumors can not be ruled out; (3) Those with the known history of thyroid cancer or other neck tumors such as nasopharyngeal carcinoma; (4) Those with the head and/or neck disease that prevents the stretch of the neck; (5) Those currently in the acute phase or unstable phase of any disease; (6) Those with a history of head and neck, lung or systematic infection in the past 2 weeks; (7) Those with a history of arrhythmia in the past, or coronary heart disease, heart valve disease, or heart failure in the past 6 months; (8) Those with a history of COPD or current asthma attack period; (9) Those with hepatic insufficiency (alanine aminotransferase ALT or aspartate aminotransferase AST is 2.5 times higher than the upper limit of the normal reference range); (10) Those with renal insufficiency (serum creatinine levels >221umol/L for males and serum creatinine levels >177umol/L for females); (11) Those currently suffering from blood system diseases or bleeding tendencies, or those who currently need to continue to take antiplatelet and anticoagulant drugs; (12) Pregnant or lactating women, or women who plan the pregnancy during the study period; (13) Those with analgesic/anesthesia contraindications; (14) Those who are currently participating in other clinical trial or have participated in other clinical trials within the past 3 months; (15) Those with Alzheimer's disease, or brain cognitive dysfunction etc.; (16) Those suffering from acute thyroiditis or subacute thyroiditis; (17) Those Suffering from severe thyroid dysfunction; (18) Those with the history of radiation therapy for the neck or the neck surgery which affects the thyroid adhesion; (19) Those who are judged by the researchers to be unsuitable for participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Therapeutic Success Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ablation Efficacy;VRR(Volume Reduction Rate) of the thyroid nodules after the treatment;Symptom score;Pain score;Device satisfaction evaluation; | — |
Countries
China
Contacts
Public ContactTan Zhuo
Zhejiang Provincial People's Hospital,China
Outcome results
None listed