Radiofrequency (RF) could be technically feasible and effective in the treatment of lymph node metastases of differentiated thyroid cancer. It could constitute a minimally invasive and feasible therapeutic alternative in ambulatory, allowing a reduction of the tumoral volume sufficient to limit the symptoms even to induce a tumor remission, a normalization of the tumoral markers and a better quality of life. The aim of this study is to evaluate the anti-tumor echographic efficacy at 12 months of radiofrequency on lymph node (LN) metastasis of thyroid cancer
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
The radiofrequency will be performed under ultrasound control after local anesthesia by a trained operator, after finding the lesion to be treated by the operator. Medical device used: RF star electrode electrode\_Fixed (Starmed Co,Gyeonggi-do, Korea, French representative Cosysmed).
Hôpital Saint Louis
Paris, France
Treatment response.
Treatment success wil; be defined on the following three criteria that should be all fulfilled * Loss of metastatic aspect on ultrasonography * LN decreased volume at least 50% * no vascularization in Doppler
Time frame: 12 months
Percentage of patients with non-suspicious cyto-punction of treated LN at 6 months after RF
Time frame: 6 months
Percentage of patients without any new suspicious cervical lesion
Time frame: 3, 6, 12 and 24 months.
Response time
response time for partial response, major response and disappearance of lymph node at ultrasound.
Time frame: within 38 months
Reduction in thyroglobulin level in blood
Time frame: 3, 6, 12 and 24 months
Reduction in thyroglobulin antibody level in blood
Time frame: 3, 6, 12 and 24 months
Percentage of patient in tumor response
Tumor response is defined according American Thyroid Association's criteria
Time frame: 12 and 24 months
Percentage of patients without any new therapeutic event
Time frame: 12 and 24 months
Percentage of patients with good immediate tolerance
Time frame: day 0
Percentage of (either expected or unexpected) clinical complications
Time frame: 3, 6, 12 and 24 months
Percentage of patients who had a RF complete procedure
Time frame: day 0
Percentage of patients who had a RF incomplete procedure
Time frame: day 0
Anxiety
visual analog scale coted by the patient
Time frame: 3, 6, 12 and 24 months
36-item Medical Outcomes Study Short-Form Health Survey (SF-36)
it measures the quality of life
Time frame: 3, 6, 12 and 24 months
EuroQol (EQ-5D)
EQ-5D is a standardized instrument for measuring generic health status. Health status is measured in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Time frame: 3, 6, 12 and 24 months
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