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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiofrequency | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency (RF star electrode electrode_Fixed) | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment response. | Treatment success wil; be defined on the following three criteria that should be all fulfilled
| 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with non-suspicious cyto-punction of treated LN at 6 months after RF | 6 months | |
| Percentage of patients without any new suspicious cervical lesion | 3, 6, 12 and 24 months. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Saint Louis | Paris | Paris | 75010 | France | ||
| Hôpital Américain de Paris |
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Radiofrequency with local anesthesia: 1 episode of treatment
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|
| Response time |
response time for partial response, major response and disappearance of lymph node at ultrasound. |
| within 38 months |
| Reduction in thyroglobulin level in blood | 3, 6, 12 and 24 months |
| Reduction in thyroglobulin antibody level in blood | 3, 6, 12 and 24 months |
| Percentage of patient in tumor response | Tumor response is defined according American Thyroid Association's criteria | 12 and 24 months |
| Percentage of patients without any new therapeutic event | 12 and 24 months |
| Percentage of patients with good immediate tolerance | day 0 |
| Percentage of (either expected or unexpected) clinical complications | 3, 6, 12 and 24 months |
| Percentage of patients who had a RF complete procedure | day 0 |
| Percentage of patients who had a RF incomplete procedure | day 0 |
| Anxiety | visual analog scale coted by the patient | 3, 6, 12 and 24 months |
| 36-item Medical Outcomes Study Short-Form Health Survey (SF-36) | it measures the quality of life | 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. | 3, 6, 12 and 24 months |
| Neuilly-sur-Seine |
| France |
| Hôpital Laiboisière | Paris | France |