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This is a multicenter prospective controlled trial of percutaneous laser ablation(PLA) versus conventional surgery for the treatment of papillary thyroid microcarcinoma (PTMC).
PLA is the acronym for "Percutaneous Laser Ablation". The treatment consists in the destruction (ablation) of Papillary Thyroid Micro Carcinoma by means of optical fibers that deliver high-energy light (laser) into the lesion through skin puncturing (percutaneous). The procedure is performed under ultrasound imaging guidance (ultrasound-guided). The destruction of the lesion occurs through overheating and coagulation. PLA, however, still needs a large-scale validation trial in order to be considered as an effective alternative to both surgery or follow-up for low-risk PTMC in elderly patients and/or in patients with co-morbidities that might expose the patients to a high surgical risk.
After a comprehensive information, patients will be consecutively assigned to Group 1 (surgery, preferentially lobectomy) or to Group 2 (percutaneous laser ablation, performed according to the attached procedure).Peri and post-operative complications, need of drug treatment, length of hospital admission and customer satisfaction will be registered.
The aims of this study are as follows: 1.To establish the rate of cure or partial ablation; 2.To compare the complication rate, time expenditure and costs of two procedures; 3.To assess changes in thyroid function and the need of substitution therapy with two procedures; 4.To assess the tolerability of the procedure, the customer satisfaction and the impact on the quality of life of the patients between conventional surgery and PLA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Percutaneous laser ablation(PLA) | Experimental | Eligible participants with PTMC will be randomly assigned to this group and undergo percutaneous laser ablation(PLA). All the process is under the detection of real-time ultrasound.After surgery, all the patients will accept contrast-enhanced ultrasound(CEUS), regular ultrasound follow-up, thyroid functional detection, fine-needle aspiration biopsy(FNAB), neck CT.Per and post-operative complications, need of drug treatment, length of hospital admission and customer satisfaction will be registered. |
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| Surgery | Active Comparator | Eligible participants with PTMC will be randomly assigned to this group and undergo total/subtotal thyroid surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PLA | Procedure | During the PLA, the patient is in supine position with head extended: the physician, ultrasound assistant and trained nurse work within the sterile field. Under constant ultrasound image guidance and after local anesthesia by means of 2% xylocaine infiltration, thin needles (21G) are positioned in the thyroid lesion, within safety distance from the surrounding anatomical structures. A plane-cut tip fiber optics is inserted into the PTMC through the needle. The laser at 1064 nm wavelength is turned on for 10 minutes until the pre-established energy dose is attained. There is usually no pain or very limited pain. |
| Measure | Description | Time Frame |
|---|---|---|
| Serological examination of thyroid function | Hyperthyreosis or hypothyroidism. | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate | The recurrence rate in the thyroid bed or regional lymph-nodes | up to 12 months |
| Therapeutic Effect | The rate of cure (defined as the absence of disease persistence at US examination and FNAB) between two methods. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lu Zhang | Contact | +8615021590551 | aluer2013@163.com | |
| Wei Zhou | Contact | +8613681642667 | zw11468@126.com |
| Name | Affiliation | Role |
|---|---|---|
| WeiWei Zhan, Ph.D | Ruijin Hospital, affiliated to Medical School of Shanghai Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ultrasound Department, Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 010 | China |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D016609 | Neoplasms, Second Primary |
| C563277 | Papillary Thyroid Microcarcinoma |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| Thyroid Surgery | Procedure | Patients are routinely disinfected and spread the drapes after general anesthesia. Neck skin, fat, placenta muscle are incised successively. The flap is separated to the upper edge of thyroid cartilage, neck white line is incised and anterior muscle group is separated. Then both sides thyroid lobes are exposed. Cut off the isthmus, ligature the thyroid artery, cut off the upper pole. Ligature and cut off the ipsilateral thyroid vein. Reveal and protect the ipsilateral recurrent laryngeal nerve and the parathyroid gland during the entire process. Finally patient is performed total thyroidectomy or subtotal thyroidectomy. |
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| up to 24 months |
| Ultrasound Department of the Third Hospital Affiliated to Zhongshan University | Recruiting | Guangzhou | Guangdong | 020 | China |
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| Ultrasound Department, the Second Affiliated Hospital of Harbin Medical Univercity | Recruiting | Harbin | Heilongjiang | 451 | China |
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| Ultrasound Department, the Xiangya Third Hospital of Zhongnan University | Recruiting | Changsha | Hunan | 731 | China |
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| Ultrasound Department, the First Affliction Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 025 | China |
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| Ultrasound Department, the First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 557 | China |
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| Ultrasound Department, First people's Hospital Affiliated to Medical School of Shanghai Jiaotong University | Recruiting | Shanghai | Shanghai Municipality | 021 | China |
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| Ultrasound Department, Ruijin Hospital Affiliated to Medical School of Shanghai Jiaotong University | Recruiting | Shanghai | Shanghai Municipality | 021 | China |
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| The department of ultrasound ,second affiliated hospital of xi'an jiaotong university | Recruiting | Xi’an | Shanxi | 029 | China |
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| Department of Ultrasonography, Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 571 | China |
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| Department of Ultrasound Medicine, the First Hospital Affiliated to Medical School of Zhejiang University | Recruiting | Hangzhou | Zhejiang | 571 | China |
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| Department of Endocrinology, Regina Apostolorum Hospital | Recruiting | Rome | Italy |
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| Diagnostic Imaging, Regina Apostolorum Hospital | Recruiting | Rome | Italy |
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| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |