Clinical trial NCT03377829: A Multicenter Trial of PLA vs. Surgery for Treating PTMC
Official title: A Multicenter Prospective Controlled Trial of Laser Ablation Versus Surgery for the Treatment of Papillary Thyroid Microcarcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Cancer
Treatment Related Cancer
Keywords: Papillary Thyroid Microcarcinoma
Percutaneous Laser Ablation
thyroidectomy
ultrasonography
double-blind
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter prospective controlled trial of percutaneous laser ablation(PLA) versus conventional surgery for the treatment of papillary thyroid microcarcinoma (PTMC).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed PTMC (maximun diameter\> = 5 mm and \< = 10 mm) proved by fine needle aspiration biopsy with good thyroid function;
* Age≥ 18 Y;
* Single nodule without thyroid capsule contact;
* There had more than 3mm distance between nodules and trachea, carotid artery, recurrent laryngeal nerve (The distance should up to 5mm after injection of isolation fluid);
* No coarse calcification or eggshell-like calcification;
* Imaging examination without local or distant metastasis;
* Without chemotherapy, radiotherapy and other related therapies;
* A complete clinical, pathological and follow-up information;
* Get informed consent signed by the patient or family member.

Exclusion Criteria:

* Multifocal PTMC;
* Combined with other types of thyroid cancer or hyperthyroidism;
* Lesion contact with thyroid capsule or located in the isthmus;
* Serious coagulation dysfunction;
* Contralateral vocal cord paralysis;
* Imaging examination with local or distant metastasis;
* Active Tuberculosis and HIV-positive patients;
* Patients can not understand or follow research protocol;
* Pregnant woman.

Primary outcomes:
measure: Serological examination of thyroid function
timeFrame: up to 12 months
Secondary outcomes:
measure: Recurrence rate
timeFrame: up to 12 months
measure: Therapeutic Effect
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Ultrasound Department, Chinese PLA General Hospital
state: Beijing
city: Guangzhou
country: China
facility: Ultrasound Department of the Third Hospital Affiliated to Zhongshan University
state: Guangdong
city: Harbin
country: China
facility: Ultrasound Department, the Second Affiliated Hospital of Harbin Medical Univercity
state: Heilongjiang
city: Changsha
country: China
facility: Ultrasound Department, the Xiangya Third Hospital of Zhongnan University
state: Hunan
city: Nanjing
country: China
facility: Ultrasound Department, the First Affliction Hospital of Nanjing Medical University
state: Jiangsu
city: Suzhou
country: China
facility: Ultrasound Department, the First Affiliated Hospital of Soochow University
state: Jiangsu
city: Shanghai
country: China
facility: Ultrasound Department, First people's Hospital Affiliated to Medical School of Shanghai Jiaotong University
state: Shanghai
city: Shanghai
country: China
facility: Ultrasound Department, Ruijin Hospital Affiliated to Medical School of Shanghai Jiaotong University
state: Shanghai
city: Xi'an
country: China
facility: The department of ultrasound ,second affiliated hospital of xi'an jiaotong university
state: Shanxi
city: Hangzhou
country: China
facility: Department of Ultrasonography, Zhejiang Cancer Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Department of Ultrasound Medicine, the First Hospital Affiliated to Medical School of Zhejiang University
state: Zhejiang
city: Rome
country: Italy
facility: Department of Endocrinology, Regina Apostolorum Hospital
city: Rome
country: Italy
facility: Diagnostic Imaging, Regina Apostolorum Hospital
Study officials:
affiliation: Ruijin Hospital, affiliated to Medical School of Shanghai Jiaotong University
name: WeiWei Zhan, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: