Spots Global Cancer Trial Database for A Multicenter Trial of PLA vs. Surgery for Treating PTMC
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Trial Identification
Brief Title: 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 ID: NCT03377829
Study Description
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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Ultrasound Department, Chinese PLA General Hospital, Beijing, Beijing, China
Ultrasound Department of the Third Hospital Affiliated to Zhongshan University, Guangzhou, Guangdong, China
Ultrasound Department, the Second Affiliated Hospital of Harbin Medical Univercity, Harbin, Heilongjiang, China
Ultrasound Department, the Xiangya Third Hospital of Zhongnan University, Changsha, Hunan, China
Ultrasound Department, the First Affliction Hospital of Nanjing Medical University, Nanjing, Jiangsu, China
Ultrasound Department, the First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China
Ultrasound Department, First people's Hospital Affiliated to Medical School of Shanghai Jiaotong University, Shanghai, Shanghai, China
Ultrasound Department, Ruijin Hospital Affiliated to Medical School of Shanghai Jiaotong University, Shanghai, Shanghai, China
The department of ultrasound ,second affiliated hospital of xi'an jiaotong university, Xi'an, Shanxi, China
Department of Ultrasonography, Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Department of Ultrasound Medicine, the First Hospital Affiliated to Medical School of Zhejiang University, Hangzhou, Zhejiang, China
Department of Endocrinology, Regina Apostolorum Hospital, Rome, , Italy
Diagnostic Imaging, Regina Apostolorum Hospital, Rome, , Italy
Contact Details
Name: WeiWei Zhan, Ph.D
Affiliation: Ruijin Hospital, affiliated to Medical School of Shanghai Jiaotong University
Role: PRINCIPAL_INVESTIGATOR
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