A Multicenter Trial of PLA vs. Surgery for Treating PTMC
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|ClinicalTrials.gov Identifier: NCT03377829|
Recruitment Status : Recruiting
First Posted : December 19, 2017
Last Update Posted : September 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Thyroid Cancer Treatment Related Cancer||Procedure: PLA Procedure: Thyroid Surgery||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multicenter Prospective Controlled Trial of Laser Ablation Versus Surgery for the Treatment of Papillary Thyroid Microcarcinoma|
|Actual Study Start Date :||December 1, 2017|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Percutaneous laser ablation(PLA)
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.
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.
Active Comparator: Surgery
Eligible participants with PTMC will be randomly assigned to this group and undergo total/subtotal thyroid surgery.
Procedure: Thyroid Surgery
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.
- Serological examination of thyroid function [ Time Frame: up to 12 months ]Hyperthyreosis or hypothyroidism.
- Recurrence rate [ Time Frame: up to 12 months ]The recurrence rate in the thyroid bed or regional lymph-nodes
- Therapeutic Effect [ Time Frame: up to 24 months ]The rate of cure (defined as the absence of disease persistence at US examination and FNAB) between two methods.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377829
|Contact: Lu Zhangfirstname.lastname@example.org|
|Contact: Wei Zhouemail@example.com|
|Ultrasound Department, Chinese PLA General Hospital||Recruiting|
|Beijing, Beijing, China, 010|
|Contact: Ming-bo Zhang +8613552744805 firstname.lastname@example.org|
|Contact: Fang Xie +8613717981887 email@example.com|
|Ultrasound Department of the Third Hospital Affiliated to Zhongshan University||Recruiting|
|Guangzhou, Guangdong, China, 020|
|Contact: Tao Wu +8613560332786 firstname.lastname@example.org|
|Contact: Jie Ren +8613925155583 email@example.com|
|Ultrasound Department, the Second Affiliated Hospital of Harbin Medical Univercity||Recruiting|
|Harbin, Heilongjiang, China, 451|
|Contact: Shuang-quan Jiang +8613704800486 firstname.lastname@example.org|
|Contact: Guo-qing Du +8615945164997|
|Ultrasound Department, the Xiangya Third Hospital of Zhongnan University||Recruiting|
|Changsha, Hunan, China, 731|
|Contact: Wen-gang Liu +8615116342563 email@example.com|
|Contact: Ping Zhou +8613974809881 firstname.lastname@example.org|
|Ultrasound Department, the First Affliction Hospital of Nanjing Medical University||Recruiting|
|Nanjing, Jiangsu, China, 025|
|Contact: Hong-yan Deng +8618262637897 email@example.com|
|Contact: Jing Hang +8613951827096 firstname.lastname@example.org|
|Ultrasound Department, the First Affiliated Hospital of Soochow University||Recruiting|
|Suzhou, Jiangsu, China, 557|
|Contact: Xiao-feng Wu +8618510516168 email@example.com|
|Contact: Feng-lin Dong +8613771978973 firstname.lastname@example.org|
|Ultrasound Department, First people's Hospital Affiliated to Medical School of Shanghai Jiaotong University||Recruiting|
|Shanghai, Shanghai, China, 021|
|Contact: Qiu-sheng Shi +8613311986321 email@example.com|
|Contact: Lian-fang Du +8613386259562 Du_lf@163.com|
|Ultrasound Department, Ruijin Hospital Affiliated to Medical School of Shanghai Jiaotong University||Recruiting|
|Shanghai, Shanghai, China, 021|
|Contact: Lu Zhang +8615021590551 firstname.lastname@example.org|
|Contact: Wei Zhou +8613681642667 email@example.com|
|The department of ultrasound ,second affiliated hospital of xi'an jiaotong university||Recruiting|
|Xi'an, Shanxi, China, 029|
|Contact: Wan-ying Jia +8615529619387 firstname.lastname@example.org|
|Contact: Jue Jiang +8618066736699 email@example.com|
|Department of Ultrasonography, Zhejiang Cancer Hospital||Recruiting|
|Hangzhou, Zhejiang, China, 571|
|Contact: Dong Xu +86057188122255 firstname.lastname@example.org|
|Contact: Li-ping Wang +85057188122252 email@example.com|
|Department of Ultrasound Medicine, the First Hospital Affiliated to Medical School of Zhejiang University||Recruiting|
|Hangzhou, Zhejiang, China, 571|
|Contact: Qi-yu Zhao +8613819140217 firstname.lastname@example.org|
|Department of Endocrinology, Regina Apostolorum Hospital||Recruiting|
|Contact: Enrico Papini email@example.com|
|Diagnostic Imaging, Regina Apostolorum Hospital||Recruiting|
|Contact: Giancarlo Bizzarri firstname.lastname@example.org|
|Principal Investigator:||WeiWei Zhan, Ph.D||Ruijin Hospital, affiliated to Medical School of Shanghai Jiaotong University|