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A Multicenter Trial of PLA vs. Surgery for Treating PTMC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03377829
Recruitment Status : Recruiting
First Posted : December 19, 2017
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
WeiWei Zhan, Ruijin Hospital

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).

Condition or disease Intervention/treatment Phase
Thyroid Cancer Treatment Related Cancer Procedure: PLA Procedure: Thyroid Surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid

Arm Intervention/treatment
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.
Procedure: PLA
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.




Primary Outcome Measures :
  1. Serological examination of thyroid function [ Time Frame: up to 12 months ]
    Hyperthyreosis or hypothyroidism.


Secondary Outcome Measures :
  1. Recurrence rate [ Time Frame: up to 12 months ]
    The recurrence rate in the thyroid bed or regional lymph-nodes

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Lu Zhang +8615021590551 aluer2013@163.com
Contact: Wei Zhou +8613681642667 zw11468@126.com

Locations
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China, Beijing
Ultrasound Department, Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 010
Contact: Ming-bo Zhang    +8613552744805    owsifanduizhe@126.com   
Contact: Fang Xie    +8613717981887    lmsh1225@163.com   
China, Guangdong
Ultrasound Department of the Third Hospital Affiliated to Zhongshan University Recruiting
Guangzhou, Guangdong, China, 020
Contact: Tao Wu    +8613560332786    wutao83@126.com   
Contact: Jie Ren    +8613925155583    13925155583@126.com   
China, Heilongjiang
Ultrasound Department, the Second Affiliated Hospital of Harbin Medical Univercity Recruiting
Harbin, Heilongjiang, China, 451
Contact: Shuang-quan Jiang    +8613704800486    23237003@qq.com   
Contact: Guo-qing Du    +8615945164997      
China, Hunan
Ultrasound Department, the Xiangya Third Hospital of Zhongnan University Recruiting
Changsha, Hunan, China, 731
Contact: Wen-gang Liu    +8615116342563    593987695@qq.com   
Contact: Ping Zhou    +8613974809881    zhouping1000@hotmail.com   
China, Jiangsu
Ultrasound Department, the First Affliction Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 025
Contact: Hong-yan Deng    +8618262637897    603655097@qq.com   
Contact: Jing Hang    +8613951827096    hangjing411714@163.com   
Ultrasound Department, the First Affiliated Hospital of Soochow University Recruiting
Suzhou, Jiangsu, China, 557
Contact: Xiao-feng Wu    +8618510516168    xiaofengwu0115@163.com   
Contact: Feng-lin Dong    +8613771978973    13771978973@163.com   
China, Shanghai
Ultrasound Department, First people's Hospital Affiliated to Medical School of Shanghai Jiaotong University Recruiting
Shanghai, Shanghai, China, 021
Contact: Qiu-sheng Shi    +8613311986321    sqs19631989@163.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    aluer2013@163.com   
Contact: Wei Zhou    +8613681642667    zw11468@126.com   
China, Shanxi
The department of ultrasound ,second affiliated hospital of xi'an jiaotong university Recruiting
Xi'an, Shanxi, China, 029
Contact: Wan-ying Jia    +8615529619387    jia331@126.com   
Contact: Jue Jiang    +8618066736699    13720721677@163.com   
China, Zhejiang
Department of Ultrasonography, Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 571
Contact: Dong Xu    +86057188122255    xudong@zjcc.org.cn   
Contact: Li-ping Wang    +85057188122252    wanglp@zjcc.org.cn   
Department of Ultrasound Medicine, the First Hospital Affiliated to Medical School of Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 571
Contact: Qi-yu Zhao    +8613819140217    derman2000@126.com   
Italy
Department of Endocrinology, Regina Apostolorum Hospital Recruiting
Rome, Italy
Contact: Enrico Papini       papinie@gmail.com   
Diagnostic Imaging, Regina Apostolorum Hospital Recruiting
Rome, Italy
Contact: Giancarlo Bizzarri       bizzarrigiancarlo@libero.it   
Sponsors and Collaborators
WeiWei Zhan
Investigators
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Principal Investigator: WeiWei Zhan, Ph.D Ruijin Hospital, affiliated to Medical School of Shanghai Jiaotong University
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Responsible Party: WeiWei Zhan, Director, Head of Ultrasound Department; Clinical Professor, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03377829    
Other Study ID Numbers: 1001253709008902933
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by WeiWei Zhan, Ruijin Hospital:
Papillary Thyroid Microcarcinoma
Percutaneous Laser Ablation
thyroidectomy
ultrasonography
double-blind
Additional relevant MeSH terms:
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Thyroid Neoplasms
Neoplasms, Second Primary
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms