A Multicenter Trial of PLA vs. Surgery for Treating PTMC

Last updated: March 18, 2021
Sponsor: WeiWei Zhan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Thyroid Cancer

Treatment

N/A

Clinical Study ID

NCT03377829
1001253709008902933
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Newly diagnosed PTMC (maximun diameter> = 5 mm and < = 10 mm) proved by fine needleaspiration 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 isolationfluid);
  • 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

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.

Study Design

Total Participants: 200
Study Start date:
December 01, 2017
Estimated Completion Date:
December 31, 2022

Study 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.

Connect with a study center

  • Ultrasound Department, Chinese PLA General Hospital

    Beijing, Beijing 010
    China

    Active - Recruiting

  • Ultrasound Department of the Third Hospital Affiliated to Zhongshan University

    Guangzhou, Guangdong 020
    China

    Active - Recruiting

  • Ultrasound Department, the Second Affiliated Hospital of Harbin Medical Univercity

    Harbin, Heilongjiang 451
    China

    Active - Recruiting

  • Ultrasound Department, the Xiangya Third Hospital of Zhongnan University

    Changsha, Hunan 731
    China

    Active - Recruiting

  • Ultrasound Department, the First Affliction Hospital of Nanjing Medical University

    Nanjing, Jiangsu 025
    China

    Active - Recruiting

  • Ultrasound Department, the First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 557
    China

    Active - Recruiting

  • Ultrasound Department, First people's Hospital Affiliated to Medical School of Shanghai Jiaotong University

    Shanghai, Shanghai 021
    China

    Active - Recruiting

  • Ultrasound Department, Ruijin Hospital Affiliated to Medical School of Shanghai Jiaotong University

    Shanghai, Shanghai 021
    China

    Active - Recruiting

  • The department of ultrasound ,second affiliated hospital of xi'an jiaotong university

    Xi'an, Shanxi 029
    China

    Active - Recruiting

  • Department of Ultrasonography, Zhejiang Cancer Hospital

    Hangzhou, Zhejiang 571
    China

    Active - Recruiting

  • Department of Ultrasound Medicine, the First Hospital Affiliated to Medical School of Zhejiang University

    Hangzhou, Zhejiang 571
    China

    Active - Recruiting

  • Department of Endocrinology, Regina Apostolorum Hospital

    Rome,
    Italy

    Active - Recruiting

  • Diagnostic Imaging, Regina Apostolorum Hospital

    Rome,
    Italy

    Active - Recruiting

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