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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
Sponsor:
Information provided by (Responsible Party):
WeiWei Zhan, Ruijin Hospital

Tracking Information
First Submitted Date  ICMJE November 26, 2017
First Posted Date  ICMJE December 19, 2017
Last Update Posted Date September 17, 2019
Actual Study Start Date  ICMJE December 1, 2017
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2018)
Serological examination of thyroid function [ Time Frame: up to 12 months ]
Hyperthyreosis or hypothyroidism.
Original Primary Outcome Measures  ICMJE
 (submitted: December 14, 2017)
Influence on thyroid function [ Time Frame: up to 12 months ]
Hyperthyreosis or hypothyroidism.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multicenter Trial of PLA vs. Surgery for Treating PTMC
Official Title  ICMJE A Multicenter Prospective Controlled Trial of Laser Ablation Versus Surgery for the Treatment of Papillary Thyroid Microcarcinoma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Thyroid Cancer
  • Treatment Related Cancer
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: PLA
  • Active Comparator: Surgery
    Eligible participants with PTMC will be randomly assigned to this group and undergo total/subtotal thyroid surgery.
    Intervention: Procedure: Thyroid Surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 14, 2017)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lu Zhang +8615021590551 aluer2013@163.com
Contact: Wei Zhou +8613681642667 zw11468@126.com
Listed Location Countries  ICMJE China,   Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03377829
Other Study ID Numbers  ICMJE 1001253709008902933
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party WeiWei Zhan, Ruijin Hospital
Study Sponsor  ICMJE WeiWei Zhan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: WeiWei Zhan, Ph.D Ruijin Hospital, affiliated to Medical School of Shanghai Jiaotong University
PRS Account Ruijin Hospital
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP