A Multicenter Trial of PLA vs. Surgery for Treating PTMC

March 18, 2021 updated by: WeiWei Zhan

A Multicenter Prospective Controlled Trial of Laser Ablation Versus Surgery for the Treatment of Papillary Thyroid Microcarcinoma

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 010
        • Recruiting
        • Ultrasound Department, Chinese PLA General Hospital
        • Contact:
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 020
        • Recruiting
        • Ultrasound Department of the Third Hospital Affiliated to Zhongshan University
        • Contact:
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 451
        • Recruiting
        • Ultrasound Department, the Second Affiliated Hospital of Harbin Medical Univercity
        • Contact:
        • Contact:
          • Guo-qing Du
          • Phone Number: +8615945164997
    • Hunan
      • Changsha, Hunan, China, 731
        • Recruiting
        • Ultrasound Department, the Xiangya Third Hospital of Zhongnan University
        • Contact:
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 025
        • Recruiting
        • Ultrasound Department, the First Affliction Hospital of Nanjing Medical University
        • Contact:
        • Contact:
      • Suzhou, Jiangsu, China, 557
        • Recruiting
        • Ultrasound Department, the First Affiliated Hospital of Soochow University
        • Contact:
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 021
        • Recruiting
        • Ultrasound Department, First people's Hospital Affiliated to Medical School of Shanghai Jiaotong University
        • Contact:
        • Contact:
      • Shanghai, Shanghai, China, 021
        • Recruiting
        • Ultrasound Department, Ruijin Hospital Affiliated to Medical School of Shanghai Jiaotong University
        • Contact:
        • Contact:
    • Shanxi
      • Xi'an, Shanxi, China, 029
        • Recruiting
        • The department of ultrasound ,second affiliated hospital of xi'an jiaotong university
        • Contact:
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 571
        • Recruiting
        • Department of Ultrasonography, Zhejiang Cancer Hospital
        • Contact:
        • Contact:
      • Hangzhou, Zhejiang, China, 571
        • Recruiting
        • Department of Ultrasound Medicine, the First Hospital Affiliated to Medical School of Zhejiang University
        • Contact:
  • Italy
      • Rome, Italy
        • Recruiting
        • Department of Endocrinology, Regina Apostolorum Hospital
        • Contact:
      • Rome, Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serological examination of thyroid function
Time Frame: up to 12 months
Hyperthyreosis or hypothyroidism.
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence rate
Time Frame: up to 12 months
The recurrence rate in the thyroid bed or regional lymph-nodes
up to 12 months
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.
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

WeiWei Zhan

Investigators

  • Principal Investigator: WeiWei Zhan, Ph.D, Ruijin Hospital, affiliated to Medical School of Shanghai Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2017

Primary Completion (ANTICIPATED)

August 31, 2021

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

November 26, 2017

First Submitted That Met QC Criteria

December 14, 2017

First Posted (ACTUAL)

December 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 19, 2021

Last Update Submitted That Met QC Criteria

March 18, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1001253709008902933

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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