NCT03377829

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).

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Longer than P75 for not_applicable

Geographic Reach
2 countries

13 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 19, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 19, 2021

Status Verified

March 1, 2021

Enrollment Period

3.8 years

First QC Date

November 26, 2017

Last Update Submit

March 18, 2021

Conditions

Thyroid CancerTreatment Related Cancer

Keywords

Papillary Thyroid MicrocarcinomaPercutaneous Laser Ablationthyroidectomyultrasonographydouble-blind

Outcome Measures

Primary Outcomes (1)

  • Serological examination of thyroid function

    Hyperthyreosis or hypothyroidism.

    up to 12 months

Secondary Outcomes (2)

  • Recurrence rate

    up to 12 months

  • Therapeutic Effect

    up to 24 months

Study Arms (2)

Percutaneous laser ablation(PLA)

EXPERIMENTAL

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

Surgery

ACTIVE COMPARATOR

Eligible participants with PTMC will be randomly assigned to this group and undergo total/subtotal thyroid surgery.

Procedure: Thyroid Surgery

Interventions

PLAPROCEDURE

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.

Percutaneous laser ablation(PLA)
Thyroid SurgeryPROCEDURE

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.

Surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Ultrasound Department, Chinese PLA General Hospital

Beijing, Beijing Municipality, 010, China

RECRUITING

Ultrasound Department of the Third Hospital Affiliated to Zhongshan University

Guangzhou, Guangdong, 020, China

RECRUITING

Ultrasound Department, the Second Affiliated Hospital of Harbin Medical Univercity

Harbin, Heilongjiang, 451, China

RECRUITING

Ultrasound Department, the Xiangya Third Hospital of Zhongnan University

Changsha, Hunan, 731, China

RECRUITING

Ultrasound Department, the First Affliction Hospital of Nanjing Medical University

Nanjing, Jiangsu, 025, China

RECRUITING

Ultrasound Department, the First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 557, China

RECRUITING

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

Shanghai, Shanghai Municipality, 021, China

RECRUITING

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

Shanghai, Shanghai Municipality, 021, China

RECRUITING

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

Xi’an, Shanxi, 029, China

RECRUITING

Department of Ultrasonography, Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 571, China

RECRUITING

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

Hangzhou, Zhejiang, 571, China

RECRUITING

Department of Endocrinology, Regina Apostolorum Hospital

Rome, Italy

RECRUITING

Diagnostic Imaging, Regina Apostolorum Hospital

Rome, Italy

RECRUITING

MeSH Terms

Conditions

Thyroid NeoplasmsNeoplasms, Second PrimaryPapillary Thyroid Microcarcinoma

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • WeiWei Zhan, Ph.D

    Ruijin Hospital, affiliated to Medical School of Shanghai Jiaotong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lu Zhang

CONTACT

+8615021590551aluer2013@163.com

Wei Zhou

CONTACT

+8613681642667zw11468@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Head of Ultrasound Department; Clinical Professor

Study Record Dates

First Submitted

November 26, 2017

First Posted

December 19, 2017

Study Start

December 1, 2017

Primary Completion

August 31, 2021

Study Completion

December 31, 2022

Last Updated

March 19, 2021

Record last verified: 2021-03

Locations

CN(11)IT(2)