Status:
UNKNOWN
A Multicenter Trial of PLA vs. Surgery for Treating PTMC
Lead Sponsor:
WeiWei Zhan
Conditions:
Thyroid Cancer
Treatment Related Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 ligh...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03377829
Start Date
December 1 2017
End Date
December 31 2022
Last Update
March 19 2021
Active Locations (13)
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1
Ultrasound Department, Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 010
2
Ultrasound Department of the Third Hospital Affiliated to Zhongshan University
Guangzhou, Guangdong, China, 020
3
Ultrasound Department, the Second Affiliated Hospital of Harbin Medical Univercity
Harbin, Heilongjiang, China, 451
4
Ultrasound Department, the Xiangya Third Hospital of Zhongnan University
Changsha, Hunan, China, 731