A Multicenter Trial of PLA vs. Surgery for Treating PTMC

Not Applicable

• Conditions: Treatment Related Cancer; Thyroid Cancer

• Registration Number: NCT03377829
• Lead Sponsor: WeiWei Zhan

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 Timeline

• Study First Submitted: 2017-11-26
• Study Start: 2017-12-01
• Study First Submitted QC: 2017-12-14
• Study First Posted: 2017-12-19
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-18
• Last Update Posted: 2021-03-19
• Primary Completion: 2021-08-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Serological examination of thyroid function	up to 12 months	Hyperthyreosis or hypothyroidism.

Secondary Outcome Measures

Name	Time	Method
Recurrence rate	up to 12 months	The recurrence rate in the thyroid bed or regional lymph-nodes
Therapeutic Effect	up to 24 months	The rate of cure (defined as the absence of disease persistence at US examination and FNAB) between two methods.

Trial Locations

Locations (13)

Ultrasound Department, Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China

Ultrasound Department of the Third Hospital Affiliated to Zhongshan University; 🇨🇳 Guangzhou, Guangdong, China

Ultrasound Department, the Second Affiliated Hospital of Harbin Medical Univercity; 🇨🇳 Harbin, Heilongjiang, China

Ultrasound Department, the Xiangya Third Hospital of Zhongnan University; 🇨🇳 Changsha, Hunan, China

Ultrasound Department, the First Affliction Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China

Ultrasound Department, the First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China

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

Ultrasound Department, Ruijin Hospital Affiliated to Medical School of Shanghai Jiaotong University; 🇨🇳 Shanghai, Shanghai, China

The department of ultrasound ,second affiliated hospital of xi'an jiaotong university; 🇨🇳 Xi'an, Shanxi, China

Department of Ultrasonography, Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China

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