A Multicenter Trial of PLA vs. Surgery for Treating PTMC

WeiWei Zhan

Status: Unknown

Conditions: Thyroid Cancer; Treatment Related Cancer

Treatments: Procedure: Thyroid Surgery; Procedure: PLA

Study type: Interventional

Funder types: Other

Identifiers

NCT03377829

1001253709008902933

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

Percutaneous laser ablation(PLA)

Experimental group

Description:

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.

Treatment:

Procedure: PLA

Surgery

Active Comparator group

Description:

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

Treatment:

Procedure: Thyroid Surgery