A Multicenter Trial of PLA vs. Surgery for Treating PTMC

Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03377829
• Other study ID #: 1001253709008902933
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2021
• Source: Ruijin Hospital
• Contact: Lu Zhang
• Phone: +8615021590551
• Email: aluer2013[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2022
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms, Second Primary
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms
• Treatment Related Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Ultrasound Department, Chinese PLA General Hospital	Beijing	Beijing
China	Ultrasound Department, the Xiangya Third Hospital of Zhongnan University	Changsha	Hunan
China	Ultrasound Department of the Third Hospital Affiliated to Zhongshan University	Guangzhou	Guangdong
China	Department of Ultrasonography, Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Department of Ultrasound Medicine, the First Hospital Affiliated to Medical School of Zhejiang University	Hangzhou	Zhejiang
China	Ultrasound Department, the Second Affiliated Hospital of Harbin Medical Univercity	Harbin	Heilongjiang
China	Ultrasound Department, the First Affliction Hospital of Nanjing Medical University	Nanjing	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	Ultrasound Department, the First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	The department of ultrasound ,second affiliated hospital of xi'an jiaotong university	Xi'an	Shanxi
Italy	Department of Endocrinology, Regina Apostolorum Hospital	Rome
Italy	Diagnostic Imaging, Regina Apostolorum Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
WeiWei Zhan

Countries where clinical trial is conducted

China,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serological examination of thyroid function	Hyperthyreosis or hypothyroidism.	up to 12 months
Secondary	Recurrence rate	The recurrence rate in the thyroid bed or regional lymph-nodes	up to 12 months
Secondary	Therapeutic Effect	The rate of cure (defined as the absence of disease persistence at US examination and FNAB) between two methods.	up to 24 months