Neoplasms

Gland and Hormone Related Diseases

All Conditions

Thyroid Neoplasms

Thyroid Diseases

Neoplasms, Second Primary

Endocrine System Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anti-Arrhythmia Agents

Channel Blockers

Anesthetics

Lidocaine

Parathyroid Hormone

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.

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

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.

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.

Thyroid Surgery

Lu Zhang

Wei Zhou

Ming-bo Zhang

Fang Xie

Tao Wu

Jie Ren

Shuang-quan Jiang

Guo-qing Du

Wen-gang Liu

Ping Zhou

Hong-yan Deng

Jing Hang

Xiao-feng Wu

Feng-lin Dong

Qiu-sheng Shi

Lian-fang Du

Wan-ying Jia

Jue Jiang

Dong Xu

Li-ping Wang

Qi-yu Zhao

Enrico Papini

Giancarlo Bizzarri

WeiWei Zhan, Ph.D

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

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.

A Multicenter Trial of PLA vs. Surgery for Treating PTMC

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

The recurrence rate in the thyroid bed or regional lymph-nodes

The rate of cure (defined as the absence of disease persistence at US examination and FNAB) between two methods.

WeiWei Zhan

Director, Head of Ultrasound Department; Clinical Professor

Carcinoma

Carcinoma, Papillary

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Participants with papillary microcarcinoma (PTMC) who have elected to proceed with thyroidectomy rather than an observational management approach will be considered as potential candidates for this trial.

Percutaneous Laser Ablation / PLA will be carried out in a single session by advancing one 21-gauge spinal needle into the target lesions under real time US guidance.

Percutaneous Laser Ablation (PLA)

R. Michael Tuttle, MD

Stephen Solomon, MD

The purpose of this study is to explore whether percutaneous laser ablation (PLA) is a safe and effective alternative to removing papillary thyroid microcarcinoma (PTMC) with surgery.

Laser Ablation of Papillary Thyroid Microcarcinoma

Pilot Study to Evaluate the Safety and Efficacy of Percutaneous Laser Ablation of Thyroid Papillary Microcarcinoma

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Complete thermal ablation of the targeted PTMC (T1aN0M0) as determined by histological examination of thyroid tissue obtained by either thyroid lobectomy or total thyroidectomy 6 months after PLA.

Memorial Sloan Kettering Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Multicenter Trial of PLA vs. Surgery for Treating PTMC	NCT03377829	Thyroid Cancer Treatment Relat...	PLA Thyroid Surgery	18 Years -	Ruijin Hospital
A Multicenter Trial of PLA vs. Surgery for Treating PTMC	NCT03377829	Thyroid Cancer Treatment Relat...	PLA Thyroid Surgery	18 Years -	Ruijin Hospital
Laser Ablation of Papillary Thyroid Microcarcinoma	NCT04623801	Papillary Thyro... Thyroid Thyroid Cancer	Percutaneous La...	18 Years -	Memorial Sloan Kettering Cancer Center
Laser Ablation of Papillary Thyroid Microcarcinoma	NCT04623801	Papillary Thyro... Thyroid Thyroid Cancer	Percutaneous La...	18 Years -	Memorial Sloan Kettering Cancer Center
Laser Ablation of Papillary Thyroid Microcarcinoma	NCT04623801	Papillary Thyro... Thyroid Thyroid Cancer	Percutaneous La...	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for pla

Every month we try and update this database with for pla cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pla

Every month we try and update this database with for pla cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pla cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.