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

Thyroid Nodule

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Single session with standardized approach: One or two fibers will be used for treatments including one to three illuminations with a fixed output power of 3 W, using the pullback technique. Energy for each emission will be 1200-1800J based on nodule volume. The treatment is performed under local anesthesia and conscious sedation.

Percutaneous Laser Ablation

Single session with standardized approach: A radiofrequency generator and a 17-gauge, 15-cm electrode with a 1-cm active tip will be used. A transisthmic approach along the short axis of the nodule will be used and the nodules will be managed with the moving-shot technique. 60 W of radiofrequency outpower will be used for all nodules. The treatment is performed under local anesthesia and conscious sedation

Percutaneous Radiofrequency Ablation

Roberto Cianni

The purpose of this study is to prospectively compare percutaneous radiofrequency ablation (RFA) versus percutaneous laser ablation (LA) for the treatment of solid thyroid nodules.

Nodular thyroid disease is a common clinical problem whose prevalence increases with age and with a more widespread use of thyroid ultrasonography. Although most thyroid nodules are benign and need only periodic monitoring, some may require treatment for associated pressure and/or cosmetic symptoms. Although thyroid surgery is the main therapeutic approach for compressive thyroid nodules, it may be associated with several drawbacks. Long-term levothyroxine suppression treatment in elderly patients with large nodular goiters is unsatisfactory because it is ineffective. Furthermore, it is associated with adverse effects on bones and the cardiovascular system. Nonsurgical, minimally invasive treatment modalities such as percutaneous laser ablation (LA) and radiofrequency ablation (RFA) have been used to treat thyroid nodules. However no studies comparing LA and RFA have been published so far.

Aims of the study

1. To evaluate whether LA and RFA cause a reduction ≥50% in the volume of thyroid nodules after 6 months and 1 year follow-up
2. To evaluate whether the features of thyroid nodules as evaluated by thyroid ultrasound, contrast-enhanced ultrasound, power-doppler and core-biopsy influence LA and RFA outcomes
3. To evaluate changes in thyroid function and thyroid autoimmunity after LA and RFA.
4. To evaluate differences between LA and RFA in terms of complications, side effects and tolerability.

Patients will be recruited, treated and followed at Santa Maria Goretti Hospital in Latina, Italy, by physicians with expertise in LA and RFA. The scientific coordinator of this study is dr. Silvia Manfrini.

Laser Ablation Versus Radiofrequency Ablation for Thyroid Nodules

Prospective Randomized Comparative Study of the Effectiveness and Safety of Ultrasound-guided Laser and Radiofrequency Ablation for the Treatment of Benign Thyroid Nodules

Differences in the percentage of nodules with greater than 50% base volume reduction at 6 and 12 months

Basal volume in mL of the nodules will be calculated with the ellipsoid formula

% of amount of fibrosis and colloid components evaluated with score-biopsy

Variation in TSH value (mUI/ml) before and after LA and RFA

Variation in AbTPO and AbTg levels (UI/ml) before and after LA and RFA

Differences in the rate of complications and side effects between LA and RFA

Tolerability will be evaluated by McGill Pain Questionnaire, Melzack 1975, italian version

Quality of Life will be evaluated by SF-36 QoL questionnaire after 6 months and 1 year in both arms.

Campus Bio-Medico University

Medical Doctor

Carcinoma

Carcinoma, Papillary

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

Adjuvants, Anesthesia

Anticonvulsants

Antiemetics

Muscle Relaxants, Central

Psychotropic Drugs

Gastrointestinal Agents

Diazepam

Single session with standardized approach: Two fibers, up to 2 laser emissions; nodule volume up to 10 ml are treated by 800 Joules /ml and above 10 ml by 600 Joules/ml.The treatment is performed under local anesthesia and with diazepam sedation.

Thyroid nodule pathologies occur frequently and represent a clinical issue for the endocrinologists, surgeons, nuclear physicians as well as the general practitioners. The incidence of this pathology has been further highlighted by the introduction of the ultrasound examination into the clinical practice as 20% with impalpable thyroid nodules is now detected through ultrasound. The majority of nodules are benign and characterized by slow growth, and therefore treated with suppressive doses of levothyroxine. Long-term levothyroxine treatment has, however, several well-known side effects and limitations.

During the last years, number of controlled studies have demonstrated that ultrasound guided percutaneous laser treatment (PLA) is able to reach the target lesion within the thyroid with a high level of precision, and to destroy the thyroid tissue in a predictable and repeatable fashion, without side effects.

Aim of the study:

1. to assess 1-year and 3-year effect of laser ablation therapy on the volume of benign thyroid nodules and on nodule-related symptoms, and to compare these effects with findings in control group without active therapy;
2. to assess the eventual re-occurence of thyroid lesions (observed after other types of ablation treatment, like percutaneous ethanol injection) during a 3-year follow-up;
3. to demonstrate reproducibility of results within different environments and under different operators;
4. to validate eventual presence of major or minor side effects.

To this aim we shall randomized 200 patients either for PLA (100 pts) or standard follow-up. Patients will be recruited, treated and followed in 4 italian centers (Ospedale Regina Apostolorum - Roma, Arcispedale S. Maria Nuova - Reggio Emilia, Ospedale S. Maria della Misericordia - Perugia, Ospedale di Cisanello - Pisa) by physicians with experience in PLA.The scientific coordinator of this multicentre study is dr. Claudio Maurizio Pacella.

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
Laser Ablation Versus Radiofrequency Ablation for Thyroid Nodules	NCT02714946	Thyroid Nodule	Percutaneous La... Percutaneous Ra...	18 Years - 65 Years	Campus Bio-Medico University
Laser Ablation Versus Radiofrequency Ablation for Thyroid Nodules	NCT02714946	Thyroid Nodule	Percutaneous La... Percutaneous Ra...	18 Years - 65 Years	Campus Bio-Medico University
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
Percutaneous Laser Ablation in Benign Thyroid Nodules.Long Term Results	NCT00858104	Thyroid Nodule	Percutaneous La...	18 Years -	Elesta S.R.L.
Laser Ablation Versus Radiofrequency Ablation for Thyroid Nodules	NCT02714946	Thyroid Nodule	Percutaneous La... Percutaneous Ra...	18 Years - 65 Years	Campus Bio-Medico University
Percutaneous Laser Ablation in Benign Thyroid Nodules.Long Term Results	NCT00858104	Thyroid Nodule	Percutaneous La...	18 Years -	Elesta S.R.L.
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 percutaneous laser ablation