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Why remove the thyroid gland in order to eliminate the symptoms of benign nodules?

modi-lite

ModiLite is a micro-invasive ultrasound-guided treatment that uses the heat generated by a laser source to destroy portions of nodular tissue, causing a progressive reduction in the thyroid nodule volume and subsequent disappearance of the compressive and aesthetic symptoms of the neck.

Thanks to micro-invasive access with very thin needles inserted into optical fibres, ModìLite allows for destroying the neoplastic tissue, thus avoiding the trauma caused by surgical access, with evident advantages such as no or much less post-op pain, no or very brief hospitalization, and an almost immediate return to social life.

Who can be treated in this way?

ModiLite is indicated for subjects with one or more benign solid thyroid nodules with a volume capable of causing cosmetic damage or symptoms of local compression, or those who prefer not to undergo surgery. ModìLite is also a safe and effective treatment for subjects who are not able to undergo surgery for critical medical reasons.

Treatment guide

One or two optical fibres are inserted via ultrasound guidance into the nodule through extremely fine
Gauge needles. It’s an outpatient procedure that does not require local anaesthesia (optional at the discretion of the physician). The treatment session lasts from 10 to 20 minutes, which is the time required for the heat inside the nodule to destroy the treated tissue. There are no incisions or stitches and the entire session, including the preparation time, takes just on 30 minutes. Recovery time are short and you can return to your normal activities the very next day after treatment. The effectiveness of ModìLite allows for obtaining good results in one single session.
During the following months you will just need to carry out follow-ups of the thyroid function and ultrasounds to evaluate the reduction of the volume of the nodule.

Contrary to minimally invasive surgical thyroid techniques and thermal ablation with radiofrequency, ModìLite is the mini-invasive treatment par excellence: thanks to the access with very fine needles (with a caliber less than 1 mm) and 300micron fiber optic ModìLite is defined micro-invasive treatment.

1./2. LA332 Esaote probe with dedicated multi-fibre Guiding System
3. Biopsy Software related to multi-fibre Guiding System / 4.Planning Software

The benefits of ModiLite

  • It significantly reduces the compressive and cosmetic symptoms
  • It does not leave any marks on the neck (no scarring)
  • It has a short duration (about 30 minutes – including preparation of the patient)
  • It is performed in the Day Hospital
  • Short recovery time
  • The use of fine and painless needles that respects the neck structures
  • It does not require general or local anaesthesia (local anaesthesia optional at the discretion of the physician)
  • It produces a highly predictable and repeatable coagulation volume as required by small organs surrounded by critical vital structures
  • It does not require life-long drug therapy as with surgical removal
  • It does not compromise further therapeutic action

Knowledge

Thyroid nodules

Thyroid nodules are very common, especially in women and as they get older. In fact, according to some estimations about 50% of the population develop thyroids nodule in their lifetime, which are asymptomatic and very often never detected. The vast majority of thyroid nodules are not malignant and do not cause any alterations to the thyroid function. If you belong to that group of people who develop a benign nodule large enough to cause compressive symptoms (trouble swallowing, pain when moving the neck, deviation of the trachea) and to alter the appearance of the neck, ModiLite can offer you a new and effective therapeutic option.

nodulo_tiroideo

Besides drug therapy that had no effect in reducing the volume of the thyroid nodule, for many years the surgical solution was the only therapeutic option for symptomatic benign nodules.

Surgical removal (thyroidectomy) consists of removal of the entire gland and is in some cases an excessive action which, together with the nodule, also removes healthy glandular tissue that is still able to produce the hormones necessary for the body, forcing life-long hormonal therapy on the patient.

What is thyroid nodule disease?

The thyroid nodule is one of the most common diseases of the thyroid, the butterfly-shaped endocrine gland located in our throat, which through the two hormones produced – thyroxine (T-4) and triiodothyronine (T-3) – regulates numerous physiological functions, including our metabolism. Thyroid problems, quite common in women, are more frequent in areas low in iodine. This is the reason why doctors recommend holidays by the sea at early age if possible, as it is rich in this substance that should not be lacking in our diet. Thyroid nodules – also called nodular goitre – can also affect children and young people, but they are more frequent in women aged between 50 and 60.

The thyroid nodule is a rounded tumefaction that can be either single or multiple, in which case we are talking about multi-nodular goitre, one of the most common diseases of this butterfly-shaped endocrine gland (the thyroid). The nodules may be solid, cystic (containing liquid) or mixed. They are generally small, so in many cases a thyroid nodule is entirely asymptomatic and only discovered by chance, but it can also measure several centimetres and cause compression problems with alterations to the appearance of the neck.

ModiLite currently offers excellent efficacy in reducing predominantly symptomatic solid or mixed benign nodules.

Clinical cases

Clinical Case no.1

Benign Thyroid Nodule

A patient with a solid isoechoic nodule (volume 20ml) in the right thyroid lobe, underwent Laser Thermotherapy. During the treatment no discomfort was reported by the patient.

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CEUS image after the treatment showing the hypoechoic zone of the coagulation area

The ultrasound scan at the two-year follow-up showed a reduction in the nodule volume equal to 70% compared to the basal volume.

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US images before the treatment and two-year follow-up showing the reduction of the nodule

Images by courtesy of Dr. Rago (Cisanello Hospital, Pisa)

Clinical Case no.2

Metastatic Lymph nodes in the neck

Patient with metastatic lymph node from papillary thyroid carcinoma has been treated with Laser Thermotherapy with two fibres.

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CEUS image showing the high absorption of the contrast of the pathological lymph node

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US image showing two fibres inside the lymph node

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CEUS image showing the absence of enhancement after the treatment

Images by courtesy of Dr. Giovanni Mauri (IEO Hospital, Milan)

FAQ

FAQ – Your frequently asked questions, here you can find answers.

Why should I consider undergoing ModìLite to treat my nodule?

ModìLite is indicated in the treatment of solid or mixed benign symptomatic nodules with a repeated cytological diagnosis of benignity.

How is the ModìLite treatment performed?

One or two optical fibres are inserted via ultrasound guidance into the nodule through extremely fine
Gauge needles. ModìLite is based on EchoLaser system that integrates the most advanced treatment planning technologies with a special multisource laser system. The treatment session lasts from 10 to 20 minutes, which is the time required for the heat inside the nodule to destroy the treated tissue. There are no incisions or stitches and the entire session, including the preparation time, takes just on 30 minutes.

Do I have to have an anaesthetic?

Thanks to the extremely find needles ModìLite is a procedure that does not require either a general or local anaesthetic. At times patients report slight discomfort when the needles are inserted and a mild sensation of heat during the treatment. If you like, you can still have a local anaesthetic but bear in mind that if you maintain the sensitivity of your neck and cooperate with the physician this will increase the safety and ensure correct performance of the treatment.

What are the recovery times?

You can return to your normal activities the very next day after treatment. During the following months you will just need to carry out follow-ups of the thyroid function and ultrasounds to evaluate the reduction of the volume of the nodule.

How many sessions will I need?

The effectiveness of ModìLite allows for obtaining good results in one single session. If necessary, the treatment can be repeated without compromising any further therapeutic treatment should this be required.

What kind of results can I expect?

ModìLite gives rise to the disappearance, or in any case the reduction, of the local systems due to the compression exerted by the nodule on the surrounding structures, thus ensuring a substantial recovery of your quality of life. With protruding nodules the normal morphology of your neck will be restored with obvious aesthetic benefits. The reduction process of the nodule, which occurs thanks to the body’s natural cellular repair mechanisms, takes a couple of months.

Has ModìLite been clinically tested?

Clinical trials* have demonstrated that after a single treatment, ModìLite causes a 50% reduction of the nodular volume in the great majority of patients and that this reduction remains stable over time. Complications have been extremely rare and only of a transient nature.

*Long-term Efficacy of Ultrasound-guided Laser Ablation for Benign Solid Thyroid Nodules. Results of a Three-year Multicenter Prospective Randomized Trial – JCEM July 2014

Why should I choose ModìLite over other ablative techniques?

Because its effectiveness has been widely demonstrated after a long period of experimentation and in clinical practice its benefits have been evaluated over the years. It is estimated that since being launched, there have been approximately 4.000 patients treated in Italy with a 10-year follow-up.

Publications

Benign Thyroid Nodule

A comparison of laser with radiofrequency ablation for the treatment of benign thyroid nodules: a propensity score matching analysis. 
Pacella CM et al
Int J Hyperthermia. 2017 Jun 12:1-9.

Percutaneous laser ablation for benign thyroid nodules: a meta-analysis. 
Sui WF, Li JY, Fu JH.
Oncotarget. 2017 May 17.

Laser ablation is more effective for spongiform than solid thyroid nodules. A 4-year retrospective follow-up study.
Negro R, Salemb TM and Greco G. 
Int J Hyperthermia. 2016 Nov;32(7):822-8.

Benign thyroid nodules treatment using percutaneous laser ablation (PLA) and radiofrequency ablation (RFA).
Mauri G, Cova L, Monaco CG, Sconfienza LM, Corbetta S, Benedini S, Ambrogi F, Milani V, Baroli A, Ierace T& Solbiati L
Int J Hyperthermia. 2016 Nov 15:1-5.

Detection of the Single-Session Complete Ablation Rate by Contrast-Enhanced Ultrasound during Ultrasound-Guided Laser Ablation for Benign Thyroid Nodules: A Prospective Study 
Shuhua Ma, Ping Zhou, XiaominWu, Shuangming Tian, and Yongfeng Zhao 
BioMed Research International Volume 2016 (2016), Article ID 9565364, 8 pages

AACE/AME/ETA Thyroid Nodule Guidelines 
Gharib H, Papini E, Garber JR, Duick DS, Harrel RM, Hegedüs L, Paschke R, Valcavi R, Vitti P
Endocr Pract. 2016;22 (Suppl 1)

Outcomes and Risk Factors for Complications of Laser Ablation for Thyroid Nodules. A Multicenter Study on 1531 Patients.
Pacella CM, Mauri G, Achille G, Barbaro D, Bizzarri G, De Feo P, Di Stasio E, Esposito R, Gambelunghe G, Misischi I, Raggiunti B, Rago T, Patelli GL, D’Este S, Vitti P, Papini E.
J Clin Endocrinol Metab. 2015 Oct;100(10):3903-10.

Ultrasound-guided percutaneous laser ablation (LA) in treating symptomatic solid benign thyroid nodules: Our experience in 45 patients.
Achille G, Zizzi S, Di Stasio E, Grammatica A, Grammatica L.
Head Neck. 2014 Dec 18.

Thyroid nodule morphology affects the efficacy of ultrasound-guided interstitial laser ablation: A nested case-control study. 
Gambelunghe G, Bini V, Stefanetti E, Colella R, Monacelli M, Avenia N, De Feo P. 
Int J Hyperthermia. 2014 Oct 7:1-4

Long-term Efficacy of Ultrasound-Guided Laser Ablation for Benign Solid Thyroid Nodules. Results of a Three-Year Multicenter Prospective Randomized Trial. 
Papini E, Rago T, Gambelunghe G, Valcavi R, Bizzarri G, Vitti P, De Feo P, Riganti F, Misischi I, Di Stasio E, Pacella CM. 
J Clin Endocrinol Metab. 2014 Oct;99(10)

Laser ablation and 131-iodine: a 24-month pilot study of combined treatment for large toxic nodular goiter.
Chianelli M, Bizzarri G, Todino V, Misischi I, Bianchini A, Graziano F, Guglielmi R, Pacella CM, Gharib H, Papini E. 
J Clin Endocrinol Metab. 2014 Jul;99(7)

Diagnosis of endocrine disease: thyroid ultrasound (US) and US-assisted procedures: from the shadows into an array of applications. 
Papini E, Pacella CM, Hegedus L. 
Eur J Endocrinol. 2014 Mar 14;170(4):R133-46

Clinical review: Nonsurgical, image-guided, minimally invasive therapy for thyroid nodules. 
Gharib H, Hegedüs L, Pacella CM, Baek JH, Papini E 
J Clin Endocrinol Metab. 2013 Oct;98(10):3949-57.

Image-guided percutaneous ablation therapies for local recurrences of thyroid nodule.
Pacella CM and Papini E 
J.Endocrinol.Invest.36: 61-70;2013

The administration of anesthetic in the thyroid pericapsular region increases the possibility of side effects during percutaneous laser photocoagulation of thyroid nodules.
Gambelunghe G, Bini V, Monacelli M, Avenia N, D’Ajello M, Colella R, De Feo P 
Lasers Surg Med. 2013

Ultrasound-Guided Interstitial Laser Ablation for Thyroid Nodules Is Effective Only at High Total Amounts of Energy: Results From a Three-Year Pilot Study.
Gambelunghe G, Fede R, Bini V, Monacelli M, Avenia N, D’Ajello M, Colella R, Nasini G, De Feo P
Surg Innov. 2012

Percutaneous Laser Ablation of Cold Benign Thyroid Nodules: A 3-Year Follow-Up Study in 122 Patients. 
Valcavi R,Riganti F,Bertani A,Formisano D, Pacella CM
Thyroid 2010; Volume 20, Number 11

Laser and Radiofrequency Ablation procedures. 
Valcavi R, Bertani A, Pesenti , Al Jandali, Frasoldati, Formisano, Pacella CM.
Thyroid Ultrasound and Ultrasound-Guided FNA
Springer

Treatment of Benign Cold Thyroid Nodules: A Randomized Clinical Trial of Percutaneous Laser Ablation Versus Levothyroxine Therapy or Follow-up 
Papini E, Guglielmi R, Bizzarri G, Graziano F, Bianchini A, Brufani C, Pacella S, Valle D, Pacella CM.
Thyroid. 2007 Mar;17(3):229-35.

Thyroid Tissue: US-guided Percutaneous Interstitial Laser Ablation—A Feasibility Study. 
Pacella CM, Bizzarri G, Guglielmi R, Anelli V, Bianchini A, Crescenzi A, Pacella S, Papini E.
Radiology. 2000 Dec;217(3):673-7

Metastatic Lymph Node in the neck

Role of ultrasound in the assessment of percutaneous laser ablation of cervical metastatic lymph nodes from thyroid carcinoma.
Zhang L, Zhou W, Zhan W.
Acta Radiol. 2017 Jan 1:284185117721261.

Percutaneous laser ablation for treatment of locally recurrent papillary thyroid carcinoma <15 mm 
Zhou W, Zhang L, Zhan W, Jiang S, Zhu Y, Xu S.
Clin Radiol 2016 Dec;71(12):1233-1239.

Treatment of Metastatic Lymph Nodes in the Neck from Papillary Thyroid Carcinoma with Percutaneous Laser Ablation.
Mauri G, Cova L, Ierace T, Baroli A, Di Mauro E, Pacella CM, Goldberg SN, Solbiati L 
Cardiovasc Intervent Radiol. 2016 Jul;39(7):1023-30

Percutaneous Laser Ablation of Metastatic Lymph Nodes in the Neck from Papillary thyroid carcinoma: preliminary results.
Mauri G, Cova L, Tondolo T, Ierace T, Baroli A, Di Mauro E, Pacella CM, Goldberg SN, Solbiati L 
J Clin Endocrinol Metab. 2013 May 10.

Percutaneous ultrasound-guided laser ablation is effective for treating selected nodal metastases in papillary thyroid cancer.
Papini E, Bizzarri G, Bianchini A, Valle D, Misischi I, Guglielmi R, Salvatori M, Solbiati L, Crescenzi A, Pacella CM, Gharib H.
J Clin Endocrin Metab, 2013 Jan;98(1):E92-7

Clinical Trials

Multicentric Randomized Controlled Study of Percutaneous Laser Ablation Versus Follow Up in Benign Thyroid Nodules. Long Term Results

Multicentre Randomized Clinical Trial
No. of patients enrolled: 200
Reference Study Centres: 4, Azienda Ospedaliero-Universitaria di Pisa – Presidio di Cisanello, Ospedale Regina Apostolorum, Azienda Ospedaliera di Perugia, Arcispedale Santa Maria Nuova
Study status: Completed
Registered on ClinicalTrial.gov: https://clinicaltrials.gov/ct2/show/NCT00858104
Publications of the results: Long-term Efficacy of Ultrasound-Guided Laser Ablation for Benign Solid Thyroid Nodules. Results of a Three-Year Multicenter Prospective Randomized Trial, Papini E, Rago T, Gambelunghe G, Valcavi R, Bizzarri G, Vitti P, De Feo P, Riganti F, Misischi I, Di Stasio E, Pacella CM. J Clin Endocrinol Metab. 2014 Oct

Laser Ablation Versus Radiofrequency Ablation for Thyroid Nodules (LARA)

Randomised Clinical Trial
No. of patients enrolled: 60
Reference Study Centre: Ospedale, Santa Maria Goretti, Latina
Study status: enrolment of patient
Registered on ClinicalTrial.gov: https://clinicaltrials.gov/ct2/show/NCT02714946?term=laser+versus+radiofrequency+thyroid&rank=1

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