Laser Ablation Versus Radiofrequency Ablation for Thyroid Nodules (LARA)

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Thyroid Nodule	Device: Percutaneous Laser Ablation; Device: Percutaneous Radiofrequency Ablation	Not Applicable

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Prospective Randomized Comparative Study of the Effectiveness and Safety of Ultrasound-guided Laser and Radiofrequency Ablation for the Treatment of Benign Thyroid Nodules
Study Start Date :	January 2016
Estimated Primary Completion Date :	January 2018
Estimated Study Completion Date :	January 2019

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: LA Arm; Percutaneous Laser Ablation	Device: Percutaneous Laser Ablation; 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.
Active Comparator: RFA Arm; Percutaneous Radiofrequency Ablation	Device: Percutaneous Radiofrequency 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

Outcome Measures

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Primary Outcome Measures :

1. Percentage of thyroid nodules with volume reduction at 6 and 12 months after treatment [ Time Frame: 12 months ]
   Differences in the percentage of nodules with greater than 50% base volume reduction at 6 and 12 months

Secondary Outcome Measures :

1. Basal Volume of Thyroid Nodules as Predictive factor of response to treatment [ Time Frame: 12 months ]
   Basal volume in mL of the nodules will be calculated with the ellipsoid formula
2. Histopathological features of Thyroid Nodules as Predictive factor of response to treatment [ Time Frame: 12 months ]
   % of amount of fibrosis and colloid components evaluated with score-biopsy
3. Variation in TSH levels after treatment [ Time Frame: 12 months ]
   Variation in TSH value (mUI/ml) before and after LA and RFA
4. Variation in AbTPO and AbTg levels after treatment [ Time Frame: 12 months ]
   Variation in AbTPO and AbTg levels (UI/ml) before and after LA and RFA
5. Complications [ Time Frame: Up to 1 year follow-up ]
   Differences in the rate of complications and side effects between LA and RFA
6. Tolerability evaluated by McGill Pain Questionnaire [ Time Frame: 0 and 6 months ]
   Tolerability will be evaluated by McGill Pain Questionnaire, Melzack 1975, italian version
7. Quality of Life [ Time Frame: 6 months and 1 year ]
   Quality of Life will be evaluated by SF-36 QoL questionnaire after 6 months and 1 year in both arms.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Solitary thyroid nodule or dominating nodule which is well-identifiable in multinodular goiter.
• Compressive and /or cosmetic symptoms caused by thyroid nodule or increase in nodule volume >20% in 1 year even without symptoms
• A nodule volume between 10 and 90 ml
• Solid nodule (uniformly compact or nearly completely solid, with a liquid component not exceeding 30%);
• Two thyroid biopsies resulted negative for malignancy
• Calcitonin levels within normal ranges

Exclusion Criteria:

• Hyperfunctioning lesion as evaluated biochemically and/or by 99mTc scintigraphy
• Pregnancy

Contacts and Locations

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Contacts

Contact: Silvia Manfrini, MD	003906225411297	s.manfrini@unicampus.it
Contact: Angelo Lauria	00390622541692	a.lauria@unicampus.it

Locations

Italy
Santa Maria Goretti Hospital	Recruiting
Latina, Italy, 04100
Contact: Roberto Cianni, MD 003907736553659 roberto.cianni@fastweb.it
Contact: Roberto Cesareo, MD 0039333 6791066 robertocesareo@libero.it

Sponsors and Collaborators

Campus Bio-Medico University

Investigators

Principal Investigator:	Roberto Cianni	Santa Maria Goretti Hospital

More Information

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Publications:

Gharib H, Papini E, Paschke R, Duick DS, Valcavi R, Hegedüs L, Vitti P; AACE/AME/ETA Task Force on Thyroid Nodules. American Association of Clinical Endocrinologists, Associazione Medici Endocrinologi, and European Thyroid Association medical guidelines for clinical practice for the diagnosis and management of thyroid nodules: executive summary of recommendations. J Endocrinol Invest. 2010;33(5 Suppl):51-6.

Pacella CM, Bizzarri G, Guglielmi R, Anelli V, Bianchini A, Crescenzi A, Pacella S, Papini E. Thyroid tissue: US-guided percutaneous interstitial laser ablation-a feasibility study. Radiology. 2000 Dec;217(3):673-7.

Ahmed M, Brace CL, Lee FT Jr, Goldberg SN. Principles of and advances in percutaneous ablation. Radiology. 2011 Feb;258(2):351-69. doi: 10.1148/radiol.10081634. Review.

Papini E, Guglielmi R, Bizzarri G, Graziano F, Bianchini A, Brufani C, Pacella S, Valle D, Pacella CM. Treatment of benign cold thyroid nodules: a randomized clinical trial of percutaneous laser ablation versus levothyroxine therapy or follow-up. Thyroid. 2007 Mar;17(3):229-35.

Cesareo R, Pasqualini V, Simeoni C, Sacchi M, Saralli E, Campagna G, Cianni R. Prospective study of effectiveness of ultrasound-guided radiofrequency ablation versus control group in patients affected by benign thyroid nodules. J Clin Endocrinol Metab. 2015 Feb;100(2):460-6. doi: 10.1210/jc.2014-2186. Epub 2014 Nov 11.

Responsible Party:	Dr. Silvia Manfrini, Medical Doctor, Campus Bio-Medico University
ClinicalTrials.gov Identifier:	NCT02714946 History of Changes
Other Study ID Numbers:	Studio 96-15 CE 93321
First Posted:	March 22, 2016
Last Update Posted:	March 22, 2016
Last Verified:	March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Dr. Silvia Manfrini, Campus Bio-Medico University:

Thyroid Nodule; Percutaneous radiofrequency ablation (RFA); Percutaneous laser ablation (LA)

Additional relevant MeSH terms:

Thyroid Diseases; Thyroid Nodule; Endocrine System Diseases; Thyroid Neoplasms	Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms