Clinical trial NCT02714946: Laser Ablation Versus Radiofrequency Ablation for Thyroid Nodules
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Nodule
Keywords: Thyroid Nodule
Percutaneous radiofrequency ablation (RFA)
Percutaneous laser ablation (LA)
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2016-03-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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 ≥ 5 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

Primary outcomes:
measure: Percentage of thyroid nodules with volume reduction at 6 and 12 months after treatment
timeFrame: 12 months
Secondary outcomes:
measure: Basal Volume of Thyroid Nodules as Predictive factor of response to treatment
timeFrame: 12 months
measure: Histopathological features of Thyroid Nodules as Predictive factor of response to treatment
timeFrame: 12 months
measure: Variation in TSH levels after treatment
timeFrame: 12 months
measure: Variation in AbTPO and AbTg levels after treatment
timeFrame: 12 months
measure: Complications
timeFrame: Up to 1 year follow-up
measure: Tolerability evaluated by McGill Pain Questionnaire
timeFrame: 0 and 6 months
measure: Quality of Life
timeFrame: 6 months and 1 year
Other outcomes:
Locations:
city: Latina
country: Italy
facility: Santa Maria Goretti Hospital
Study officials:
affiliation: Santa Maria Goretti Hospital
name: Roberto Cianni
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gharib H, Papini E, Paschke R, Duick DS, Valcavi R, Hegedus 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.
citation: 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. doi: 10.1148/radiology.217.3.r00dc09673.
citation: 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.
citation: 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. doi: 10.1089/thy.2006.0204.
citation: 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.