Laser Ablation Versus Radiofrequency Ablation for Thyroid Nodules

Thyroid Nodule Clinical Trial

— LARA  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02714946
• Other study ID #: Studio 96-15 CE 93321
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2016
• Est. completion date: January 2020

Study information

• Verified date: September 2019
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: January 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Nodule

Intervention

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.
• 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

Locations

Country	Name	City	State
Italy	Santa Maria Goretti Hospital	Latina

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View 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. — View Citation

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of thyroid nodules with volume reduction at 6 and 12 months after treatment	Differences in the percentage of nodules with greater than 50% base volume reduction at 6 and 12 months	12 months
Secondary	Basal Volume of Thyroid Nodules as Predictive factor of response to treatment	Basal volume in mL of the nodules will be calculated with the ellipsoid formula	12 months
Secondary	Histopathological features of Thyroid Nodules as Predictive factor of response to treatment	% of amount of fibrosis and colloid components evaluated with score-biopsy	12 months
Secondary	Variation in TSH levels after treatment	Variation in TSH value (mUI/ml) before and after LA and RFA	12 months
Secondary	Variation in AbTPO and AbTg levels after treatment	Variation in AbTPO and AbTg levels (UI/ml) before and after LA and RFA	12 months
Secondary	Complications	Differences in the rate of complications and side effects between LA and RFA	Up to 1 year follow-up
Secondary	Tolerability evaluated by McGill Pain Questionnaire	Tolerability will be evaluated by McGill Pain Questionnaire, Melzack 1975, italian version	0 and 6 months
Secondary	Quality of Life	Quality of Life will be evaluated by SF-36 QoL questionnaire after 6 months and 1 year in both arms.	6 months and 1 year