Laser Ablation Versus Radiofrequency Ablation for Thyroid Nodules

Not Applicable

• Conditions: Thyroid Nodule
• Interventions: Device: Percutaneous Radiofrequency Ablation; Device: Percutaneous Laser Ablation

• Registration Number: NCT02714946
• Lead Sponsor: Campus Bio-Medico University

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-02-19
• Study First Submitted QC: 2016-03-16
• Study First Posted: 2016-03-22
• Status Verified: 2019-09
• Primary Completion: 2019-09
• Last Update Submitted: 2019-09-02
• Last Update Posted: 2019-09-04
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RFA Arm	Percutaneous Radiofrequency Ablation	Percutaneous Radiofrequency Ablation
LA Arm	Percutaneous Laser Ablation	Percutaneous Laser Ablation

Primary Outcome Measures

Name	Time	Method
Percentage of thyroid nodules with volume reduction at 6 and 12 months after treatment	12 months	Differences in the percentage of nodules with greater than 50% base volume reduction at 6 and 12 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Santa Maria Goretti Hospital; 🇮🇹 Latina, Italy