Laser Ablation Versus Radiofrequency Ablation for Thyroid Nodules (LARA)

Campus Bio-Medico University of Rome

Status: Unknown

Conditions: Thyroid Nodule

Treatments: Device: Percutaneous Radiofrequency Ablation; Device: Percutaneous Laser Ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT02714946

Studio 96-15 CE 93321

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

LA Arm

Active Comparator group

Description:

Percutaneous Laser Ablation

Treatment:

Device: Percutaneous Laser Ablation

RFA Arm

Active Comparator group

Description:

Percutaneous Radiofrequency Ablation

Treatment:

Device: Percutaneous Radiofrequency Ablation