Multicentric Randomized Controlled Study of Percutaneous Laser Ablation Versus Follow Up in Benign Thyroid Nodules. Long Term Results
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 8
- Primary Endpoint
- Short- (1-year) and long- (3-year) term evolution of the thyroid nodules volume and symptoms after the treatment vs. simple clinical observation.(Strong Endpoint: %nodules with greater than 50% base volume reduction and %patients free of symptoms)
Study Overview
Brief Summary
Thyroid nodule pathologies occur frequently and represent a clinical issue for the endocrinologists, surgeons, nuclear physicians as well as the general practitioners. The incidence of this pathology has been further highlighted by the introduction of the ultrasound examination into the clinical practice as 20% with impalpable thyroid nodules is now detected through ultrasound. The majority of nodules are benign and characterized by slow growth, and therefore treated with suppressive doses of levothyroxine. Long-term levothyroxine treatment has, however, several well-known side effects and limitations.
During the last years, number of controlled studies have demonstrated that ultrasound guided percutaneous laser treatment (PLA) is able to reach the target lesion within the thyroid with a high level of precision, and to destroy the thyroid tissue in a predictable and repeatable fashion, without side effects.
Aim of the study:
- to assess 1-year and 3-year effect of laser ablation therapy on the volume of benign thyroid nodules and on nodule-related symptoms, and to compare these effects with findings in control group without active therapy;
- to assess the eventual re-occurence of thyroid lesions (observed after other types of ablation treatment, like percutaneous ethanol injection) during a 3-year follow-up;
- to demonstrate reproducibility of results within different environments and under different operators;
- to validate eventual presence of major or minor side effects.
To this aim we shall randomized 200 patients either for PLA (100 pts) or standard follow-up. Patients will be recruited, treated and followed in 4 italian centers (Ospedale Regina Apostolorum - Roma, Arcispedale S. Maria Nuova - Reggio Emilia, Ospedale S. Maria della Misericordia - Perugia, Ospedale di Cisanello - Pisa) by physicians with experience in PLA.The scientific coordinator of this multicentre study is dr. Claudio Maurizio Pacella.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The presence of a single nodule or dominating nodule;
- •A solid or mixed echo-structure with less than 20% fluid volume;
- •A lesion volume between 5 and 18 ml (greatest diameter > 3.0 cm and <= 4 cm);
- •Thyroid hormone and TSH serum levels within the normalcy value;
- •2 cytologically negative examinations for suspected neoplasia (British Thyroid Association, Second class THY)within the last six months;
- •Calcitonin values within the normalacy value;
- •Anticoagulant treatment suspension and antiaggregation treatment suspended for at least 72 hours.
Exclusion Criteria
- •Hyperfunctioning lesion (99mTc scintigraph);
- •Autoimmune thyreopathy or elevation of autoantibodies;
- •Active anticoagulant treatment or antiaggregation treatment.
Arms & Interventions
1
Laser thermal ablation
Intervention: Percutaneous Laser Ablation (Procedure)
2
Follow-up
Outcomes
Primary Outcomes
Short- (1-year) and long- (3-year) term evolution of the thyroid nodules volume and symptoms after the treatment vs. simple clinical observation.(Strong Endpoint: %nodules with greater than 50% base volume reduction and %patients free of symptoms)
Time Frame: 3 years
Secondary Outcomes
- Assessment of short-term and long-term PLA safety, tolerability and reproducibility.(3 years)