Percutaneous Laser Ablation in Benign Thyroid Nodules.Long Term Results

E

Elesta

Status and phase

Completed
Phase 4

Conditions

Thyroid Nodule

Treatments

Procedure: Percutaneous Laser Ablation

Study type

Interventional

Funder types

Industry

Identifiers

NCT00858104
IALT-07

Details and patient eligibility

About

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: 1. 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; 2. 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; 3. to demonstrate reproducibility of results within different environments and under different operators; 4. 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.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

1
Active Comparator group
Description:
Laser thermal ablation
Treatment:
Procedure: Percutaneous Laser Ablation
2
No Intervention group
Description:
Follow-up

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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