Percutaneous Laser Ablation in Benign Thyroid Nodules.Long Term Results

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2013-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Thyroid Nodule

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Laser thermal ablation

Group Type ACTIVE_COMPARATOR

Percutaneous Laser Ablation

Intervention Type PROCEDURE

Single session with standardized approach: Two fibers, up to 2 laser emissions; nodule volume up to 10 ml are treated by 800 Joules /ml and above 10 ml by 600 Joules/ml.The treatment is performed under local anesthesia and with diazepam sedation.

2

Follow-up

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Percutaneous Laser Ablation

Single session with standardized approach: Two fibers, up to 2 laser emissions; nodule volume up to 10 ml are treated by 800 Joules /ml and above 10 ml by 600 Joules/ml.The treatment is performed under local anesthesia and with diazepam sedation.

Intervention Type PROCEDURE

Other Intervention Names

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Arcispedale S. Maria Nuova is using commercially available system EchoLaser XVG (Integrated Ultrasound-Laser, Elesta, Italy). Other centers are using commercially available systems MyLab70XV (Ultrasound, Esaote, Italy) and Smart1064 BS (Nd:Yag Laser, DEKA, Italy). Disposable Fiber Optic devices : Bare Fiber PLA THY 2111, Bare Fiber PLA S (Asclepion Laser Technologies GmbH, Germany).

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No