Percutaneous Laser Ablation in Benign Thyroid Nodules.Long Term Results

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elesta S.R.L.
ClinicalTrials.gov Identifier:
NCT00858104
First received: March 6, 2009
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Thyroid Nodule
Procedure: Percutaneous Laser Ablation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicentric Randomized Controlled Study of Percutaneous Laser Ablation Versus Follow Up in Benign Thyroid Nodules. Long Term Results

Resource links provided by NLM:


Further study details as provided by Elesta S.R.L.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assessment of short-term and long-term PLA safety, tolerability and reproducibility. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: November 2008
Study Completion Date: May 2013
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Laser thermal ablation
Procedure: 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.
Other Names:
  • 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).
No Intervention: 2
Follow-up

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00858104

Locations
Italy
Ospedale Regina Apostolorum
Albano Laziale, Roma, Italy, 00041
Azienda Ospedaliera di Perugia - Osp. S.Maria della Misericordia
Perugia, Italy, 06126
Azienda Ospedaliero-Universitaria di Pisa - Presidio di Cisanello
Pisa, Italy, 56124
Arcispedale S. Maria Nuova
Reggio Emilia, Italy, 42100
Sponsors and Collaborators
Elesta S.R.L.
  More Information

Publications:
Responsible Party: Elesta S.R.L.
ClinicalTrials.gov Identifier: NCT00858104     History of Changes
Other Study ID Numbers: IALT-07
Study First Received: March 6, 2009
Last Updated: May 23, 2014
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Nodule
Endocrine System Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on July 26, 2014