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Thyroid NoduleLARANCT02714946

Laser Ablation Versus Radiofrequency Ablation for Thyroid Nodules

A study testing Percutaneous Laser Ablation and Percutaneous Radiofrequency Ablation in people with Thyroid Nodule, run by Campus Bio-Medico University at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Thyroid Nodule
What is being tested?
Percutaneous Laser Ablation and Percutaneous Radiofrequency Ablation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteItaly
Study dates
Jan 2016to Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Hyperfunctioning lesion as evaluated biochemically and/or by 99mTc scintigraphy
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Santa Maria Goretti Hospital

    Latina, 04100

Other trials in Italy

About this study

Official title: Prospective Randomized Comparative Study of the Effectiveness and Safety of Ultrasound-guided Laser and Radiofrequency Ablation for the Treatment of Benign Thyroid Nodules

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.

Read the detailed 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.

Conditions
Thyroid Nodule
Being tested
Percutaneous Laser Ablation, Percutaneous Radiofrequency Ablation
Keywords
Thyroid Nodule, Percutaneous radiofrequency ablation (RFA), Percutaneous laser ablation (LA)
Medical subject headings
Thyroid Nodule

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous Laser AblationDevice

    Single session with standardized approach: One or two fibers will be used for treatments including one to three illuminations with a fixed output power of 3 W, using the pullback technique. Energy for each emission will be 1200-1800J based on nodule volume. The treatment is performed under local anesthesia and conscious sedation.

  • Percutaneous Radiofrequency AblationDevice

    Single session with standardized approach: A radiofrequency generator and a 17-gauge, 15-cm electrode with a 1-cm active tip will be used. A transisthmic approach along the short axis of the nodule will be used and the nodules will be managed with the moving-shot technique. 60 W of radiofrequency outpower will be used for all nodules. The treatment is performed under local anesthesia and conscious sedation

Study groups in NCT02714946
Study groupRoleWhat they receive
LA ArmActive comparatorPercutaneous Laser Ablation
Receives: Device: Percutaneous Laser Ablation
RFA ArmActive comparatorPercutaneous Radiofrequency Ablation
Receives: Device: Percutaneous Radiofrequency Ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of thyroid nodules with volume reduction at 6 and 12 months after treatment

    Differences in the percentage of nodules with greater than 50% base volume reduction at 6 and 12 months

    Measured: 12 months

Secondary outcomes (7)

  1. Basal Volume of Thyroid Nodules as Predictive factor of response to treatment

    Basal volume in mL of the nodules will be calculated with the ellipsoid formula

    Measured: 12 months

  2. Histopathological features of Thyroid Nodules as Predictive factor of response to treatment

    % of amount of fibrosis and colloid components evaluated with score-biopsy

    Measured: 12 months

  3. Variation in TSH levels after treatment

    Variation in TSH value (mUI/ml) before and after LA and RFA

    Measured: 12 months

  4. Variation in AbTPO and AbTg levels after treatment

    Variation in AbTPO and AbTg levels (UI/ml) before and after LA and RFA

    Measured: 12 months

  5. Complications

    Differences in the rate of complications and side effects between LA and RFA

    Measured: Up to 1 year follow-up

  6. Tolerability evaluated by McGill Pain Questionnaire

    Tolerability will be evaluated by McGill Pain Questionnaire, Melzack 1975, italian version

    Measured: 0 and 6 months

  7. Quality of Life

    Quality of Life will be evaluated by SF-36 QoL questionnaire after 6 months and 1 year in both arms.

    Measured: 6 months and 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionSep 2019 (estimated)
  4. Study completionJan 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02714946
Sponsor's protocol ID
Studio 96-15 CE 93321
Acronym
LARA
Status last verified
Sep 2019
First submitted
19 Feb 2016
Last updated
4 Sep 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Gharib H, Papini E, Paschke R, Duick DS, Valcavi R, Hegedus L, Vitti P; AACE/AME/ETA Task Force on Thyroid Nodules. American Association of Clinical Endocrinologists, Associazione Medici Endocrinologi, and European Thyroid Association medical guidelines for clinical practice for the diagnosis and management of thyroid nodules: executive summary of recommendations. J Endocrinol Invest. 2010;33(5 Suppl):51-6.

    PubMed 20543551

  • Pacella CM, Bizzarri G, Guglielmi R, Anelli V, Bianchini A, Crescenzi A, Pacella S, Papini E. Thyroid tissue: US-guided percutaneous interstitial laser ablation-a feasibility study. Radiology. 2000 Dec;217(3):673-7. doi: 10.1148/radiology.217.3.r00dc09673.

    PubMed 11110927

  • Ahmed M, Brace CL, Lee FT Jr, Goldberg SN. Principles of and advances in percutaneous ablation. Radiology. 2011 Feb;258(2):351-69. doi: 10.1148/radiol.10081634.

    PubMed 21273519

  • Papini E, Guglielmi R, Bizzarri G, Graziano F, Bianchini A, Brufani C, Pacella S, Valle D, Pacella CM. Treatment of benign cold thyroid nodules: a randomized clinical trial of percutaneous laser ablation versus levothyroxine therapy or follow-up. Thyroid. 2007 Mar;17(3):229-35. doi: 10.1089/thy.2006.0204.

    PubMed 17381356

  • Cesareo R, Pasqualini V, Simeoni C, Sacchi M, Saralli E, Campagna G, Cianni R. Prospective study of effectiveness of ultrasound-guided radiofrequency ablation versus control group in patients affected by benign thyroid nodules. J Clin Endocrinol Metab. 2015 Feb;100(2):460-6. doi: 10.1210/jc.2014-2186. Epub 2014 Nov 11.

    PubMed 25387256

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous Laser Ablation and Percutaneous Radiofrequency Ablation in people with Thyroid Nodule, run by Campus Bio-Medico University at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of thyroid nodules with volume reduction at 6 and 12 months after treatment (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02714946, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019.

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