Laser Ablation Versus Radiofrequency Ablation for Thyroid Nodules (LARA)

September 2, 2019 updated by: Dr. Silvia Manfrini, Campus Bio-Medico University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Latina, Italy, 04100
        • Santa Maria Goretti Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: LA Arm
Percutaneous Laser Ablation
Device: Percutaneous Laser Ablation
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.
Active Comparator: RFA Arm
Percutaneous Radiofrequency Ablation
Device: Percutaneous Radiofrequency Ablation
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of thyroid nodules with volume reduction at 6 and 12 months after treatment
Time Frame: 12 months
Differences in the percentage of nodules with greater than 50% base volume reduction at 6 and 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Basal Volume of Thyroid Nodules as Predictive factor of response to treatment
Time Frame: 12 months
Basal volume in mL of the nodules will be calculated with the ellipsoid formula
12 months
Histopathological features of Thyroid Nodules as Predictive factor of response to treatment
Time Frame: 12 months
% of amount of fibrosis and colloid components evaluated with score-biopsy
12 months
Variation in TSH levels after treatment
Time Frame: 12 months
Variation in TSH value (mUI/ml) before and after LA and RFA
12 months
Variation in AbTPO and AbTg levels after treatment
Time Frame: 12 months
Variation in AbTPO and AbTg levels (UI/ml) before and after LA and RFA
12 months
Complications
Time Frame: Up to 1 year follow-up
Differences in the rate of complications and side effects between LA and RFA
Up to 1 year follow-up
Tolerability evaluated by McGill Pain Questionnaire
Time Frame: 0 and 6 months
Tolerability will be evaluated by McGill Pain Questionnaire, Melzack 1975, italian version
0 and 6 months
Quality of Life
Time Frame: 6 months and 1 year
Quality of Life will be evaluated by SF-36 QoL questionnaire after 6 months and 1 year in both arms.
6 months and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Campus Bio-Medico University

Investigators

  • Principal Investigator: Roberto Cianni, Santa Maria Goretti Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

February 19, 2016

First Submitted That Met QC Criteria

March 16, 2016

First Posted (Estimate)

March 22, 2016

Study Record Updates

Last Update Posted (Actual)

September 4, 2019

Last Update Submitted That Met QC Criteria

September 2, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Studio 96-15 CE 93321

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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