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Laser Ablation Versus Radiofrequency Ablation for Thyroid Nodules (LARA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02714946
Recruitment Status : Active, not recruiting
First Posted : March 22, 2016
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Silvia Manfrini, Campus Bio-Medico University

Tracking Information
First Submitted Date  ICMJE February 19, 2016
First Posted Date  ICMJE March 22, 2016
Last Update Posted Date September 4, 2019
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2016)
  • 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
  • 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
  • Variation in TSH levels after treatment [ Time Frame: 12 months ]
    Variation in TSH value (mUI/ml) before and after LA and RFA
  • 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
  • Complications [ Time Frame: Up to 1 year follow-up ]
    Differences in the rate of complications and side effects between LA and RFA
  • Tolerability evaluated by McGill Pain Questionnaire [ Time Frame: 0 and 6 months ]
    Tolerability will be evaluated by McGill Pain Questionnaire, Melzack 1975, italian version
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Laser Ablation Versus Radiofrequency Ablation for Thyroid Nodules
Official Title  ICMJE Prospective Randomized Comparative Study of the Effectiveness and Safety of Ultrasound-guided Laser and Radiofrequency Ablation for the Treatment of Benign Thyroid Nodules
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Thyroid Nodule
Intervention  ICMJE
  • 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.
  • 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
Study Arms  ICMJE
  • Active Comparator: LA Arm
    Percutaneous Laser Ablation
    Intervention: Device: Percutaneous Laser Ablation
  • Active Comparator: RFA Arm
    Percutaneous Radiofrequency Ablation
    Intervention: Device: Percutaneous Radiofrequency Ablation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 16, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02714946
Other Study ID Numbers  ICMJE Studio 96-15 CE 93321
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. Silvia Manfrini, Campus Bio-Medico University
Study Sponsor  ICMJE Campus Bio-Medico University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Roberto Cianni Santa Maria Goretti Hospital
PRS Account Campus Bio-Medico University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP