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Study of the Feasibility of Radiofrequency Ablation of Benign Thyroid Nodules (TRAF)

Primary Purpose

Benign Thyroid Nodules

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Radiofrequency ablation
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Thyroid Nodules focused on measuring benign thyroid nodule, radiofrequency, symptomatic thyroid nodule

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Euthyroid or hypothyroidism properly substituted with normal TSH
  • Benin nodule proved by FNA (Bethesda) and normal Calcitonin
  • Nodule size> 1cm and / or increase in size
  • Single nodule or asymptomatic nodules associated
  • Symptomatic nodule with functional impairment and / or aesthetic Patient Agreement
  • Patient with insurance coverage
  • Written agreement for participation

Exclusion Criteria:

The exclusion criteria are related to the histological nature of the nodule and the necessary of the procedure:

  • Allergy to local anesthetics
  • FNA non-contributory or suspicious nodule (Bethesda)
  • Multiple nodules more than 2cm
  • Hyperthyroidism or hyperparathyroidism associated requiring surgical intervention.
  • Taking a treatment with anticoagulant or double antiplatelet
  • Patient with a Pacemaker
  • Contralateral laryngeal paralysis in nodule
  • Purely cystic nodule
  • Nodule in contact with the recurrent nerve
  • Patient Refusal
  • Pregnant and breastfeeding women
  • Patient trust, guardianship or safeguard justice.

Sites / Locations

  • CHU Toulouse, Hôpital Larrey

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment with radiofrequency

Arm Description

Treatment of symptomatic benign nodules with radiofrequency ablation as an alternative to surgical treatment

Outcomes

Primary Outcome Measures

Procedure response rate
First estimate of the procedure response rate (patient with complete procedure in percentage)

Secondary Outcome Measures

Change in nodular volume
compared to the volume measured at inclusion. This reduction will be estimated in absolute value and in relative value (percentage reduction for a given subject)
volume change of nodules by at least 50 percent, at 6 months
Percentage of patients with a volume decrease of at least 50 percent, 6 months after the procedure. Patients for which the procedure could not be fully performed will be counted among patients who have not had a reduction of at least 50 percent
volume change of nodules by at least 50 percent, at 12 months
Percentage of patients with a volume decrease of at least 50 percent, 12 months after the procedure. Patients for which the procedure could not be fully performed will be counted among patients who have not had a reduction of at least 50 percent
complete disappearance of symptoms
The symptoms will be evaluated by a visual analogue scale of 0 to 10 as proposed by the Korean consensus. The symptoms assessed will be: cervical pain, dysphagia, foreign body sensation, discomfort, coughing.
aesthetic change
This improvement will be evaluated with a 4-level scale (no clinically detectable nodule 0, palpable nodule 1, visible nodule on swallowing 2, spontaneously visible nodule 3) as proposed by the Korean consensus. The improvement will be defined by the transition to the lower category.
one or more complications
In particular, the following will be investigated: signs of cutaneous involvement such as burns, hematoma and intra-nodular bleeding, recurrent paralysis, superinfections, tracheal or esophageal wounds.
Assessment of pain during the procedure with visual analogue scale
Evaluation of the pain during the procedure using a visual analogue scale from 0 to 10 established at the end of the procedure
patients requiring L-thyroxine replacement therapy
Percentage of patients requiring L-thyroxine replacement therapy
Economic evaluation from the point of view of the hospital
evaluation, from the point of view of the hospital, of the production cost of the new technique
patients who have used analgesics
Percentage of patients who have used analgesics during and after the procedure
Economic evaluation from the point of view of the health insurance
Evaluation, from the point of view of health insurance, of the cost of the care of patients who benefited from the new technique

Full Information

First Posted
March 25, 2018
Last Updated
March 29, 2023
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT03646383
Brief Title
Study of the Feasibility of Radiofrequency Ablation of Benign Thyroid Nodules
Acronym
TRAF
Official Title
Study of the Feasibility of Radiofrequency Ablation of Benign Thyroid Nodules by Percutaneous Radiological Approach
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 29, 2019 (Actual)
Primary Completion Date
December 27, 2022 (Actual)
Study Completion Date
December 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the present protocol is to evaluate the response rate to treatment of these symptomatic benign nodules with radiofrequency as an alternative to surgical treatment. This thyroid nodules ablation with radiofrequency will be directed by a single percutaneous procedure guided by ultrasound. The procedure includes an ultrasound with percutaneously radiofrequency ablation of benign thyroid nodule. Clinical and ultrasonographic monitoring will last a year with consultations at 2 weeks (consultation only), 3 months, 6 months and 1 year (consultation, ultrasound TSH). The success of this procedure will be controlled with 3 successive ultrasounds the following year. The expected results are a decrease in the size of the nodule by at least 50% and a reduction in the functional and aesthetic discomfort, with less frequent complication than what is expected with surgery. The present study also intends to determine the medico economic impact of this technique compared to surgery.
Detailed Description
Thyroid benign nodules represent a major public health problem because they are very common (subclinical nodules were found in half of woman beyond 60 years). The main risk factors include age, female gender, parity, smoking and family history of thyroid nodules or thyroiditis. The assessment is based on biology, ultrasound and fine needle aspiration and intends to determine the benign nature (95%) or cancer (5%) of the nodules and if they are functional or not (toxic nodule). Most benign nodules are asymptomatic but some of them because of their size and location can cause a functional disorder (compression or swallowing disorder) or aesthetic and psychological resounding.In current practice, these nodules are sometimes treated with surgery that impact on patient quality of life (need to take L-Thyroxine, difficulties related to the possible occurrence of complications like hypoparathyroidism or laryngeal paralysis) and socio-economic constraints especially when complications occur. To limit the number of unnecessary and potentially risky surgeries, patients should therefore be well selected. If surgery is the preferred treatment of thyroid cancer, alternative techniques like radiofrequency seem interesting for benign nodules.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Thyroid Nodules
Keywords
benign thyroid nodule, radiofrequency, symptomatic thyroid nodule

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment with radiofrequency
Arm Type
Experimental
Arm Description
Treatment of symptomatic benign nodules with radiofrequency ablation as an alternative to surgical treatment
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency ablation
Intervention Description
The procedure will include an ultrasound with radiofrequency ablation of the benign thyroid nodule percutaneously
Primary Outcome Measure Information:
Title
Procedure response rate
Description
First estimate of the procedure response rate (patient with complete procedure in percentage)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in nodular volume
Description
compared to the volume measured at inclusion. This reduction will be estimated in absolute value and in relative value (percentage reduction for a given subject)
Time Frame
at 6 and 12 months
Title
volume change of nodules by at least 50 percent, at 6 months
Description
Percentage of patients with a volume decrease of at least 50 percent, 6 months after the procedure. Patients for which the procedure could not be fully performed will be counted among patients who have not had a reduction of at least 50 percent
Time Frame
at 6 months
Title
volume change of nodules by at least 50 percent, at 12 months
Description
Percentage of patients with a volume decrease of at least 50 percent, 12 months after the procedure. Patients for which the procedure could not be fully performed will be counted among patients who have not had a reduction of at least 50 percent
Time Frame
at 12 months
Title
complete disappearance of symptoms
Description
The symptoms will be evaluated by a visual analogue scale of 0 to 10 as proposed by the Korean consensus. The symptoms assessed will be: cervical pain, dysphagia, foreign body sensation, discomfort, coughing.
Time Frame
at 12 months
Title
aesthetic change
Description
This improvement will be evaluated with a 4-level scale (no clinically detectable nodule 0, palpable nodule 1, visible nodule on swallowing 2, spontaneously visible nodule 3) as proposed by the Korean consensus. The improvement will be defined by the transition to the lower category.
Time Frame
at 3, 6 and 12 months
Title
one or more complications
Description
In particular, the following will be investigated: signs of cutaneous involvement such as burns, hematoma and intra-nodular bleeding, recurrent paralysis, superinfections, tracheal or esophageal wounds.
Time Frame
at 6 and 12 months
Title
Assessment of pain during the procedure with visual analogue scale
Description
Evaluation of the pain during the procedure using a visual analogue scale from 0 to 10 established at the end of the procedure
Time Frame
between Day 1 and Day 15
Title
patients requiring L-thyroxine replacement therapy
Description
Percentage of patients requiring L-thyroxine replacement therapy
Time Frame
at 6 and 12 months
Title
Economic evaluation from the point of view of the hospital
Description
evaluation, from the point of view of the hospital, of the production cost of the new technique
Time Frame
Between Day 1 and 12 months
Title
patients who have used analgesics
Description
Percentage of patients who have used analgesics during and after the procedure
Time Frame
between Day 1 and Day 15
Title
Economic evaluation from the point of view of the health insurance
Description
Evaluation, from the point of view of health insurance, of the cost of the care of patients who benefited from the new technique
Time Frame
Between Day 1 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Euthyroid or hypothyroidism properly substituted with normal TSH Benin nodule proved by FNA (Bethesda) and normal Calcitonin Nodule size> 1cm and / or increase in size Single nodule or asymptomatic nodules associated Symptomatic nodule with functional impairment and / or aesthetic Patient Agreement Patient with insurance coverage Written agreement for participation Exclusion Criteria: The exclusion criteria are related to the histological nature of the nodule and the necessary of the procedure: Allergy to local anesthetics FNA non-contributory or suspicious nodule (Bethesda) Multiple nodules more than 2cm Hyperthyroidism or hyperparathyroidism associated requiring surgical intervention. Taking a treatment with anticoagulant or double antiplatelet Patient with a Pacemaker Contralateral laryngeal paralysis in nodule Purely cystic nodule Nodule in contact with the recurrent nerve Patient Refusal Pregnant and breastfeeding women Patient trust, guardianship or safeguard justice.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire RENAUD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Toulouse, Hôpital Larrey
City
Toulouse
ZIP/Postal Code
31400
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26462967
Citation
Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020.
Results Reference
background
PubMed Identifier
24122763
Citation
Fuller CW, Nguyen SA, Lohia S, Gillespie MB. Radiofrequency ablation for treatment of benign thyroid nodules: systematic review. Laryngoscope. 2014 Jan;124(1):346-53. doi: 10.1002/lary.24406. Epub 2013 Oct 22.
Results Reference
background
PubMed Identifier
26061686
Citation
Deandrea M, Sung JY, Limone P, Mormile A, Garino F, Ragazzoni F, Kim KS, Lee D, Baek JH. Efficacy and Safety of Radiofrequency Ablation Versus Observation for Nonfunctioning Benign Thyroid Nodules: A Randomized Controlled International Collaborative Trial. Thyroid. 2015 Aug;25(8):890-6. doi: 10.1089/thy.2015.0133. Epub 2015 Jul 13.
Results Reference
background
PubMed Identifier
28463597
Citation
Hong MJ, Na DG, Baek JH, Sung JY, Kim JH. Cytology-Ultrasonography Risk-Stratification Scoring System Based on Fine-Needle Aspiration Cytology and the Korean-Thyroid Imaging Reporting and Data System. Thyroid. 2017 Jul;27(7):953-959. doi: 10.1089/thy.2016.0603. Epub 2017 May 19.
Results Reference
background
PubMed Identifier
27559968
Citation
Chen F, Tian G, Kong D, Zhong L, Jiang T. Radiofrequency ablation for treatment of benign thyroid nodules: A PRISMA-compliant systematic review and meta-analysis of outcomes. Medicine (Baltimore). 2016 Aug;95(34):e4659. doi: 10.1097/MD.0000000000004659.
Results Reference
background

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Study of the Feasibility of Radiofrequency Ablation of Benign Thyroid Nodules

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