Percutaneous Thermo-ablation for the Treatment of Benign Thyroid Nodules
ConditionBenign Thyroid Nodule
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Ghent
About this trial
The goal of this observational study is to learn if radiofrequency ablation (RFA), a minimally invasive thermoablation technique, can safely reduce symptoms and improve quality of life in adults with symptomatic benign thyroid nodules or autonomously functioning thyroid nodules.
The main questions it aims to answer are:
* Does RFA improve health-related quality of life (HRQoL) as measured by the ThyPRO-39 questionnaire? * Does RFA effectively reduce nodule volume and related symptoms (compressive or cosmetic)?
Participants will:
* Undergo a radiofrequency ablation procedure of the thyroid nodule performed under ultrasound guidance in an outpatient setting. * Complete quality of life questionnaires (ThyPRO-39) before treatment and at follow-up visits.
Attend follow-up visits at 1, 3, 6, and 12 months with:
* Ultrasound assessments of the thyroid nodule * Symptom and cosmetic scoring * Blood tests to monitor thyroid function * Safety checks for possible complications
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
> 18 years old
'Eastern Cooperative Oncology Group' (ECOG) performance status of 0 or 1
Symptomatic benign thyroid nodules with compressive/cosmetic complaints OR autonomously functioning thyroid nodules with subclinical hyperthyreosis or thyrotoxicosis proven on scintigraphy.
No cutoff in nodule size.
Disqualifiers
<18y
Purely cystic nodule
Severe comorbidity which limits the further life expectancy of the patient to < 2 years (opinion of the physician)
Malignancies <2 years ago except for non-melanoma skin cancer and non-muscle invasive bladder cancer.
Trial population
Study participants will be selected from the following Belgian hospitals: Ghent University Hospital, University Hospital Leuven, AZ Sint Jan Brugge.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Percutaneous radiofrequency ablation
DeviceRFA uses an electric field, produced by a radiofrequency generator connected to an internally cooled electrode needle, leading to frictional agitation at the ionic level and to heat generation (Joule effect). The electrode is introduced under US guidance into the target nodule, and a continuous repositioning of the applicator ("moving shot" or "multiple overlapping shot" technique). The localized heating causes necrosis and shrinkage of the thyroid nodule without damaging surrounding tissues. The appearance of hyperechoic signals close to the electrode tip indicates the development of tissue changes and air formation, while a steep rise in tissue impedance demonstrates the achievement of tissue necrosis
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Benign thyriod nodules1 intervention
Trial outcomes
Primary outcomes
1
Health related Quality Of Life (HRQoL)
HRQoL will be assessed by the change in Thyroid-Related Patient-Reported Outcome 39 (ThyPRO-39) score from baseline to 1-year follow-up. The ThyPRO-39 is a thyroid-specific quality of life instrument covering 13 domains of QoL validated for patients with benign thyroid disease. The ThyPRO-39 includes scales assessing the following: goiter symptoms, eye symptoms, hyperthyroid symptoms, hypothyroid symptoms, tiredness, cognitive complaints, anxiety, depressivity, emotional susceptibility, impaired social life, impaired daily life, appearance, and overall QoL. Each item is rated on a Likert scale (0-4) from 0 = "no symptoms/problems" to 4 = "severe symptoms/problems." Scores are then transformed to yield 13 0-100 scales, where a higher score indicates worse health-related QoL
Time frame
From baseline (before treatment) to 12 months after the radiofrequency ablation procedure, with assessments at baseline, 1 month, 3 months, 6 months, and 12 monthsSecondary outcomes
1
Symptom score
Registered on a Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates "no symptoms" and 10 indicates "worst imaginable symptoms".
Time frame
From baseline (before treatment) to 12 months after the radiofrequency ablation procedure, with assessments at baseline, 1 month, 3 months, 6 months, and 12 months.2
Cosmetic score
Assessed during physical examination; ranging from 1 to 4, where 1 graded as no palpable mass, 2 graded as a palpable mass without cosmetic issue, 3 graded as a cosmetic problem on swallowing, and 4 as a readily detected cosmetic problem.
Time frame
From baseline (before treatment) to 12 months after the radiofrequency ablation procedure, with assessments at baseline, 1 month, 3 months, 6 months, and 12 months.3
Number of Participants with Treatment-Related Adverse Events
Safety will be measured based on the presence of minor or major complications. Major and minor complications are those defined by the Society of Interventional Radiology.
Time frame
From baseline (before treatment) to 12 months after the radiofrequency ablation procedure, with assessments at baseline, 1 month, 3 months, 6 months, and 12 months.4
Volume Reduction Rate (VRR)
Calculated as VRR (%) = (initial volume - final volume) ÷ initial volume × 100
Time frame
From baseline (before treatment) to 12 months after the radiofrequency ablation procedure, with assessments at baseline, 1 month, 3 months, 6 months, and 12 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Ghent
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborator
AZ Sint-Jan AV
Collaborator
Source ClinicalTrials.gov