Thermal Ablation Vs Thyroidectomy for Large Benign Thyroid Nodules
ConditionBenign Thyroid Nodules
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorMing-an Yu
About this trial
To compare the safety, efficacy and quality of life between staged thermal ablation and thyroidectomy in the treatment of Large benign thyroid nodules.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
benign thyroid nodules confirmed by surgical pathology in surgery group, and by two separate US-guided fine-needle aspiration (FNA) or core needle biopsy (CNB) in thermal ablation group;
the largest diameter of the nodule ≥4 cm;
the presence of nodule-related symptoms, cosmetic concerns, or psychological stress;
patients treated with surgery, or staged thermal ablation (who explicitly refused surgery);
Disqualifiers
suspicion of malignant nodule on ultrasound findings (e.g., marked hypoechoic, microcalcifications, or ill-defined margins);
comorbidities of other severe diseases;
without complete treatment and/or follow-up information
Trial population
patients treated with surgery, or staged thermal ablation in China-Japan Friendship Hospital
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
surgery
Procedure/Surgerypatients undergo conventional/open thyroidectomy or endoscopic thyroidectomy for large benign thyroid nodules
staged thermal ablation
Procedure/Surgerypatients undergo multiple sessions of thermal ablation for large benign thyroid nodules
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: surgery group1 intervention
Group B: thermal ablation group1 intervention
Trial outcomes
Primary outcomes
1
volume reduction ratio
The volume reduction ratio(VRR) = \[(preoperative volume - volume at the follow-up point)/preoperative volume\] × 100%. The volumes of the nodules were calculated using the following equation: V=π/6 a×b×c (where V is the volume, a is the maximum diameter, b and c are the other two perpendicular diameters).
Time frame
From enrollment to the end of treatment at 12 months2
Complications
Complications related to thermal ablation or thyroidectomy during treatment procedures, at the hospital stay and follow-ups.
Time frame
From enrollment to the end of treatment at 12 monthsSecondary outcomes
1
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire
Questionnaires of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) was used to evaluate the quality of life for cancer patients. All scales and single-item measures range from score 0-100 after linear transformation. The summary score of QLQ-C30 is used to measure the overall health-related quality-of-life (HRQoL), with a lower score indicating poorer HRQoL. And a higher score on the functional scales and global status scale indicates a better level of functioning and HRQoL, while a higher score on the symptom scales and single item means more discomfort and complaints.
Time frame
From enrollment to the end of treatment at 12 months2
Thyroid Cancer-Specific Quality of Life questionnaire
The Thyroid Cancer-Specific Quality of Life questionnaire (THYCA-QoL) was used to assess thyroid-specific symptoms in thyroid cancer survivors. The questionnaire consists of seven symptom scales (including neuromuscular, voice, concentration, sympathetic, throat/mouth, psychological and sensory problems) and six single items (including problems with scar, feeling chilly, tingling hands/feet, gained weight, headache, less interest in sex). A higher score on this scale implies more symptoms and complaints.
Time frame
From enrollment to the end of treatment at 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ming-an Yu
Lead sponsor
China-Japan Friendship Hospital
Sponsor institution
Source ClinicalTrials.gov
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