Benign Thyroid Nodules
Conditions
Keywords
thermal ablation, Thyroidectomy
Brief summary
To compare the safety, efficacy and quality of life between staged thermal ablation and thyroidectomy in the treatment of Large benign thyroid nodules.
Detailed description
Large benign thyroid nodules （BTNs）usually cause compressive symptoms or cosmetic concerns and therefore require treatment. Thyroidectomy remains the mainstay treatment for large, symptomatic BTNs. However, if surgery is not feasible or refused, ablative approach could be considered in selected patients. However, it has been proved that single application of thermal ablation is less effective in causing shrinkage in large thyroid nodules. The possible reason is that it is difficult for single application of thermal ablation to cover all of the nodule tissue in a three-dimension if the nodule is large. In addition, nodule locations adjacent to vital structures might hinder complete treatment in one session because of safety concerns. Few studies reveal that staged thermal ablation (Pre-designed multiple sessions of thermal ablation) can also achieve complete ablation and adequate volume reduction of large benign thyroid nodules. However, there is a lack of comparison between these two methods. Thus, this study is aimed to compare the safety, efficacy, quality of life between staged thermal ablation and thyroidectomy for treating large benign thyroid nodules.
Interventions
PROCEDUREsurgery
patients undergo conventional/open thyroidectomy or endoscopic thyroidectomy for large benign thyroid nodules
PROCEDUREstaged thermal ablation
patients undergo multiple sessions of thermal ablation for large benign thyroid nodules
Sponsors
Ming-an Yu
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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); * more than 12-month follow-up duration
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complications | From enrollment to the end of treatment at 12 months | Complications related to thermal ablation or thyroidectomy during treatment procedures, at the hospital stay and follow-ups. |
| volume reduction ratio | From enrollment to the end of treatment at 12 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| European Organization for Research and Treatment of Cancer Quality of Life Questionnaire | From enrollment to the end of treatment at 12 months | 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. |
| Thyroid Cancer-Specific Quality of Life questionnaire | From enrollment to the end of treatment at 12 months | 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. |
Countries
China
Contacts
Primary ContactMing-an Yu, MD
Outcome results
None listed