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To compare the safety, efficacy and quality of life between staged thermal ablation and thyroidectomy in the treatment of Large benign thyroid nodules.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| surgery group | patients treated with thyroidectomy for benign thyroid nodules |
| |
| thermal ablation group | patients treated with staged thermal ablation for benign thyroid nodules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| surgery | Procedure | patients undergo conventional/open thyroidectomy or endoscopic thyroidectomy for large benign thyroid nodules |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From enrollment to the end of treatment at 12 months |
| Complications | Complications related to thermal ablation or thyroidectomy during treatment procedures, at the hospital stay and follow-ups. | From enrollment to the end of treatment at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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patients treated with surgery, or staged thermal ablation in China-Japan Friendship Hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming-an Yu, MD | Contact | 86-84205756 | yma301@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | 100029 | China |
There is not a plan to make IPD available because of the patients privacy.
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| staged thermal ablation | Procedure | patients undergo multiple sessions of thermal ablation for large benign thyroid nodules |
|
| From enrollment to the end of treatment at 12 months |
| 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. | From enrollment to the end of treatment at 12 months |