An observational study in Benign Thyroid Nodules, sponsored by Ming-an Yu. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-09-23.
Sponsored by Ming-an Yu · Observational
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.
207 studies on the registry are indexed under Thyroid Nodule; 64 are open to participants now.
This study's planned enrollment of 300 is above the median of 161 across 82 observational studies indexed under Thyroid Nodule.
Browse Thyroid Nodule studies →Ming-an Yu is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients treated with surgery, or staged thermal ablation in China-Japan Friendship Hospital
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients treated with thyroidectomy for benign thyroid nodules
Procedure: surgery
patients treated with staged thermal ablation for benign thyroid nodules
Procedure: staged thermal ablation
patients undergo conventional/open thyroidectomy or endoscopic thyroidectomy for large benign thyroid nodules
patients undergo multiple sessions of thermal ablation for large benign thyroid nodules
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 months
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 months
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 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.
Time frame: From enrollment to the end of treatment at 12 months
Plan to share: No — There is not a plan to make IPD available because of the patients privacy.
No publications or documents are linked to this record.
Start is estimated for Sep 2024; primary completion for Sep 2027, 36 months later.
Of 38 observational studies under Thyroid Nodule, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 32. This study's planned 36 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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