Function Integrity of Neck Anatomy in Thyroid Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intraoperative thermal ablation.
- Who it may be relevant to
- Registry conditions: Thyroid Carcinoma, Thyroid Nodule (Benign), Ablation; Retina. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Preserving Function Integrity of Neck Anatomy in Thyroid Surgery: A Randomized Clinical Trial
Overview
Recent trends in the management of patients with low-risk papillary thyroid carcinoma who have a nonsuspicious or cytologically benign contralateral nodule call into question the need for routine total thyroidectomy. Although the lobectomy for the unilateral thyroid cancer with contralateral benign nodules is sufficient treatment, some of the patients might suffer from the anxiety of the residual benign thyroid nodule and tend to choose total thyroidectomy, which might be overtreatment. Thermal ablation has been proven to be effective in achieving nodule shrinkage and being also free from major complications. In our institution, intraoperative RFA was a proposed alternative strategy to treat the contralateral benign nodules after the thyroid lobectomy for the malignant lobe, which was found to have a better quality of life on anxiety, physiological health, social family, psychological and sensory mentions with a considerable complication rate.
Interventions
- Procedure Intraoperative thermal ablation
After the thyroid lobectomy, the contralateral benign thyroid nodule was treated with intraoperative thermal ablation. The "hydrodissection technique'' was used during the ablation process to prevent recurrent laryngeal nerve, esophageal and other important structures from being destroyed by heat energy.
Primary outcome measures
- Rate of complications [Time frame: Up to 2 years]
- Scores of hospital anxiety and depression scale (HADS) [Time frame: Up to 6 months]
- Scores of fear of progression questionnaire-short form(FPQS) [Time frame: Up to 6 months]
- Scores of thyroid cancer- specific quality of life (THYCA-QoL) questionnaire [Time frame: Up to 6 months]
- Rate of recurrence [Time frame: 5-year estimate reported after a median follow-up of 60 months]
Eligibility criteria
Inclusion criteria
- Patients diagnosed with unilateral thyroid carcinoma and contralateral benign nodule confirmed by preoperative ultrasound-guided fine-needle aspiration cytology;
- Patients with contralateral nodules ≤ 20mm and located in the thyroid gland;
- Patients with clinical node-negative cervical compartment at palpation and neck ultrasound.
Exclusion criteria
- Previous history of neck surgery
- Previous history of neck radiation therapy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zhongnan Hospital of Wuhan University — Wuhan
Identifiers
NCT: NCT04666103 · lycf202007