Ireland
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Recruiting Not applicable

Function Integrity of Neck Anatomy in Thyroid Surgery

NCT04666103 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2020-12-11
Last updated
2020-12-14

Condition(s) studied

Thyroid CarcinomaThyroid Nodule (Benign)Ablation; Retina

Investigational drug(s) / intervention(s)

Intraoperative thermal ablation

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Rate of complications — Up to 2 years
    Transient or persistent hypoparathyroidism confirmed by serum calcium levels was less than the lower limit at examination center and had symptoms of hypocalcemia. Postoperative vocal cord paralysis was defined as fixed vocal cord mobility with laryngofiberoscopic examination.
  • Scores of hospital anxiety and depression scale (HADS) — Up to 6 months
    All patients were requested to answer the HADS questionnaire, the scores of which were recorded.
  • Scores of fear of progression questionnaire-short form(FPQS) — Up to 6 months
    All patients were requested to answer the FPQS questionnaire, the scores of which were recorded.
  • Scores of thyroid cancer- specific quality of life (THYCA-QoL) questionnaire — Up to 6 months
    All patients were requested to answer the THYCA-QoL questionnaire, the scores of which were recorded.
  • Rate of recurrence — 5-year estimate reported after a median follow-up of 60 months
    Lymph node recurrence or distant recurrence

Trial sites (1)

FacilityCityRegionStatus
Zhongnan Hospital of Wuhan University Wuhan Hubei Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04666103 on ClinicalTrials.gov ↗ ← All trials in China