Function Integrity of Neck Anatomy in Thyroid Surgery

Thyroid Carcinoma Clinical Trial

Official title:

Preserving Function Integrity of Neck Anatomy in Thyroid Surgery: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04666103
• Other study ID #: lycf202007
• Status: Recruiting
• Phase: N/A
• Start date: December 11, 2020
• Est. completion date: December 12, 2026

Study information

• Verified date: December 2020
• Source: Wuhan University
• Contact: Qianqian Yuan, M.D.
• Phone: 13026322297
• Email: Yuanqq11[@]whu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1264
• Est. completion date: December 12, 2026
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Ablation; Retina
• Thyroid Carcinoma
• Thyroid Diseases
• Thyroid Neoplasms
• Thyroid Nodule
• Thyroid Nodule (Benign)

Intervention

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.

Locations

Country	Name	City	State
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of complications	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.	Up to 2 years
Primary	Scores of hospital anxiety and depression scale (HADS)	All patients were requested to answer the HADS questionnaire, the scores of which were recorded.	Up to 6 months
Primary	Scores of fear of progression questionnaire-short form(FPQS)	All patients were requested to answer the FPQS questionnaire, the scores of which were recorded.	Up to 6 months
Primary	Scores of thyroid cancer- specific quality of life (THYCA-QoL) questionnaire	All patients were requested to answer the THYCA-QoL questionnaire, the scores of which were recorded.	Up to 6 months
Primary	Rate of recurrence	Lymph node recurrence or distant recurrence	5-year estimate reported after a median follow-up of 60 months