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Function Integrity of Neck Anatomy in Thyroid Surgery

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04666103
Enrollment
1264
Registered
2020-12-14
Start date
2020-12-11
Completion date
2026-12-12
Last updated
2020-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ablation; Retina, Thyroid Carcinoma, Thyroid Nodule (Benign)

Brief 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.

Interventions

PROCEDUREIntraoperative 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.

Sponsors

Wuhan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 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

Design outcomes

Primary

MeasureTime frameDescription
Rate of complicationsUp to 2 yearsTransient 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 monthsAll 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 monthsAll patients were requested to answer the FPQS questionnaire, the scores of which were recorded.
Scores of thyroid cancer- specific quality of life (THYCA-QoL) questionnaireUp to 6 monthsAll patients were requested to answer the THYCA-QoL questionnaire, the scores of which were recorded.
Rate of recurrence5-year estimate reported after a median follow-up of 60 monthsLymph node recurrence or distant recurrence

Countries

China

Contacts

Primary ContactQianqian Yuan, M.D.
Yuanqq11@whu.edu.cn13026322297

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026