Function Integrity of Neck Anatomy in Thyroid Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWuhan University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Previous history of neck surgery
Previous history of neck radiation therapy
Trial design
Design model
Parallel
Treatments tested in this trial
Intraoperative thermal ablation
Procedure/SurgeryAfter 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.
Treatment groups
1,264 Participants
are divided into 2 treatment groupsGroup A: Thyroid lobectomy with intraoperative thermal ablationExperimental treatment 1 intervention
Group B: Thyroid lobectomyNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 2 years2
Scores of hospital anxiety and depression scale (HADS)
All patients were requested to answer the HADS questionnaire, the scores of which were recorded.
Time frame
Up to 6 months3
Scores of fear of progression questionnaire-short form(FPQS)
All patients were requested to answer the FPQS questionnaire, the scores of which were recorded.
Time frame
Up to 6 months4
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.
Time frame
Up to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov