Function Integrity of Neck Anatomy in Thyroid Surgery

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Brief Title

Function Integrity of Neck Anatomy in Thyroid Surgery

Official Title

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

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.
    



Study Type

Interventional


Primary Outcome

Rate of complications


Condition

Thyroid Carcinoma

Intervention

Intraoperative thermal ablation

Study Arms / Comparison Groups

 Thyroid lobectomy with intraoperative thermal ablation
Description:  Thyroid lobectomy was performed with a standard technique of fine capsular en bloc dissection and resection, from inferior pole to superior pole. Superior parathyroid glands were identified and preserved in situ, inferior parathyroid glands were protected in situ or autotransplanted in the sternocleidomastoid muscle according to three certain types based on their blood supply and location. All the patients underwent lobectomy received ipsilateral therapic central compartment neck dissection. 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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

1264

Start Date

December 11, 2020

Completion Date

December 12, 2026

Primary Completion Date

December 31, 2021

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
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Gaosong Wu, Ph.D., 13026322297, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04666103

Organization ID

lycf202007


Responsible Party

Principal Investigator

Study Sponsor

Wuhan University


Study Sponsor

Gaosong Wu, Ph.D., Principal Investigator, Department of Breast and Thyroid Surgery, Zhongnan Hospital of Wuhan University


Verification Date

December 2020