Function Integrity of Neck Anatomy in Thyroid Surgery

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

Study Overview

• Status: Recruiting
• Conditions: Thyroid Carcinoma; Thyroid Nodule (Benign); Ablation; Retina
• Intervention / Treatment: Procedure: Intraoperative thermal ablation

• Study Type: Interventional
• Enrollment (Anticipated): 1264
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qianqian Yuan, M.D.; Phone Number: 13026322297; Email: Yuanqq11@whu.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430071
      • Recruiting
      • Zhongnan Hospital Of Wuhan University
      • Contact: Qianqian Yuan, MD.; Phone Number: +8613026322297; Email: Yuanqq11@whu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thyroid lobectomy with intraoperative thermal ablation; 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.	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.
No Intervention: Thyroid lobectomy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Rate of recurrence	Lymph node recurrence or distant recurrence	5-year estimate reported after a median follow-up of 60 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 12, 2026

Study Registration Dates

• First Submitted: December 7, 2020
• First Submitted That Met QC Criteria: December 11, 2020
• First Posted (Actual): December 14, 2020

Study Record Updates

• Last Update Posted (Actual): December 14, 2020
• Last Update Submitted That Met QC Criteria: December 11, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms; Thyroid Nodule
• Other Study ID Numbers: lycf202007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No