Function Integrity of Neck Anatomy in Thyroid Surgery

NCT04666103 | Recruiting DMC

• 1 other identifier: lycf202007
• Study Type: interventional
• Target: 1,264
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Thyroid lobectomy with intraoperative thermal ablation

EXPERIMENTAL

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

Thyroid lobectomy

NO INTERVENTION

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.

Interventions

Intraoperative thermal ablation PROCEDURE

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.

Thyroid lobectomy with intraoperative thermal ablation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Previous history of neck surgery
• Previous history of neck radiation therapy

Sponsors & Collaborators

• Wuhan University: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms; Thyroid Nodule

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Gaosong Wu, Ph.D.

  Department of Breast and Thyroid Surgery, Zhongnan Hospital of Wuhan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qianqian Yuan, M.D.

CONTACT

13026322297; Yuanqq11@whu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 14, 2020
• Study Start: December 11, 2020
• Primary Completion: December 31, 2021
• Study Completion (Estimated): December 12, 2026
• Last Updated: December 14, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)