Function Integrity of Neck Anatomy in Thyroid Surgery

Sponsor
Wuhan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04666103
Collaborator
(none)
1,264
1
2
72
17.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Intraoperative thermal ablation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1264 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Preserving Function Integrity of Neck Anatomy in Thyroid Surgery: A Randomized Clinical Trial
Actual Study Start Date :
Dec 11, 2020
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 12, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Rate of complications [Up to 2 years]

    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.

  2. Scores of hospital anxiety and depression scale (HADS) [Up to 6 months]

    All patients were requested to answer the HADS questionnaire, the scores of which were recorded.

  3. Scores of fear of progression questionnaire-short form(FPQS) [Up to 6 months]

    All patients were requested to answer the FPQS questionnaire, the scores of which were recorded.

  4. Scores of thyroid cancer- specific quality of life (THYCA-QoL) questionnaire [Up to 6 months]

    All patients were requested to answer the THYCA-QoL questionnaire, the scores of which were recorded.

  5. Rate of recurrence [5-year estimate reported after a median follow-up of 60 months]

    Lymph node recurrence or distant recurrence

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhongnan Hospital of Wuhan University Wuhan Hubei China 430071

Sponsors and Collaborators

  • Wuhan University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gaosong Wu, Ph D, MD, Director, Wuhan University
ClinicalTrials.gov Identifier:
NCT04666103
Other Study ID Numbers:
  • lycf202007
First Posted:
Dec 14, 2020
Last Update Posted:
Dec 14, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 14, 2020