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Function Integrity of Neck Anatomy in Thyroid Surgery

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intraoperative thermal ablation
Sponsored by
Wuhan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhongnan Hospital of Wuhan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Thyroid lobectomy with intraoperative thermal ablation

Thyroid lobectomy

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
Scores of hospital anxiety and depression scale (HADS)
All patients were requested to answer the HADS questionnaire, the scores of which were recorded.
Scores of fear of progression questionnaire-short form(FPQS)
All patients were requested to answer the FPQS questionnaire, the scores of which were recorded.
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.
Rate of recurrence
Lymph node recurrence or distant recurrence

Secondary Outcome Measures

Full Information

First Posted
December 7, 2020
Last Updated
December 11, 2020
Sponsor
Wuhan University
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1. Study Identification

Unique Protocol Identification Number
NCT04666103
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Recruiting
Study Start Date
December 11, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 12, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wuhan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Carcinoma, Thyroid Nodule (Benign), Ablation; Retina

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thyroid lobectomy with intraoperative thermal ablation
Arm Type
Experimental
Arm 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.
Arm Title
Thyroid lobectomy
Arm Type
No Intervention
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Intraoperative thermal ablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of complications
Description
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 years
Title
Scores of hospital anxiety and depression scale (HADS)
Description
All patients were requested to answer the HADS questionnaire, the scores of which were recorded.
Time Frame
Up to 6 months
Title
Scores of fear of progression questionnaire-short form(FPQS)
Description
All patients were requested to answer the FPQS questionnaire, the scores of which were recorded.
Time Frame
Up to 6 months
Title
Scores of thyroid cancer- specific quality of life (THYCA-QoL) questionnaire
Description
All patients were requested to answer the THYCA-QoL questionnaire, the scores of which were recorded.
Time Frame
Up to 6 months
Title
Rate of recurrence
Description
Lymph node recurrence or distant recurrence
Time Frame
5-year estimate reported after a median follow-up of 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qianqian Yuan, M.D.
Phone
13026322297
Email
Yuanqq11@whu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaosong Wu, Ph.D.
Organizational Affiliation
Department of Breast and Thyroid Surgery, Zhongnan Hospital of Wuhan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qianqian Yuan, MD.
Phone
+8613026322297
Email
Yuanqq11@whu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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Function Integrity of Neck Anatomy in Thyroid Surgery

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