Function Integrity of Neck Anatomy in Thyroid Surgery

NCT ID: NCT04666103

Last Updated: 2020-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-11

Study Completion Date

2026-12-12

Brief Summary

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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.

Detailed Description

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Conditions

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Thyroid Carcinoma Thyroid Nodule (Benign) Ablation; Retina

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Intraoperative thermal ablation

Intervention Type 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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wuhan University

OTHER

Sponsor Role lead

Responsible Party

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Gaosong Wu, Ph D, MD

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gaosong Wu, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qianqian Yuan, M.D.

Role: CONTACT

Phone: 13026322297

Email: [email protected]

Facility Contacts

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Qianqian Yuan, MD.

Role: primary

Other Identifiers

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lycf202007

Identifier Type: -

Identifier Source: org_study_id