Endoscopic Thyroidectomy Versus Open Thyroidectomy for Papillary Thyroid Carcinoma

Study Overview
=================
Brief Summary
-----------------
Recently, endoscopic thyroidectomy using gasless unilateral transaxillary approach has been proven feasible and safe in several Chinese medical centers. This study is aimed to compare multi-institutional Chinese outcomes of endoscopic thyroidectomy using gasless unilateral transaxillary approach and conventional open surgery.

Detailed Description
-----------------
Most patients with thyroid tumors are effectively treated surgically by practitioners experienced in the techniques of thyroidectomy. Many patients, especially women, undergoing thyroid surgery are concerned about the postoperative cosmetic appearance of the neck. Endoscopic thyroidectomy using gasless unilateral transaxillary approach which can hide the operative scar was associated with a higher degree of patient cosmetic satisfaction. Recently, endoscopic thyroidectomy using gasless unilateral transaxillary approach has been proven feasible and safe in several Chinese medical centers. In this study, we designed a prospective study comparing multi-institutional Chinese outcomes of endoscopic thyroidectomy using gasless unilateral transaxillary approach and conventional open surgery.

Official Title
-----------------
Endoscopic Thyroidectomy Using Gasless Unilateral Transaxillary Approach Versus Conventional Open Thyroidectomy for Papillary Thyroid Cancer: a Prospective, Multicenter, Randomized Controlled Clinical Trial

Conditions
-----------------
Thyroid Cancer

Intervention / Treatment
-----------------
* Procedure: Endoscopic surgery;


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years; The pathological type is papillary thyroid carcinoma; Tumor diameter <2 cm； No extraglandular invasion, or minimal extrathyroidal extension invading only anterior thyroid capsule or sternothyoid muscle； cN0 or cN+ without fusion and fixation of metastatic lymph nodes； no obvious contraindication for thyroidectomy ; Good comply with the research visit plan and other program requirements; Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: patients with severe systemic diseases who can not tolerate general anesthesia or routine surgical posture; previous history of neck surgery, radiotherapy or thermal ablation; hyperthyroidism and substernal goiter; dedifferentiated thyroid carcinoma； accompanied with severe thyroiditis.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention;<br>Endoscopic thyroidectomy was performed in a standardized fashion by multi-institutional Chinese experienced surgeons using the same gasless unilateral transaxillary approach. | Procedure: Endoscopic surgery;<br>* Endoscopic thyroidectomy group is the papillary thyroid carcinoma patient group who underwent endoscopic thyroid surgery using a gasless, trans-axillary approach.<br>|
| Active Comparator: Control<br>Conventional open surgery was performed in a standardized fashion by multi-institutional Chinese experienced surgeons. | Procedure: Endoscopic surgery;<br>* Endoscopic thyroidectomy group is the papillary thyroid carcinoma patient group who underwent endoscopic thyroid surgery using a gasless, trans-axillary approach.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of retrieved central lymph nodes | The number of central lymph nodes removed during the operation | 1 month after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thyroid Cancer, Endoscopic surgery, Open surgery, Radical thyroidectomy