Endoscopic Thyroidectomy Versus Open Thyroidectomy for Papillary Thyroid Carcinoma

Not Applicable

Not yet recruiting

• Conditions: Thyroid Cancer
• Interventions: Procedure: Endoscopic surgery;

• Registration Number: NCT05446441
• Lead Sponsor: Zhejiang Provincial People's Hospital

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.

Study Timeline

• Status Verified: 2022-06
• Study Start: 2022-06-28
• Study First Submitted: 2022-06-30
• Study First Submitted QC: 2022-06-30
• Last Update Submitted: 2022-06-30
• Study First Posted: 2022-07-06
• Last Update Posted: 2022-07-06
• Primary Completion: 2023-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 634

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Endoscopic surgery;	Conventional open surgery was performed in a standardized fashion by multi-institutional Chinese experienced surgeons.
Intervention;	Endoscopic surgery;	Endoscopic thyroidectomy was performed in a standardized fashion by multi-institutional Chinese experienced surgeons using the same gasless unilateral transaxillary approach.

Primary Outcome Measures

Name	Time	Method
Number of retrieved central lymph nodes	1 month after operation	The number of central lymph nodes removed during the operation