Endoscopic Thyroidectomy Versus Open Thyroidectomy for Papillary Thyroid Carcinoma

Zhejiang Provincial People's Hospital

Status: Not yet enrolling

Conditions: Thyroid Cancer

Treatments: Procedure: Endoscopic surgery;

Study type: Interventional

Funder types: Other

Identifiers

NCT05446441

2022（050）

Details and patient eligibility

About

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.

Full 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.

Enrollment: 634 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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634 participants in 2 patient groups

Intervention;

Experimental group

Description:

Endoscopic thyroidectomy was performed in a standardized fashion by multi-institutional Chinese experienced surgeons using the same gasless unilateral transaxillary approach.

Treatment:

Procedure: Endoscopic surgery;

Control

Active Comparator group

Description:

Conventional open surgery was performed in a standardized fashion by multi-institutional Chinese experienced surgeons.

Treatment:

Procedure: Endoscopic surgery;