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Safety of Endoscopic Thyroidectomy Via Retro-Auricular Single-Site Approach, Transoral Approach and Transareola

Sun Yat-sen University logo

Sun Yat-sen University

Status

Completed

Conditions

Papillary Thyroid Carcinoma

Treatments

Procedure: Retro-Auricular Single-Site Endoscopic Thyroidectomy
Procedure: Transareola Endoscopic Thyroidectomy
Procedure: Transoral Endoscopic Thyroidectomy Vestibular Approach

Study type

Interventional

Funder types

Other

Identifiers

NCT05760690
B2022-359-01

Details and patient eligibility

About

The goal of this retrospective study is to compare the safety and efficiacy of endoscopic thyroidectomy via retro-auricular single-site approach, transoral endoscopic thyroidectomy vestibular approach and transareola approach.

Enrollment

160 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Age 18-70 years old, no gender restrictions.
  2. Fine-needle aspiration cytology(FNA) confirmed papillary thyroid carcinoma(PTC).
  3. Early stage PTC (stage T1N0M0).
  4. Preoperative ultrasonography showed unilateral glandular lobe malignant tumor and the largest diameter was not more than 2cm, without cervical lymph node metastasis and extensive metastasis.
  5. Patients undergoing thyroid lobectomy and central lymph node dissection.
  6. Patients who have signed an approved Informed Consent.

Exclusion criteria

  1. Patients who do not accept case data collection for various reasons.
  2. The clinical data unfit this study (at the discretion of the investigator).
  3. Patients who have undergone neck surgery or radiotherapy before this trail.
  4. Patients who have uncontrolled hyperthyroidism.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

160 participants in 3 patient groups

Retro-Auricular Single-Site Endoscopic Thyroidectomy group
Experimental group
Description:
Patients in the retro-auricular single-site endoscopic thyroidectomy (RASSET) group will receive endoscopic thyroid lobectomy and central lymph node dissection.
Treatment:
Procedure: Retro-Auricular Single-Site Endoscopic Thyroidectomy
Transoral Endoscopic Thyroidectomy Vestibular Approach group
Active Comparator group
Description:
Patients in the Transoral Endoscopic Thyroidectomy Vestibular Approach group will receive endoscopic thyroid lobectomy and central lymph node dissection.
Treatment:
Procedure: Transoral Endoscopic Thyroidectomy Vestibular Approach
Transareola Endoscopic Thyroidectomy group
Active Comparator group
Description:
Patients in the Transareola Endoscopic Thyroidectomy group will receive endoscopic thyroid lobectomy and central lymph node dissection.
Treatment:
Procedure: Transareola Endoscopic Thyroidectomy

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Dian Ouyang

Data sourced from clinicaltrials.gov

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