Clinical trial NCT05263141: Retro-Auricular Single-Site Endoscopic to Papillary Thyroid Carcinoma
Official title: Single-center, Prospective, Non-Randomized Control Clinical Trial of Retro-Auricular Single-Site Endoscopic Versus Open Surgery in Patients With Early Stage Papillary Thyroid Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Papillary Thyroid Carcinoma
Keywords: Papillary Thyroid Carcinoma
Thyroidectomy
Laparoscopy
Retroauricular approach
Single-site
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this non randomized control clinical research study is to compare the cosmetic outcomes and efficiacy of retro-auricular single-site endoscopic thyroid lobectomy and central lymph node dissection against conventional resection.


Eligibility criteria: 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.

Primary outcomes:
measure: postoperative cosmetic satisfaction scores
timeFrame: 3 months from surgery
Secondary outcomes:
measure: postoperative Vancouver Scar Scale
timeFrame: 3 months from surgery
measure: postoperative Vancouver Scar Scale
timeFrame: 1 month from surgery
measure: Intra-operative, peri-operative, post-operative clinicopathologic characteristics
timeFrame: 1 week from surgery
measure: postoperative cosmetic satisfaction scores
timeFrame: 1 month from surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Dian Ouyang
role: STUDY_CHAIR
References:
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