NCT05545852

A Clinical Study of Transaxillary Endoscopic and Open Thyroidectomy for PTC

A Multicenter, Randomized, Controlled Clinical Study on the Feasibility and Safety of Gasless Transaxillary Posterior Endoscopic and Open Thyroidectomy for Papillary Thyroid Cancer.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 290 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the feasibility and safety of gasless transaxillary posterior endoscopic thyroidectomy (Resection of thyroid lobe and isthmus, lymph node dissection in the central area of the affected side) and open radical thyroidectomy (Resection of thyroid lobe and isthmus, lymph node dissection in the central area of the affected side) as the current standard surgical treatment mode in terms of feasibility and safety of radical thyroidectomy.

Detailed description

Subjects that suffering from papillary thyroid carcinoma will be randomized into Study Group (gasless transaxillary posterior endoscopic thyroidectomy ) or Control Group (conventional open thyroidectomy). Measure the outcomes as following, early complication rate, life quality score, the number of dissected lymph nodes, the volume of residual gland, 3-year recurrence rate, operation duration, hospital stays, hospitalization expense, and inflammatory and immune response.

Conditions

• Papillary Thyroid Cancer

Interventions

Type	Name	Description
PROCEDURE	GTPET(Gasless Transaxillary Posterial Endoscopic Thyroidectomy)	Gasless Transaxillary Posterial Endoscopic Thyroidectomy and Ipsilateral Central Lymph Node Dissection
PROCEDURE	COT(Conventional Open Thyroidectomy)	Conventional Open Thyroidectomy and Ipsilateral Central Lymph Node Dissection

Timeline

• Start date: 2021-06-01
• Primary completion: 2024-05-31
• Completion: 2025-05-31
• First posted: 2022-09-19
• Last updated: 2023-10-18

Locations

1 site across 1 country: China