Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06623578
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Comparative Study of Transaxillary Robotic Thyroidectomy With MRND Versus Conventional Open Surgery in N1b PTC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparative Study of Transaxillary Robotic Thyroidectomy With Modified Radical Neck Dissection Versus Conventional Open Surgery in Patients With Papillary Thyroid Carcinoma and Lateral Neck Node Metastases a Prospective Multicenter Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Thyroid cancer is one of the most common malignant tumors in women ranking seventh in the United States and fourth in China Papillary thyroid carcinoma is the most common pathological type about 85 to 90 of thyroid cancers and lateral cervical lymph node metastasis can reach 06-375 at diagnosis For papillary thyroid cancer with lateral cervical lymph node metastasis the 2015 ATA Guidelines in the United States recommend surgical resection and neck lymph node dissection as the primary treatment Traditional cervical lymph node dissection often leaves obvious scars in the neck which seriously affects the postoperative quality of life of patients The previous studies have shown that endoscopy-assisted surgery with external cervical approach can achieve oncologic effects similar to traditional open surgery in the treatment of N1b papillary thyroid cancer and can obtain better aesthetic results However endoscopic surgery still has some shortcomings such as poor exposure of some surgical areas and difficult operation Since November 2016 the investigators tried to apply modified transaxillary robotic-assisted surgery technology to the treatment of thyroid papillary carcinoma in China The preliminary study included 30 patients and the results showed that robot-assisted surgery via combined transaxillary-retroaural approach in the treatment of N1b papillary thyroid carcinoma achieved a good oncologic effect 5-year overall survival rate was 1000 As the surgical techniques improved now the investigators can complete robotic-assisted lateral neck lymph node dissection via single-incision transaxillary approach However there is still a lack of high-quality evidence on the long-term oncologic outcome and quality of life of this procedure In this study a prospective multi-center randomized controlled study was conducted to compare the safety long-term oncologic outcomes and postoperative quality of life of the robot-assisted surgery via single-incision transaxillary approach and open surgery in the treatment of N1b papillary thyroid cancer which may provide an alternative for the patients with N1b papillary thyroid cancer
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None