Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-31 @ 12:58 PM
Study NCT ID:
NCT06583057
Status:
COMPLETED
Last Update Posted:
2024-09-03
First Post:
2024-08-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Comparison of Thermal Ablation Versus Thyroid Lobectomy for Subcapsular Papillary Thyroid Microcarcinoma
Sponsor:
Chinese PLA General Hospital
Organization:
Study Overview
Official Title:
Multicenter Comparison of Thermal Ablation Versus Thyroid Lobectomy for Subcapsular Papillary Thyroid Microcarcinoma: a Retrospective Cohort Study
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To compare the clinical outcomes of Thermal ablation with those of thyroid lobectomy in patients with subcapsular papillary thyroid microcarcinoma.
Detailed Description:
The global incidence of papillary thyroid microcarcinoma (PTMC) has increased rapidly in recent decades because of improved ultrasound (US) detection and fine needle aspiration biopsy and has primarily contributed to the surge in cases of thyroid carcinoma. Given the indolent characteristics of most PTMCs, the American Thyroid Association guidelines recommend active surveillance for low-risk PTMC to prevent over-treatment. Nevertheless, in many countries, active surveillance poses challenges, including patient anxiety, limited medical resources, and insurance coverage limitations when adopted. Furthermore, many patients prefer treatment rather than active surveillance due to anxiety, a meta-analysis showed that a significant proportion of patients (8.7%-32%) who underwent delayed surgery without tumor progression during active surveillance. Thyroid lobectomy (TL), replacing total thyroidectomy is recommended as the first-line treatment for PTMC by several guidelines. However, there were still concerns remain regarding lifelong hormone replacement therapy, surgery-related complications, and the potential over-treatment associated with TL.
Thermal ablation (TA) has emerged as a viable alternative for the managing of PTMC within the thyroid gland, as evidenced by studies conducted across various Asian and European countries. It has been endorsed as an alternative treatment strategy to TL in clinical guidelines issued by multiple professional associations in Europe, Asia, and North America. However, controversy persists regarding its usefulness for subcapsular PTMC because of concerns about potential extrathyroidal extension (ETE) or occult lymph node metastasis (LNM), which may impact disease progression post-treatment. There are also technical challenges and safety issues when ablating subcapsular lesions. To date, a limited number of studies have reported the short-term efficacy of TA in treating subcapsular PTMC.However, these studies were constrained by small sample sizes and the absence of comparative analyses between the first-line treatment option, TL, and TA. Consequently, further research is needed to fully understand the role of TA in the therapeutic management of subcapsular PTMC and its potential as an alternative to TL.
Therefore, the aim of this multicenter study was to compare the clinical outcomes of TA with those of TL in patients with subcapsular PTMC.
Thermal ablation (TA) has emerged as a viable alternative for the managing of PTMC within the thyroid gland, as evidenced by studies conducted across various Asian and European countries. It has been endorsed as an alternative treatment strategy to TL in clinical guidelines issued by multiple professional associations in Europe, Asia, and North America. However, controversy persists regarding its usefulness for subcapsular PTMC because of concerns about potential extrathyroidal extension (ETE) or occult lymph node metastasis (LNM), which may impact disease progression post-treatment. There are also technical challenges and safety issues when ablating subcapsular lesions. To date, a limited number of studies have reported the short-term efficacy of TA in treating subcapsular PTMC.However, these studies were constrained by small sample sizes and the absence of comparative analyses between the first-line treatment option, TL, and TA. Consequently, further research is needed to fully understand the role of TA in the therapeutic management of subcapsular PTMC and its potential as an alternative to TL.
Therefore, the aim of this multicenter study was to compare the clinical outcomes of TA with those of TL in patients with subcapsular PTMC.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: