NCT06583057

Multicenter Comparison of Thermal Ablation Versus Thyroid Lobectomy for Subcapsular Papillary Thyroid Microcarcinoma

Multicenter Comparison of Thermal Ablation Versus Thyroid Lobectomy for Subcapsular Papillary Thyroid Microcarcinoma: a Retrospective Cohort Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (actual)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Thyroid Cancer
• Papillary Thyroid Microcarcinoma

Interventions

Type	Name	Description
PROCEDURE	Thermal ablation	Patients who underwent thermal ablation were performed in the outpatient clinic's operating room under local anesthesia. Thermal ablation was performed under real-time ultrasound-guided. The 18-G bipolar radiofrequency applicator with a 0.9 cm active tip (CelonProSurge micro 100-T09, Olympus Surgical Technologies Europe) , or a 16-G/17-G cooled microwave antenna with a 0.3 cm tip (ECO-100A1, YIGAO MWA system Co., Ltd; KY-2000, Kangyou Medical, Nanjing, China) was used during ablation.
PROCEDURE	Thyroid lobectomy	Patients who underwent thyroid lobectomy were performed in the operating theater under general anesthesia. Lobectomy (or lobectomy plus isthmusectomy) with prophylactic central neck dissection were performed.

Timeline

• Start date: 2019-01-01
• Primary completion: 2024-07-01
• Completion: 2024-07-31
• First posted: 2024-09-03
• Last updated: 2024-09-03

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study
• FDA-regulated device study