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

Completed

• Conditions: Thyroid Cancer; Papillary Thyroid Microcarcinoma
• Interventions: Procedure: Thermal ablation; Procedure: Thyroid lobectomy

• Registration Number: NCT06583057
• Lead Sponsor: Chinese PLA General Hospital

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.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-31
• Study First Submitted: 2024-08-23
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-01
• Last Update Submitted: 2024-09-01
• Study First Posted: 2024-09-03
• Last Update Posted: 2024-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1. a unifocal papillary thyroid carcinoma (PTC) diagnosed by fine-needle aspiration or core-needle biopsy;
2. tumor with a maximum diameter of ≤ 10 mm detected on ultrasound;
3. tumor located within ≤ 2mm from the thyroid capsule (with or without tumor-associated capsular bulging or capsular discontinuity);
4. absence of clinical or imaging evidence of gross ETE (involvement of strap muscles, obtuse angles between the tumor and trachea/esophagus, protrusion into the tracheoesophageal groove, and invasion into other neck structures);
5. no clinical or imaging evidence suggesting lymph node metastasis or distant metastasis

Exclusion Criteria

1. aggressive subtypes of PTC (aggressive subtypes of PTC includes the tall cell, columnar cell, solid, and hobnail variants);
2. multifocal PTMC;
3. history of neck surgery or TA;
4. a follow-up period of < 24 months;
5. incomplete follow-up data, or poor-quality pre-treatment ultrasound images

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Thermal ablation group	Thermal ablation	Patients with clinical T1aN0M0 subcapsular papillary thyroid carcinoma who underwent thermal ablation for treatment.
Thermal ablation group	Thyroid lobectomy	Patients with clinical T1aN0M0 subcapsular papillary thyroid carcinoma who underwent thermal ablation for treatment.
Thyroid lobectomy group	Thermal ablation	Patients with clinical T1aN0M0 subcapsular papillary thyroid carcinoma who underwent thyroid lobectomy for treatment.
Thyroid lobectomy group	Thyroid lobectomy	Patients with clinical T1aN0M0 subcapsular papillary thyroid carcinoma who underwent thyroid lobectomy for treatment.

Primary Outcome Measures

Name	Time	Method
Progression-free survival	From date of enrollment of the first patient until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months	Interval between the date of treatment and the date of detection of disease progression or last follow-up.

Secondary Outcome Measures

Name	Time	Method
Complication	From date of treatment until the date of first documented complication, assessed up to 24 months	Complications included hoarseness, infection, hematoma, airway obstruction, and permanent hypoparathyroidism.

Trial Locations

Locations (1)

ChinaPLAGH; 🇨🇳 Beijing, Beijing, China