Skip to main content
OpenTrials
Completed

NCT Number: NCT06583057

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

To compare the clinical outcomes of Thermal ablation with those of thyroid lobectomy in patients with subcapsular papillary thyroid microcarcinoma.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ChinaPLAGH

Beijing, Beijing Municipality, 100853, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • a unifocal papillary thyroid carcinoma (PTC) diagnosed by fine-needle aspiration or core-needle biopsy;
  • tumor with a maximum diameter of ≤ 10 mm detected on ultrasound;
  • tumor located within ≤ 2mm from the thyroid capsule (with or without tumor-associated capsular bulging or capsular discontinuity);
  • 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);
  • no clinical or imaging evidence suggesting lymph node metastasis or distant metastasis

Exclusion criteria

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

Treatment and study plan

Thermal ablation

Procedure

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.

Other names: Ablation technique

Thyroid lobectomy

Procedure

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.

Primary outcomes

  1. Progression-free survival

    Time frame: 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 outcomes

  1. Complication

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Sep 3, 2024
Registry last updated
Sep 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.