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

NCT06583057 | Completed DMC FDA Drug FDA Device

• 1 other identifier: S2019-211-01
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Thyroid Cancer; Papillary Thyroid Microcarcinoma

Keywords

Thermal ablation; Lobectomy; Ultrasound; Papillary thyroid microcarcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Interval between the date of treatment and the date of detection of disease progression or last follow-up.

  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

Secondary Outcomes (1)

• Complication

  From date of treatment until the date of first documented complication, assessed up to 24 months

Study Arms (2)

Thermal ablation group

Patients with clinical T1aN0M0 subcapsular papillary thyroid carcinoma who underwent thermal ablation for treatment.

Procedure: Thermal ablation; Procedure: Thyroid lobectomy

Thyroid lobectomy group

Patients with clinical T1aN0M0 subcapsular papillary thyroid carcinoma who underwent thyroid lobectomy for treatment.

Procedure: Thermal ablation; Procedure: Thyroid lobectomy

Interventions

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.

Also known as: Ablation technique

Thermal ablation group; Thyroid lobectomy group

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.

Thermal ablation group; Thyroid lobectomy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study included patients with clinical T1aN0M0 PTC who underwent thermal ablation or thyroid lobectomy at three institutions between June 2014 and December 2020.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

ChinaPLAGH

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Thyroid Neoplasms; Papillary Thyroid Microcarcinoma

Interventions

Transurethral Resection of Prostate; Ablation Techniques

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of ultrasound

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: September 3, 2024
• Study Start: January 1, 2019
• Primary Completion: July 1, 2024
• Study Completion: July 31, 2024
• Last Updated: September 3, 2024

Record last verified: 2024-09

Locations

CN (1)