Ultrasound-Guided Microwave Ablation Vs. Surgery for Low-Risk PapilaryThyroid Carcinoma

Recruiting

• Conditions: Thyroid Cancer, Papillary

• Registration Number: NCT06725576
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary

This study aims to investigate the efficacy and prognosis of ultrasound-guided and gene-based microwave ablation (MWA) versus surgical treatment in patients with low-risk papillary thyroid carcinoma (PTC). By analyzing genetic testing results, the study explores the impact of genetic mutations on treatment selection for low-risk patients, providing more precise molecular biological evidence for treatment choices and prognosis evaluation of thyroid cancer. This prospective study collects clinical data from patients diagnosed with PTC at Sun Yat-sen Memorial Hospital of Sun Yat-sen University between January 2022 and November 2024, who underwent genetic testing prior to treatment, and assesses efficacy and complications through long-term follow-up.

Detailed Description

Objective: This study evaluates and compares the efficacy and prognosis of ultrasound and gene-based microwave ablation (MWA) and surgical treatment in patients with low-risk papillary thyroid carcinoma (PTC), emphasizing the influence of genetic mutations on low-risk patients' selection.

Background: MWA, a minimally invasive technique, is increasingly recognized in the management of PTC. While traditional criteria for ablation focus on tumor size, number, and location, the impact of genetic mutations on treatment efficacy remains underexplored.

Methods: A total of 201 patients with low-risk PTC without metastasis were prospectively enrolled. All patients underwent ultrasound and next-generation sequencing to confirm low-risk status. Patients chose either ablation or surgery and were monitored until November 2024. Efficacy and complications were assessed using thyroid ultrasound and contrast-enhanced ultrasound.

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2024-12-05
• Study First Posted: 2024-12-10
• Last Update Submitted: 2024-12-25
• Last Update Posted: 2024-12-31
• Primary Completion: 2025-03-04
• Study Completion: 2025-03-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 201

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease progression	through study completion, an average of 1 year	The primary endpoint was disease progression, defined as: (1) local recurrence or cervical lymph node metastasis confirmed by FNA; (2) Distant organ metastasis; (3) Death due to tumor progression.

Secondary Outcome Measures

Name	Time	Method
Complications	through study completion, an average of 1 year	Such as permanent or transient hypoparathyroidism, recurrent laryngeal nerve injury, postoperative hypertension, infection, fever, pain, and nausea or vomiting. Permanent hypoparathyroidism was defined as the need for calcium or vitamin D supplementation beyond six months, while transient hypoparathyroidism indicated recovery within six months. Permanent recurrent laryngeal nerve injury was defined as persistent voice changes beyond six months, while transient injury indicated recovery within six months.
Treatment costs	through study completion, an average of 1 year	Including preoperative tests and treatment costs
Time of hospital stay	from admission to discharge, up to 1 week.	The total duration of hospital stay from admission to discharge.
Operative time	immediately after the intervention	Time from the start of surgery to the completion of surgery.
Ablation efficacy	Follow-up examination one month after treatment.	Defined as complete or incomplete ablation based on Contrast-enhanced ultrasound (CEUS).
Changes in ablation zone volume	through study completion, an average of 1 year	Measured before and after treatment
Thyroid function	through study completion, an average of 1 year	The proportion of patients with thyroid dysfunction after treatment.

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China