Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510030, China
Location status: Recruiting
Location contact
Miaoyun Long, MD
CONTACT
Yuxin Shen, MBBS
CONTACT
NCT Number: NCT06725576
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Observational
Guangzhou, Guangdong, 510030, China
Location status: Recruiting
Miaoyun Long, MD
CONTACT
Yuxin Shen, MBBS
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
The inclusion criteria of this study were as followed:
The exclusion criteria were as followed:
Low-risk PTC is defined as:
Intermediate-high risk PTC is defined as:
Thyroid ablation performed under ultrasound guidance to treat low-risk papillary thyroid carcinoma.
Time frame: 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.
Time frame: 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.
Time frame: through study completion, an average of 1 year
Including preoperative tests and treatment costs
Time frame: from admission to discharge, up to 1 week.
The total duration of hospital stay from admission to discharge.
Time frame: immediately after the intervention
Time from the start of surgery to the completion of surgery.
Time frame: Follow-up examination one month after treatment.
Defined as complete or incomplete ablation based on Contrast-enhanced ultrasound (CEUS).
Time frame: through study completion, an average of 1 year
Measured before and after treatment
Time frame: through study completion, an average of 1 year
The proportion of patients with thyroid dysfunction after treatment.
Contact information is provided by the study sponsor or research team.
Miaoyun Long, MD
CONTACT
Yuxin Shen, MBBS
CONTACT
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Other
Ultrasound and Gene-Guided Microwave Ablation Versus Surgery for Low-Risk Papillary Thyroid Carcinoma: a Prospective Observational Cohort Study.
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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.
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