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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

PTC confirmed by fine-needle aspiration (FNA);

Confirmed low-risk mutation types by next-generation sequencing (NGS) before surgery;

No severe functional diseases, such as heart failure, severe respiratory diseases, or renal failure;

Availability of complete follow-up data.

Disqualifiers

No local or distant metastasis assessed by imaging evaluations, including ultrasound or computed tomography (CT);

Lacking of preoperative genetic testing or inability to assess genetic test results;

Inability to complete follow-up or lost to follow-up during the study.

Maximum tumor diameter ≤1 cm;

Trial population

The study population includes patients diagnosed with papillary thyroid carcinoma (PTC) at Sun Yat-Sen Memorial Hospital from January 2022 to November 2024. A total of 201 patients were prospectively enrolled in this study.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Ablation

    Procedure/Surgery

    Thyroid ablation performed under ultrasound guidance to treat low-risk papillary thyroid carcinoma.

Treatment groups

201 Participants
are divided into 2 treatment groups
Group A: Ablation Group1 intervention
Group B: Surgery Group0 interventions

Trial outcomes

Primary outcomes

1

Disease progression

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

Secondary outcomes

1

Complications

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
2

Treatment costs

Including preoperative tests and treatment costs

Time frame
through study completion, an average of 1 year
3

Time of hospital stay

The total duration of hospital stay from admission to discharge.

Time frame
from admission to discharge, up to 1 week.
4

Operative time

Time from the start of surgery to the completion of surgery.

Time frame
immediately after the intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Lead sponsor

National Natural Science Foundation of China

Collaborator

Guangzhou Science and Technology Innovation Commission,China

Collaborator