Image-guided Thermal Ablation vs. Lobectomy for Solitary Papillary Thyroid Microcarcinoma

Not Applicable

Completed

• Conditions: Papillary Thyroid Cancer
• Interventions: Procedure: image-guided thermal ablation; Procedure: thyroid lobectomy

• Registration Number: NCT06325787
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

To evaluate the clinical outcomes of image-guided thermal ablation versus thyroid lobectomy for the treatment of papillary thyroid microcarcinoma

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-01
• Primary Completion: 2017-01-31
• Study Completion: 2024-01-31
• Status Verified: 2024-03
• Study First Submitted: 2024-03-16
• Study First Submitted QC: 2024-03-16
• Last Update Submitted: 2024-03-21
• Study First Posted: 2024-03-22
• Last Update Posted: 2024-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1021

Inclusion Criteria

1. solitary papillary thyroid carcinoma confirmed by fine-needle aspiration or core-needle biopsy;
2. largest diameter ≤10 mm;
3. no evidence of extrathyroidal extension( no signs of unsmooth thyroid capsule or involvement of the perithyroidal tissue) on ultrasound;
4. no evidence of cervical lymph node metastasis on US or neck CT;
5. no distant metastasis on chest CT;
6. no history of neck irradiation.

Exclusion Criteria

• (1)aggressive subtype of papillary thyroid microcarcinoma confirmed by biopsy(1); (2)multiple tumors; (3) incomplete data or lost follow-up

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
image-guided thermal ablation	image-guided thermal ablation	radiofrequency ablation or microwave ablation
lobectomy	thyroid lobectomy	thyroid lobectomy, is recommended as first-line treatment for papillary thyroid micraocarcinima

Primary Outcome Measures

Name	Time	Method
disease-free survival	more than 5 years	disease-free survival calculated from treatment initiation to disease progression or the last follow-up date
disease progression	more than 5 years	cervical lymph node metastases, recurrent tumors and persistent tumors

Secondary Outcome Measures

Name	Time	Method
complications	1 week	complications after surgery or ablation
cost	1 week	The ablation cost included preoperative examinations, treatment, local anesthesia and ablation needle costs. The lobectomy cost included preoperative examinations, treatment, general anesthesia, hospital bed, nursing and postoperative medication
hospitalization	1 week	hospitalization for surgery or ablation
procedure time	1 hour after treatment	Ablation procedure time was defined from US evaluation for the design of insertion way to treatment terminated. Lobectomy procedure time was defined from incision to closure, not including the anesthesia time.
estimated blood loss	1 hour	estimated blood loss after surgery or ablation