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

Chinese PLA General Hospital1,021 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,021

Conditions

Papillary Thyroid Cancer

Interventions

thyroid lobectomyPROCEDURE

thyroid lobectomy

image-guided thermal ablationPROCEDURE

radiofrequency ablation or microwave ablation or laser ablation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

disease progression

cervical lymph node metastases, recurrent tumors and persistent tumors

Time frame: more than 5 years

disease-free survival

disease-free survival calculated from treatment initiation to disease progression or the last follow-up date

Time frame: more than 5 years

Secondary Outcomes

complications

complications after surgery or ablation

Time frame: 1 week

procedure time

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.

Time frame: 1 hour after treatment

cost

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

Time frame: 1 week

estimated blood loss

estimated blood loss after surgery or ablation

Time frame: 1 hour

hospitalization

hospitalization for surgery or ablation

Time frame: 1 week

Data from ClinicalTrials.gov

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