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

Papillary Thyroid Cancer Clinical Trial

Official title:

Long-term Comparison of Image-guided Thermal Ablation vs. Lobectomy for Solitary Papillary Thyroid Microcarcinoma: A Multicenter Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06325787
• Other study ID #: S2021-211-02
• Status: Completed
• Phase: N/A
• Start date: May 1, 2013
• Est. completion date: January 31, 2024

Study information

• Verified date: March 2024
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1021
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Papillary Thyroid Cancer
• Thyroid Cancer, Papillary
• Thyroid Diseases

Intervention

Procedure:
• thyroid lobectomy
thyroid lobectomy
• image-guided thermal ablation
radiofrequency ablation or microwave ablation or laser ablation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease progression	cervical lymph node metastases, recurrent tumors and persistent tumors	more than 5 years
Primary	disease-free survival	disease-free survival calculated from treatment initiation to disease progression or the last follow-up date	more than 5 years
Secondary	complications	complications after surgery or ablation	1 week
Secondary	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.	1 hour after treatment
Secondary	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	1 week
Secondary	estimated blood loss	estimated blood loss after surgery or ablation	1 hour
Secondary	hospitalization	hospitalization for surgery or ablation	1 week