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

March 21, 2024 updated by: Yu-kun Luo, Chinese PLA General Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1021

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: lobectomy
thyroid lobectomy, is recommended as first-line treatment for papillary thyroid micraocarcinima
Procedure: thyroid lobectomy
thyroid lobectomy
Experimental: image-guided thermal ablation
radiofrequency ablation or microwave ablation
Procedure: image-guided thermal ablation
radiofrequency ablation or microwave ablation or laser ablation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complications
Time Frame: 1 week
complications after surgery or ablation
1 week
procedure time
Time Frame: 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.
1 hour after treatment
cost
Time Frame: 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
1 week
estimated blood loss
Time Frame: 1 hour
estimated blood loss after surgery or ablation
1 hour
hospitalization
Time Frame: 1 week
hospitalization for surgery or ablation
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2013

Primary Completion (Actual)

January 31, 2017

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

March 16, 2024

First Submitted That Met QC Criteria

March 16, 2024

First Posted (Actual)

March 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2021-211-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available because of the patients privacy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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