Radiofrequency Ablation of Low Risk Papillary Thyroid Microcarcinoma (RFAforPTMC)

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Seoul National University

Status

Enrolling

Conditions

Papillary Thyroid Microcarcinoma
Thyroid Cancer

Treatments

Procedure: RFA for PTMC

Study type

Interventional

Funder types

Other

Identifiers

NCT03432299
SNUH-RFA-PTMC

Details and patient eligibility

About

This is a single center prospective clinical trial with regard to efficacy and safety of radiofrequency ablation of papillary thyroid microcarcinoma.

Full description

For treatment of papillary thyroid microcarcinoma (PTMC), radiofrequency ablation (RFA) will be performed with the supine position and neck extended under ultrasonogrphic guidance. Before RFA, local anesthesia will be performed. RFA system including radiofrequency generator (VIVA RF system, STARmed, Goyang-si, Korea) and internally cooled electrode (star RF electrode, STARmed, Goyang-si, Korea) will be used. With regard to RFA procedure, moving shot technique and hydrodissection, if indicated, will be used. After RFA, follow-up will be performed using ultrasonography, serum thyroid function test, and questionnaire for quality of life by face-to-face interview at 2 months, 6, 12, 18, 24 months during the first 2 years after RFA, and yearly afterwards.

Enrollment

100 estimated patients

Sex

All

Ages

19 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • who agrees to the consent form
  • aged from 19 to 60 years old
  • who has been diagnosed with Bethesda category V or VI by fine needle aspiration or needle biopsy
  • whose thyroid cancer is 1 cm or smaller than 1 cm length
  • who does not have lymph node or distant metastasis
  • whose thyroid cancer does not have extrathyroidal extension
  • in whom it seems technically possible to completely ablate thyroid cancer using RF

Exclusion criteria

  • who cannot routinely followed up according to the study schedule
  • who has been with Bethesda category I, II, III, or IV by fine needle aspiration or needle biopsy.
  • who has hyperthyroidism that requires treatment
  • who has bleeding tendency
  • multifocal papillary thyroid microcarcinoma
  • who is pregnant

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

RFA for PTMC
Experimental group
Description:
Group who will undergo RFA after diagnosis of PTC
Treatment:
Procedure: RFA for PTMC

Trial contacts and locations

1

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Central trial contact

Ji-hoon Kim, MD,Ph.D

Data sourced from clinicaltrials.gov

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