NCT06325787

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,021

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2017

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 22, 2024

Completed
Last Updated

March 25, 2024

Status Verified

March 1, 2024

Enrollment Period

3.8 years

First QC Date

March 16, 2024

Last Update Submit

March 21, 2024

Conditions

Papillary Thyroid Cancer

Outcome Measures

Primary Outcomes (2)

  • disease progression

    cervical lymph node metastases, recurrent tumors and persistent tumors

    more than 5 years

  • disease-free survival

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

    more than 5 years

Secondary Outcomes (5)

  • complications

    1 week

  • procedure time

    1 hour after treatment

  • cost

    1 week

  • estimated blood loss

    1 hour

  • hospitalization

    1 week

Study Arms (2)

lobectomy

ACTIVE COMPARATOR

thyroid lobectomy, is recommended as first-line treatment for papillary thyroid micraocarcinima

Procedure: thyroid lobectomy

image-guided thermal ablation

EXPERIMENTAL

radiofrequency ablation or microwave ablation

Procedure: image-guided thermal ablation

Interventions

thyroid lobectomyPROCEDURE

thyroid lobectomy

lobectomy
image-guided thermal ablationPROCEDURE

radiofrequency ablation or microwave ablation or laser ablation

image-guided thermal ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Thyroid Cancer, Papillary

Condition Hierarchy (Ancestors)

Adenocarcinoma, PapillaryAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsThyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of Department of Ultrasound

Study Record Dates

First Submitted

March 16, 2024

First Posted

March 22, 2024

Study Start

May 1, 2013

Primary Completion

January 31, 2017

Study Completion

January 31, 2024

Last Updated

March 25, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

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