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

NCT ID: NCT06325787

Last Updated: 2024-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1021 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-01

Study Completion Date

2024-01-31

Brief Summary

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

Detailed Description

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Conditions

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Papillary Thyroid Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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lobectomy

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

Group Type ACTIVE_COMPARATOR

thyroid lobectomy

Intervention Type PROCEDURE

thyroid lobectomy

image-guided thermal ablation

radiofrequency ablation or microwave ablation

Group Type EXPERIMENTAL

image-guided thermal ablation

Intervention Type PROCEDURE

radiofrequency ablation or microwave ablation or laser ablation

Interventions

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thyroid lobectomy

thyroid lobectomy

Intervention Type PROCEDURE

image-guided thermal ablation

radiofrequency ablation or microwave ablation or laser ablation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yu-kun Luo

Director, Head of Department of Ultrasound

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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S2021-211-02

Identifier Type: -

Identifier Source: org_study_id

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