The Clinical Outcomes and Prediction of Thermal Ablation for Low-risk Papillary Thyroid Carcinoma

NCT ID: NCT06316895

Last Updated: 2024-12-11

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

RECRUITING

Total Enrollment

3772 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-01

Study Completion Date

2029-12-31

Brief Summary

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1. To evaluate the clinical outcomes of ultrasound-guided thermal ablation and thyroid surgery for the treatment of papillary thyroid carcinoma;
2. To develop and validate a artificial intelligence model to predict the outcomes of ultrasound-guided thermal ablation in the treatment of papillary thyroid carcinoma;

Detailed Description

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Conditions

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Papillary Thyroid Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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surgery group

patients with low-risk papillary thyroid carcinoma who chose thyroid surgery

thyroid surgery

Intervention Type PROCEDURE

thyroid lobectomy

ablation group

patients with low-risk papillary thyroid carcinoma who chose thermal ablation

ultrasound-guided thermal ablation

Intervention Type PROCEDURE

radiofrequency ablation; microwave ablation or laser ablation

Interventions

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thyroid surgery

thyroid lobectomy

Intervention Type PROCEDURE

ultrasound-guided thermal ablation

radiofrequency ablation; microwave ablation or laser ablation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. patients age between 18 and 80 year old, both sex
2. papillary thyroid carcinoma confirmed by core-needle biopsy or fine-needle aspiration
3. the largest diameter ≤2.0 cm
4. no clinical or imaging evidences of extrathyroidal extension, lymph node metastasis and distant metastasis on ultrasound, nech and chest CT
5. follow-up period ≥12 months,

Exclusion Criteria

1. patients with convincing evidence of aggressive papillary thyroid carcinoma or other type of thyroid cancer by biopsy
2. history of neck radiation
3. history of thyroid surgery
4. coagulation disorder
5. serious heart, respiratory, liver, or renal failure
6. dysfunction of the vocal cord on the opposite side
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 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

Principal Investigators

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Yukun Luo

Role: STUDY_CHAIR

Chinese PLA General Hospital

Locations

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Chinese PLA General Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lin Yan, MD

Role: CONTACT

Phone: 13811237313

Email: [email protected]

Other Identifiers

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S2023-706

Identifier Type: -

Identifier Source: org_study_id