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

NCT06316895 | Recruiting

• 1 other identifier: S2023-706
• Study Type: observational
• Target: 3,772
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To evaluate the clinical outcomes of ultrasound-guided thermal ablation and thyroid surgery for the treatment of papillary thyroid carcinoma;
2. 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;

Conditions

Papillary Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• rate of disease progression

  cervical lymph node metastases, recurrent tumors and persistent tumors

  more than 5 year

Secondary Outcomes (2)

• Rate of complications

  1week

• Rate of tumor disappearance

  2 year

Study Arms (2)

surgery group

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

Procedure: thyroid surgery

ablation group

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

Procedure: ultrasound-guided thermal ablation

Interventions

thyroid surgery PROCEDURE

thyroid lobectomy

surgery group

ultrasound-guided thermal ablation PROCEDURE

radiofrequency ablation; microwave ablation or laser ablation

ablation group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with low-risk papillary thyroid carcinoma who choose surgery or thermal ablation

You may qualify if:

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

You may not qualify if:

• patients with convincing evidence of aggressive papillary thyroid carcinoma or other type of thyroid cancer by biopsy
• history of neck radiation
• history of thyroid surgery
• coagulation disorder
• serious heart, respiratory, liver, or renal failure
• dysfunction of the vocal cord on the opposite side

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Thyroid Cancer, Papillary

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Yukun Luo

  Chinese PLA General Hospital

  STUDY CHAIR

Central Study Contacts

Lin Yan, MD

CONTACT

13811237313; gemma-y@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Department of Ultrasound

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: March 19, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)