Thermal Ablation Vs Thyroidectomy for Large Benign Thyroid Nodules

NCT06607133 | Not Yet Recruiting DMC

• 1 other identifier: S2019-283-02
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the safety, efficacy and quality of life between staged thermal ablation and thyroidectomy in the treatment of Large benign thyroid nodules.

Conditions

Benign Thyroid Nodules

Keywords

thermal ablation; Thyroidectomy

Outcome Measures

Primary Outcomes (2)

• volume reduction ratio

  The volume reduction ratio(VRR) = \[(preoperative volume - volume at the follow-up point)/preoperative volume\] × 100%. The volumes of the nodules were calculated using the following equation: V=π/6 a×b×c (where V is the volume, a is the maximum diameter, b and c are the other two perpendicular diameters).

  From enrollment to the end of treatment at 12 months

• Complications

  Complications related to thermal ablation or thyroidectomy during treatment procedures, at the hospital stay and follow-ups.

  From enrollment to the end of treatment at 12 months

Secondary Outcomes (2)

• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire

  From enrollment to the end of treatment at 12 months

• Thyroid Cancer-Specific Quality of Life questionnaire

  From enrollment to the end of treatment at 12 months

Study Arms (2)

surgery group

patients treated with thyroidectomy for benign thyroid nodules

Procedure: surgery

thermal ablation group

patients treated with staged thermal ablation for benign thyroid nodules

Procedure: staged thermal ablation

Interventions

surgery PROCEDURE

patients undergo conventional/open thyroidectomy or endoscopic thyroidectomy for large benign thyroid nodules

surgery group

staged thermal ablation PROCEDURE

patients undergo multiple sessions of thermal ablation for large benign thyroid nodules

thermal ablation group

Eligibility Criteria

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

Study Population

patients treated with surgery, or staged thermal ablation in China-Japan Friendship Hospital

You may qualify if:

• benign thyroid nodules confirmed by surgical pathology in surgery group, and by two separate US-guided fine-needle aspiration (FNA) or core needle biopsy (CNB) in thermal ablation group;
• the largest diameter of the nodule ≥4 cm;
• the presence of nodule-related symptoms, cosmetic concerns, or psychological stress;
• patients treated with surgery, or staged thermal ablation (who explicitly refused surgery);
• more than 12-month follow-up duration

You may not qualify if:

• suspicion of malignant nodule on ultrasound findings (e.g., marked hypoechoic, microcalcifications, or ill-defined margins);
• comorbidities of other severe diseases;
• without complete treatment and/or follow-up information

Sponsors & Collaborators

• Ming-an Yu: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Interventions

Surgical Procedures, Operative

Central Study Contacts

Ming-an Yu, MD

CONTACT

86-84205756; yma301@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of the Department of Interventional Medicine

Study Record Dates

• First Submitted: September 8, 2024
• First Posted: September 23, 2024
• Study Start: September 10, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)