Thermal Ablation Vs Thyroidectomy for Large Benign Thyroid Nodules

Comparison of Staged Thermal Ablation and Thyroidectomy for Large Benign Thyroid Nodules

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

Study Overview

• Status: Not yet recruiting
• Conditions: Benign Thyroid Nodules
• Intervention / Treatment: Procedure: surgery; Procedure: staged thermal ablation

Detailed Description

Large benign thyroid nodules （BTNs）usually cause compressive symptoms or cosmetic concerns and therefore require treatment. Thyroidectomy remains the mainstay treatment for large, symptomatic BTNs. However, if surgery is not feasible or refused, ablative approach could be considered in selected patients. However, it has been proved that single application of thermal ablation is less effective in causing shrinkage in large thyroid nodules. The possible reason is that it is difficult for single application of thermal ablation to cover all of the nodule tissue in a three-dimension if the nodule is large. In addition, nodule locations adjacent to vital structures might hinder complete treatment in one session because of safety concerns. Few studies reveal that staged thermal ablation (Pre-designed multiple sessions of thermal ablation) can also achieve complete ablation and adequate volume reduction of large benign thyroid nodules. However, there is a lack of comparison between these two methods. Thus, this study is aimed to compare the safety, efficacy, quality of life between staged thermal ablation and thyroidectomy for treating large benign thyroid nodules.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Ming-an Yu, MD; Phone Number: 86-84205756; Email: yma301@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • China-Japan Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
surgery group; patients treated with thyroidectomy for benign thyroid nodules	Procedure: surgery; patients undergo conventional/open thyroidectomy or endoscopic thyroidectomy for large benign thyroid nodules
thermal ablation group; patients treated with staged thermal ablation for benign thyroid nodules	Procedure: staged thermal ablation; patients undergo multiple sessions of thermal ablation for large benign thyroid nodules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire	Questionnaires of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) was used to evaluate the quality of life for cancer patients. All scales and single-item measures range from score 0-100 after linear transformation. The summary score of QLQ-C30 is used to measure the overall health-related quality-of-life (HRQoL), with a lower score indicating poorer HRQoL. And a higher score on the functional scales and global status scale indicates a better level of functioning and HRQoL, while a higher score on the symptom scales and single item means more discomfort and complaints.	From enrollment to the end of treatment at 12 months
Thyroid Cancer-Specific Quality of Life questionnaire	The Thyroid Cancer-Specific Quality of Life questionnaire (THYCA-QoL) was used to assess thyroid-specific symptoms in thyroid cancer survivors. The questionnaire consists of seven symptom scales (including neuromuscular, voice, concentration, sympathetic, throat/mouth, psychological and sensory problems) and six single items (including problems with scar, feeling chilly, tingling hands/feet, gained weight, headache, less interest in sex). A higher score on this scale implies more symptoms and complaints.	From enrollment to the end of treatment at 12 months

Collaborators and Investigators

• Sponsor: Ming-an Yu

Study record dates

Study Major Dates

• Study Start (Estimated): September 10, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: September 8, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: thermal ablation; Thyroidectomy
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Neoplasms; Thyroid Diseases; Thyroid Nodule
• Other Study ID Numbers: S2019-283-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available because of the patients privacy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No