NCT05758038

Brief Summary

To evaluate the clinical outcomes of RFA and MWA for benign thyroid nodules treatment

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

1.8 years

First QC Date

February 12, 2023

Last Update Submit

March 4, 2023

Conditions

Thyroid Nodule (Benign)

Outcome Measures

Primary Outcomes (3)

  • symptoms score

    symptoms score will be assessed by (visual analogue scale) a score from 1 to 10 will be given by the patient according to each symptom including (neck pain , dysphagia , foreign body sensation , discomfort and cough) 1 is the minimum score indicating the best outcome and 10 is the maximum score indicating worst outcome

    2 years

  • thyroid nodule volume reduction

    volume reduction ratio VRR assessed by Ultrasound = \[(initial volume - final volume)/initial volume\] x 100.

    2 years

  • cosmetic score

    cosmetic score will be measured by the physician (1, no palpable mass; 2, no cosmetic problem but palpable mass; 3, a cosmetic problem on swallowing only; and 4, a readily detected cosmetic problem) 1 indicates the best outcome and 4 indicates the worst outcome

    2 years

Study Arms (2)

group 1

Patients with benign thyroid nodules undergo RFA

Procedure: Radiofrequency ablation/Microwave ablation

group 2

Patients with benign thyroid nodule undergo MWA

Procedure: Radiofrequency ablation/Microwave ablation

Interventions

Radiofrequency ablation/Microwave ablationPROCEDURE

thermal ablation by radiofrequency and Microwave

group 1group 2

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with benign thyroid nodules come to assiut university hospital for treatment

You may qualify if:

  • Solid or mixed nodules with predominant solid component with benign pathological result from US guided fine needle aspiration (FNAC).
  • Symptomatic and/or cosmetic problems.
  • Clinical thyrotoxicosis and hyperthyroidism caused by autonomously functioning thyroid nodules (AFTNs)
  • Refusal or ineligible for surgery.
  • Anxiety about a malignant transformation.

You may not qualify if:

  • Malignant nodules on US.
  • Cytological evidence for malignancy
  • Patients with abnormal coagulation profile.
  • previous surgery or medicine for the thyroid, and vocal cord palsy in the side contralateral to the target nodules.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Russ G, Ben Hamou A, Poiree S, Ghander C, Menegaux F, Leenhardt L, Buffet C. Learning curve for radiofrequency ablation of benign thyroid nodules. Int J Hyperthermia. 2021;38(1):55-64. doi: 10.1080/02656736.2021.1871974.

    PMID: 33491515BACKGROUND

  • Liu YJ, Qian LX, Liu D, Zhao JF. Ultrasound-guided microwave ablation in the treatment of benign thyroid nodules in 435 patients. Exp Biol Med (Maywood). 2017 Sep;242(15):1515-1523. doi: 10.1177/1535370217727477. Epub 2017 Aug 28.

    PMID: 28847173BACKGROUND

  • Erturk MS, Cekic B, Celik M. Microwave Ablation of Benign Thyroid Nodules: Effects on Systemic Inflammatory Response. J Coll Physicians Surg Pak. 2020 Jul;30(7):694-700. doi: 10.29271/jcpsp.2020.07.694.

    PMID: 32811597BACKGROUND

  • Deandrea M, Trimboli P, Garino F, Mormile A, Magliona G, Ramunni MJ, Giovanella L, Limone PP. Long-Term Efficacy of a Single Session of RFA for Benign Thyroid Nodules: A Longitudinal 5-Year Observational Study. J Clin Endocrinol Metab. 2019 Sep 1;104(9):3751-3756. doi: 10.1210/jc.2018-02808.

    PMID: 30860579BACKGROUND

MeSH Terms

Conditions

Thyroid Nodule

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Thyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Omar Mokhtar, Assistant lecturer

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Omar Mokhtar, Assistant lecturer

CONTACT

+201094584576ogamalm@aun.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

February 12, 2023

First Posted

March 7, 2023

Study Start

March 1, 2023

Primary Completion

January 1, 2025

Study Completion

March 1, 2025

Last Updated

March 7, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share