Ultrasound and Cytological Evaluation 3 Years After Radiofrequency Thermal Ablation of Benign Thyroid Nodules : a Prospective Exploratory Cohort of 180 Nodules

Not Applicable

Not yet recruiting

• Conditions: Thermal Ablation; Fine Needle Aspiration Biopsy; Thyroid Nodules
• Interventions: Procedure: Fine needle aspiration biopsy (FNAB)

• Registration Number: NCT05726981
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

There is no scientific data on post-thermal ablation cytological aspects, but treated nodules that grow back significantly after a procedure justify a new cytology in order not to ignore a neoplastic process.

The EU-TIRADS classification usually used to stratify the risk of cancer (and to justify a fine needle aspiration biopsy) of thyroid nodules is not validated for nodules treated by thermal ablation (TA) (post-RF nodules). However, these nodules often acquire ultrasound criteria of suspicion making it necessary to develop an ultrasound stratification of the risk of malignancy specific to nodules treated by TA.

The objective of this work is to describe the ultrasound and cytological aspects of these treated nodules by performing a systematic assessment at 3 years after thermal ablation including systematic neck ultrasound and fine needle aspiration biopsy. Thus, an ultrasound and cytological atlas (Bethesda classification 2017) of nodules treated by thermal ablation will be constituted.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-12
• Study Start: 2023-02
• Study First Submitted QC: 2023-02-03
• Last Update Submitted: 2023-02-03
• Study First Posted: 2023-02-14
• Last Update Posted: 2023-02-14
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. Patients > 18 years old
2. Carrier of a benign thyroid nodule that has undergone radiofrequency thermoablation 36 months previously ± 12 months, whether the nodule is stable, progressing or decreasing in volume during the screening period and/or on the day of inclusion.
3. Obtaining written informed consent
4. Affiliation to a social security system (excluding AME)

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Exclusion Criteria

1. Pregnant or breastfeeding women
2. Previous alcohol use
3. Patients on anti-vitamin K anticoagulants
4. Patients on direct oral anticoagulants
5. Persons deprived of liberty by judicial or administrative decision
6. Persons under forced psychiatric care
7. Persons admitted to a health or social institution for purposes other than research
8. Persons of full age who are under legal protection (guardianship or curatorship)
9. Persons unable to express their consent
10. Persons under a legal protection measure (there can be no derogation for this category)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with nodules treated by thermal ablation	Fine needle aspiration biopsy (FNAB)	The study population is a monocentric cohort of patients who underwent thermoablation treatment for benign thyroid nodules 3 years ago. These patients aged \>18 years-old were carriers of a benign but troublesome thyroid nodule before thermal ablation, either unique or "dominant", i.e. associated with one or more other non-significant nodules (\<20 mm) that were subjected to simple ultrasound surveillance. Patients refused, after clear and fair information, surgical management of their nodule. On average, 2 patients have been treated for TA per week in the Thyroid Disease and Endocrine Tumor Department since 2016. Patients systematically benefit from annual clinical and ultrasound monitoring as part of their follow-up in our Department.

Primary Outcome Measures

Name	Time	Method
Cytological change after thermoablation, as described by the 2017 Bethesda classification in six classes, scale ranging from I to VI.	Day of the Fine Needle Aspiration Biopsy	Cytological result of the nodule 3 years after thermoablation, the result of which is given according to the 2017 Bethesda classification in six classes ranging from I to VI.

Secondary Outcome Measures

Name	Time	Method
Ultrasound description of the nodule: volume (length x width x thickness)	Day of the Fine Needle Aspiration Biopsy
Ultrasound description of the nodule: echogenicity, as compared with the adjacent thyroid and muscular tissues	Day of the Fine Needle Aspiration Biopsy
Ultrasound description of the nodule: echostructure, measured as the percentage of liquid volume compared to nodule's total volume	Day of the Fine Needle Aspiration Biopsy
Ultrasound description of the nodule: size (length x width x thickness)	Day of the Fine Needle Aspiration Biopsy