Ultrasound and Cytological Evaluation 3 Years After Radiofrequency Thermal Ablation of Benign Thyroid Nodules : a Prospective Exploratory Cohort of 180 Nodules
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fine needle aspiration biopsy (FNAB).
- Who it may be relevant to
- Registry conditions: Thermal Ablation, Fine Needle Aspiration Biopsy, Thyroid Nodules. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Fine needle aspiration biopsy (FNAB)
Thyroid FNAB is a minimally invasive procedure performed routinely by an experienced sonographer. It is a safe and brief procedure, performed with a 27G or 25G (very fine) needle (3 needles, i.e. 1 needle per pass)
Primary outcome measures
- Cytological change after thermoablation, as described by the 2017 Bethesda classification in six classes, scale ranging from I to VI. [Time frame: Day of the Fine Needle Aspiration Biopsy]
Secondary outcome measures (4)
- Ultrasound description of the nodule: size (length x width x thickness) [Time frame: Day of the Fine Needle Aspiration Biopsy]
- Ultrasound description of the nodule: volume (length x width x thickness) [Time frame: Day of the Fine Needle Aspiration Biopsy]
- Ultrasound description of the nodule: echogenicity, as compared with the adjacent thyroid and muscular tissues [Time frame: 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 [Time frame: Day of the Fine Needle Aspiration Biopsy]
Eligibility criteria
Inclusion criteria
- Patients > 18 years old
- Carrier of a benign thyroid nodule that has undergone radiofrequency thermoablation 36 months previously ± 12 months +/- 1 month, whether the nodule is stable, progressing or decreasing in volume during the screening period and/or on the day of inclusion.
- Obtaining written informed consent
- Affiliation to a social security system (excluding AME)
Exclusion criteria
- Pregnant or breastfeeding women
- Previous alcohol use
- Patients on anti-vitamin K anticoagulants
- Patients on direct oral anticoagulants
- Persons deprived of liberty by judicial or administrative decision
- Persons under forced psychiatric care
- Persons admitted to a health or social institution for purposes other than research
- Persons of full age who are under legal protection (guardianship or curatorship)
- Persons unable to express their consent
- Persons under a legal protection measure (there can be no derogation for this category)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Hospital Pitié-Salpêtrière - Department of Thyroid and Endocrine Tumour Pathologies — Paris
Identifiers
NCT: NCT05726981 · APHP211436