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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Pregnant or breastfeeding women

Previous alcohol use

Patients on anti-vitamin K anticoagulants

Patients on direct oral anticoagulants

Trial design

Design model

Single group

Treatments tested in this trial

  • Fine needle aspiration biopsy (FNAB)

    Procedure/Surgery

    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)

Treatment groups

180 Participants
are divided into 1 treatment group
Group A: Patients with nodules treated by thermal ablationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cytological change after thermoablation, as described by the 2017 Bethesda classification in six classes, scale ranging from I to VI.

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.

Time frame
Day of the Fine Needle Aspiration Biopsy

Secondary outcomes

1

Ultrasound description of the nodule: size (length x width x thickness)

Time frame
Day of the Fine Needle Aspiration Biopsy
2

Ultrasound description of the nodule: volume (length x width x thickness)

Time frame
Day of the Fine Needle Aspiration Biopsy
3

Ultrasound description of the nodule: echogenicity, as compared with the adjacent thyroid and muscular tissues

Time frame
Day of the Fine Needle Aspiration Biopsy
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.