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

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

Treatments tested in this trial

  • Fine needle aspiration biopsy (FNAB)

Treatment groups

180 Participants
are divided into 1 treatment group

Locations

1
Hospital Pitié-Salpêtrière - Department of Thyroid and Endocrine Tumour Pathologies75651, Paris France

Sponsors and collaborators

Assistance Publique - Hôpitaux de Paris

Lead sponsor