Discussion
tumors
EVENT, TUMORS, SECONDARY, PND, PATHOLOGY
The main objective of this study is to show the non-inferiority of total thyroidectomy alone as compared to a total thyroidectomy with a bilateral prophylactic central neck dissection in clinically low-risk patients. This trial will ultimately include a number of patients with intermediate risk factors (Haugen) found on finally pathology. This is the rationale for administering an ablative dose of RAI to all patients, despite the fact that RAI is no longer systematically indicated for pathologically low-risk tumors.(Leboulleux 2022). A secondary objective, however, is to also compare the thyroglobulin levels 8 weeks after surgery and before administration of RAI in each group, to evaluate outcomes without RAI. The need for a total thyroidectomy for low-risk tumors has also been questioned (Haugen); unfortunately, this clinical trial is designed only to answer one question, that is, the utility of PND, and is not suited to answer other questions concerning “downgrading” of surgery for low-risk tumors.Centers not including patients may be subjected to closing. Centers in France and outside of France may be added as investigators, subjected to approval of an amendment to the study by the national authorities (National Agency for Drug Safety, “Agence Nationale de la Sécurité du Médicament et des Produits de Santé, ANSM) and the French nationa research ethics committee (Comité de Protection des Personnes, CPP). In the event of other amendments, they will also be subjected to the above-cited national authorities for safety and ethical evaluation. The promotor data managing committee will communicate any approved protocol modifications to the participating centers.