Endocrine Abstracts

JOINT904

Introduction: Preoperative risk stratification in differentiated thyroid cancer (DTC) remains a considerable challenge for endocrinology. Sonographic evaluation of the tumor before surgery may help with optimal planning of the thyroid surgery extent. However, no data are available for the estimation of its sensitivity and specificity. Thus, we plan to perform a prospective clinical trial to define the accuracy of preoperative sonographic differentiation between low risk and higher risk DTC. For the appropriate planning, we first performed a retrospective study to determine the sonographic features necessary for the preoperative diagnosis of low-risk DTC. We found that there was a possibility to apply sonographic diagnosis. This study was reported during ECE 2024. Based on the univariate analysis of feature sensitivity, we prepared a multifeature predictive classifier (MPC), which requires a prospective validation in our clinical trial.

Aim: The primary objective of the study is to evaluate the preoperative sonographic criteria based on MPC in a prospective clinical trial. During the trial, the thyroid tumor with DTC suspicion or DTC diagnosis will be evaluated by sonography to calculate MPC, in aim to allow planning lobectomy for low-risk thyroid cancer. For adequate trial planning, we needed to estimate the following data: 1. what is the predictive positive value of MPC, compared to a single ultrasonographic feature? 2. How many patients should be recruited? 3. How long will the trial last?

Methods: On the basis of our retrospective results, we plan to evaluate the predictive value of selected sonography features: lesion diameter, its ill-defined or irregular margins and vascularity in CD option. On the basis of these sonographic results, the MPC will be calculated, and its positive predictive value will be evaluated in the context of postoperative histopathological stratification.

Results: In our center, the proportion of low risk to higher risk patients is 65% and 35%. We expect that the trial should give at least 10% difference between positive predictive values (PPV of MPC), compared to the ultrasonographic criteria specified above. Thus, we should recruit 1000 patients with intermediate or high risk DTC during the trial. Taking into account the numbers of patients coming to our center in 2019 -2021, we expect that the trial will last circa 32 months.

Conclusions: The results of our analysis indicate that the planned clinical trial is feasible in our center.