305 [18F]FDG-PET/CT to prevent futile surgery: a blinded, randomised controlled multicentre trial 4 Results After screening 260 patients for eligibility, we finally enrolled 132 patients with a cytologically indeterminate thyroid nodule and scheduled diagnostic thyroid surgery between 1 July 2015 and 16 October 2018 (Figures 1 and 2, Table 2). Their mean age was 54.5 ± 13.6 years; 107 (81.1%) patients were female. Ninety-one (69%) patients were randomly allocated to the [18F]FDG-PET/CT-driven group and 41 (31%) to the diagnostic surgery group. Baseline characteristics, including stratifying variables and PET/CT parameters were balanced across both allocation groups, except for two patient-reported complaints upon first presentation: subjectively increased size of a known thyroid nodule (p=0.01) and dysphagia (p=0.02) (Table 3). Suspicious ultrasound characteristics were present at baseline in 40% (36/91) patients in the [18F]FDG-PET/CT-driven group and 46% (19/41) patients in the diagnostic surgery group (p=0.47). [18F]FDG-PET/CT results showed a visually [18F]FDG-negative index nodule in 41 of 132 (31%) patients: 26 of 91 (29%) in the [18F]FDG-PET/CT-driven group and 15 of 41 (37%) in the diagnostic surgery group (p=0.36). All 26 patients with an [18F]FDG-negative index nodule in the [18F]FDG-PET/CT-driven group were advised active surveillance. After one year, 23 had not undergone surgery. On the one-year ultrasound, 21 of 23 nodules (91%) were unchanged in size and appearance; they were considered benign. Two of 23 (9%) nodules had increased by 28%-37% in largest diameter on the one-year ultrasound. To date, after a median follow-up of 29 months (IQR 24-45) until their latest ultrasound exam, 20 of 23 (87%) nodules have remained unchanged. Three patients, including the two with an apparently growing nodule on the one-year ultrasound, experienced local discomfort attributed to local compression of the nodule and underwent diagnostic surgery outside the study follow-up (20, 35, and 41 months after [18F]FDG-PET/CT, respectively). Histopathology was benign, showing two follicular adenomas and one hyperplastic nodule. All 41 patients in the diagnostic surgery group and the 65 patients with an [18F]FDG-positive index nodule in the [18F]FDG-PET/CT-driven group were advised to proceed to the scheduled diagnostic surgery. One patient in the diagnostic surgery group and two patients in the [18F]FDG-PET/CT-driven group, all with [18F]FDG-positive nodules, waived surgery. To date, after 28-42 months of follow-up and repeated ultrasound exams, none of these nodules have changed; they are considered benign (false-positive). In total, 106 of 132 (80.3%) patients underwent diagnostic surgery during study follow-up (Table 4). Blinded central review of the histopathology was discordant with the local diagnosis and changed the final classification in six of 132 cases (6%) (Table 5). Thirty-four (26%) nodules had a histopathological diagnosis that justified surgery, including 25 malignancies, five NIFTP, three FTUMP, and one paraganglioma. Seventy-two (55%) nodules had benign histopathology. In addition
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