| ObjectiveTo explore the value of Simplified Thyroid Imaging Reporting and Data System for diagnosis of thyroid nodules.Furthermore,the PTN and Tg concentration were measured by ELISA in the in vivo and ex vivo thyroid nodular fine needle aspiration biopsy(FNA)puncture samples,and discuss the value of PTN detection in the differential diagnosis of benign and malignant thyroid nodules.Methods1.The methods of investigating the value of sTI-RADS in the diagnosis and treatment of thyroid nodulesEstablish sTI-RADS by literature review,which is based on four malignant ultrasound features of thyroid nodules.A total of 490 nodules were included in this study.Three sonographers with different years of experience evaluated nodules independently.The rate of malignancy were calculated in each grade.Then,we used the SPSS20.0 software to compare and analyse the data.Inter-observer agreement was calculated using the kappa statistic.Sensitivity,specificity,NPV,PPV,accuracy and Receiver-operating characteristic curve(ROC curve)were used to assess the value of sTI-RADS.2.The methods to discuss the value of PTN detection in the differential diagnosis of benign and malignant thyroid nodules includes these parts:(1)Sample collection: 1)in vivo FNA group: select 149 nodules which underwent FNA percutaneously,ultrasound classification(according to Simplified Thyroid Imaging Reporting and Data System)were 3-4 class/level,excluding 56 nodules which didn’t fit the enrollment criteria.A total of 93 nodules were admitted.2)ex vivo FNA group: select 77 nodules which underwent surgery in General surgery department of a third-grade class-A hospital in Tianjin,excluding 12 nodules which didn’t fit the enrollment criteria,a total of 65 cases were admitted.(2)Puncture method: 1)in vivo FNA group: with the real-time guiding of ultrasound(Esaote Classic C,Italian),no negative pressure by using 25G puncture needle(HAKKO,Japan),3-6 needle tracks,the total number of puncture was 10-20times.0.5 ml PBS containing 1%BSA was used as the rinse solution.Immediately after the sample was taken,it was stored in the liquid nitrogen at-80℃.2)ex vivo FNA group:after the surgery tissue sample taken ex vivo,cut open lesions and normal tissue around,using 25G puncture needle(HAKKO,Japan)under straight look,3-6 needle tracks,the total number of puncture was 10-20 times.The sample was pushed into 0.5ml buffer and washed repeatedly,then stored into-80℃liquid nitrogen.(3)Testing procedure: The concentration of PTN in the puncture sample was tested by using ELISA,while the level of thyroglobulin in the eluate was tested by using immunofluorescence.The expression of BRAFV600 E gene was detected by real-time PCR.On the same day the patient’s thyroid function(T3,T4,TSH)and thyroid antibody(TPOAb,TgAb,TRAb)of peripheral blood were tested.(4)Statistical analysis: The correlation between PTN and Tg in benign and malignant nodules was analyzed by SPSS20.0 statistical software.The expression difference of PTN,Tg and PTN/Tg between benign and malignant nodules was analyzed.Whether there was relationship between PTN/Tg and BRAFV600 E gene mutation,lymph node metastasis and nodule diameter in malignant nodules was also analyzed.Results1.The results about the value of Simplified Thyroid Imaging Reporting and Data System for diagnosis of thyroid nodules in below:The average malignancy rate of each grade from 1 to 5 classes of sTI-RADS are0%、4.09%、25.44%、64.86%、100%.The kappa values between sonographers with different experience were 0.63、0.69、0.63.Sensitivity,specificity,PPV,NPV,and accuracy were 94.11% 、 78.35% 、 53.33% 、 98.06% 、 81.63% for experienced sonographer.The area under the ROC curve were 0.918、0.877、0.905 respectively.2.The results of discussing the value of PTN detection in the differential diagnosis of benign and malignant thyroid nodules includes these parts:(1)The characteristics of samples: among the 93 nodules recruited in vivo FNA group,51 nodules were benign,42 nodules were malignant.Among the 65 nodules recruited in ex vivo FNA group,25 nodules were benign,40 nodules were malignant.All of the surgical malignant nodules were papillary thyroid carcinoma,including 30 nodules of typical thyroid papillary carcinoma,8 nodules of follicular subtype,1nodule of diffuse sclerosing variant type,1 nodule of columnar cell subtype.There were 33 nodules(33/40)of surgical ex vivo malignant nodules had results of Braf V600 E mutation test.BRAF V600 E mutation existed in 23 nodules(23/33).18 among 40 surgical ex vivo malignant nodules accompanied with central or cervical lymph node metastasis(18/40).(2)Association of PTN and Tg concentrations in benign and malignant nodules:there is correlation between PTN and Tg concentrations of in vivo and ex vivo FNA nodules(R2= 0.1424,P =0.0063;R2 = 0.1600,P =0.0476)(3)Comparision of PTN,Tg and PTN/Tg ratio in benign and malignant nodules:PTN concentrations and PTN/Tg ratio was higher in malignant nodules than benign,either in vivo or ex vivo FNA nodules.(PTN:506.43±29.63 vs 215.67±15.86 pg/ml,P<0.0001;481.81±39.24 vs 323.08±33.36 pg/ml,P=0.0128 PTN/Tg:23.5±4.7 vs4.7±1.1 pg/ug,P<0.0001;4.1±0.4 vs 2.2±0.3 pg/ug,P<0.0001)。Tg concentration was higher in benign nodules than malignant,either in vivo or ex vivo FNA nodules.(165.60±20.35 vs 77.75±13.78 ug/ml,P=0.0027;196.82±27.51 vs 139.86±12.17pg/ml,P=0.0477).PTN/Tg ratio was higher in malignant nodules than benign,either in vivo or ex vivo FNA nodules.(23.5±4.7 vs 4.7±1.1 pg/ug,P<0.0001;4.1±0.4 vs2.2±0.3 pg/ug,P<0.0001)(4)Comparision of PTN expression and PTN/Tg ratio in samples of in and ex vivo FNA: 6 typical thyroid papillary carcinoma nodules tested PTN and Tg concentrations both in and ex vivo.There was no statistic significance in PTN,Tg,PTN / Tg both in and ex vivo.(520.68±36.10 vs 460.18±103.83 pg/ml,P=0.5634;87.45±53.86 vs 165.67±45.36 ug/ml,P=0.0803;40.8±28.0 vs 3.5±1.3 pg/ug,P=0.2583)(5)Association among PTN/Tg,lymph node metastasis,BRAF V600 E mutation,size of nodules in ex vivo FNA group:there’s no significant correlation among those factors above.(r=0.061,P=0.710;r=-0.296,P=0.094;r=0.292,P=0.067)Conclusion1.The sTI-RADS is a simplified and repeatable imaging reporting and data system,which can be used as a communication tool of thyroid nodules between different physicians.2.Our study compared the levels of PTN and PTN / Tg in benign and malignant thyroid nodules which did FNA both in and ex vivo,we found that the levels of PTN and PTN / Tg in malignant nodules were higher than those in benign group.There was no statistic significance in PTN and PTN / Tg levels of malignant nodules between the in and ex vivo FNA group,indicating that PTN and PTN / Tg levels were expected to be a new method for the differential diagnosis of benign and malignant thyroid nodules by percutaneous FNA. |