A prospective database of consecutive patients with hyperparathyroidism subject to surgery is created. Preoperative workup and operative findings are recorded in this registry to allow comprehensive analysis.
This is a non-interventional, prospective, monocentric, non-randomized trial. All patients with biochemically confirmed Primary Hyperparathyroidism (PHPT) who are scheduled for elective parathyroidectomy in the Endocrine and Digestive Surgery Unit of the University Hospital of Strasbourg are considered. Data concerning the age, the operative date, the results of the pre-operative biological work-up (plasma calcium, phosphor, parathyroid hormone (PTH) level, vitamin D), the results of pre-operative imaging (CT (computerized tomography) scan, 99mTc SestaMIBI Scan, 3D-Vitual Neck Exploration (VNE)), the operative data (the surgical approach, the localization and the dimensions of the adenoma (s), the necessity to convert to classical approach and its reason, the values of the intra operative PTH), the pathology results, the biological work-up at follow-up (plasma calcium, phosphor, PTH, vitamin D) are prospectively recorded in the database.
Study Type
OBSERVATIONAL
Enrollment
235
The 3D-VNE model is obtained with VP Planning software (Visible Patient, Strasbourg, France), using DICOM (Digital Imaging and Communications in Medicine) images of contrasted Computed Tomography scan of the neck in operative positioning.
Accuracy of 3D-VNE (virtual neck exploration) in indicating the localization of the parathyroid adenoma(s) assessed by the number of patients with confirmed results divided by the total number of patients who underwent a 3D-VNE
(true positives + true negatives) / number of patients
Time frame: Surgery time
Sensitivity of 3D-VNE (virtual neck exploration) in indicating the localization of the parathyroid adenoma(s) assessed by the ratio of patients who underwent a 3D-VNE with positive confirmed results
Sensitivity = True Positives / (True Positives + False Negatives)
Time frame: Surgery time
Specificity of 3D-VNE (virtual neck exploration) in indicating the localization of the parathyroid adenoma(s) assessed by the ratio of patients who underwent a 3D-VNE with negative confirmed results
Specificity = True Negatives / (True Negatives + False Positives)
Time frame: Surgery time
Positive predictive value of 3D-VNE (virtual neck exploration) in indicating the localization of the parathyroid adenoma(s)
Positive predictive value = True Positives / (True Positives + False Positives)
Time frame: Surgery time
Negative predictive value of 3D-VNE (virtual neck exploration) in indicating the localization of the parathyroid adenoma(s)
Negative predictive value = True Negatives / (True Negatives + False Negatives)
Time frame: Surgery time
Accuracy of Computed Tomography in indicating the localization of the parathyroid adenoma(s) assessed by the number of patients with confirmed results divided by the total number of patients who underwent a Computed Tomography
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(True positives + True negatives) / number of patients
Time frame: Surgery time
Sensitivity of Computed Tomography in indicating the localization of the parathyroid adenoma(s) assessed by the ratio of patients who underwent a Computed Tomography with positive confirmed results
Sensitivity = True Positives / (True Positives + False Negatives)
Time frame: Surgery time
Specificity of Computed Tomography in indicating the localization of the parathyroid adenoma(s) assessed by the ratio of patients who underwent a Computed Tomography with negative confirmed results
Specificity = True Negatives / (True Negatives + False Positives)
Time frame: Surgery time
Positive predictive value of Computed Tomography in indicating the localization of the parathyroid adenoma(s)
Positive predictive value = True Positives / (True Positives + False Positives)
Time frame: Surgery time
Negative predictive value of Computed Tomography in indicating the localization of the parathyroid adenoma(s)
Negative predictive value = True Negatives / (True Negatives + False Negatives)
Time frame: Surgery time
Accuracy of 99mTc SestaMIBI Scan in indicating the localization of the parathyroid adenoma(s) assessed by the number of patients with confirmed results divided by the total number of patients who underwent a 99mTc SestaMIBI Scan
(True positives + True negatives) / number of patients
Time frame: Surgery time
Sensitivity of 99mTc SestaMIBI Scan in indicating the localization of the parathyroid adenoma(s) assessed by the ratio of patients who underwent a 99mTc SestaMIBI Scan with positive confirmed results
Sensitivity = True Positives / (True Positives + False Negatives)
Time frame: Surgery time
Specificity of 99mTc SestaMIBI Scan in indicating the localization of the parathyroid adenoma(s) assessed by the ratio of patients who underwent a 99mTc SestaMIBI Scan with negative confirmed results
Specificity = True Negatives / (True Negatives + False Positives)
Time frame: Surgery time
Positive predictive value of 99mTc SestaMIBI Scan in indicating the localization of the parathyroid adenoma(s)
Positive predictive value = True Positives / (True Positives + False Positives)
Time frame: Surgery time
Negative predictive value of 99mTc SestaMIBI Scan in indicating the localization of the parathyroid adenoma(s)
Negative predictive value = True Negatives / (True Negatives + False Negatives)
Time frame: Surgery time
Accuracy of cervical ultrasound in indicating the localization of the parathyroid adenoma(s) assessed by the number of patients with confirmed results divided by the total number of patients who underwent a cervical ultrasound
(True positives + True negatives) / number of patients
Time frame: Surgery time
Sensitivity of cervical ultrasound in indicating the localization of the parathyroid adenoma(s) assessed by the ratio of patients who underwent a cervical ultrasound with positive confirmed results
Sensitivity = True Positives / (True Positives + False Negatives)
Time frame: Surgery time
Specificity of cervical ultrasound in indicating the localization of the parathyroid adenoma(s) assessed by the ratio of patients who underwent a cervical ultrasound with negative confirmed results
Specificity = True Negatives / (True Negatives + False Positives)
Time frame: Surgery time
Positive predictive value of cervical ultrasound in indicating the localization of the parathyroid adenoma(s)
Positive predictive value = True Positives / (True Positives + False Positives)
Time frame: Surgery time
Negative predictive value of cervical ultrasound in indicating the localization of the parathyroid adenoma(s)
Negative predictive value = True Negatives / (True Negatives + False Negatives)
Time frame: Surgery time
Accuracy of cervical MRI in indicating the localization of the parathyroid adenoma(s) assessed by the number of patients with confirmed results divided by the total number of patients who underwent a cervical MRI
(True positives + True negatives) / number of patients
Time frame: Surgery time
Sensitivity of cervical MRI in indicating the localization of the parathyroid adenoma(s) assessed by the ratio of patients who underwent a cervical MRI with positive confirmed results
Sensitivity = True Positives / (True Positives + False Negatives)
Time frame: Surgery time
Specificity of cervical MRI in indicating the localization of the parathyroid adenoma(s) assessed by the ratio of patients who underwent a cervical MRI with negative confirmed results
Specificity = True Negatives / (True Negatives + False Positives)
Time frame: Surgery time
Positive predictive value of cervical MRI in indicating the localization of the parathyroid adenoma(s)
Positive predictive value = True Positives / (True Positives + False Positives)
Time frame: Surgery time
Negative predictive value of cervical MRI in indicating the localization of the parathyroid adenoma(s)
Negative predictive value = True Negatives / (True Negatives + False Negatives)
Time frame: Surgery time
Accuracy of 18F-Fluorocholine Positron Emission Tomography-Computed Tomography in indicating the localization of the parathyroid adenoma(s) assessed by the number of patients with confirmed results divided by the total number of patients
(True positives + True negatives) / number of patients
Time frame: Surgery time
Sensitivity of 18F-Fluorocholine Positron Emission Tomography-Computed Tomography in indicating the localization of the parathyroid adenoma(s) assessed by the ratio of patients who underwent a Computed Tomography with positive confirmed results
Sensitivity = True Positives / (True Positives + False Negatives)
Time frame: Surgery time
Specificity of 18F-Fluorocholine Positron Emission Tomography-Computed Tomography in indicating the localization of the parathyroid adenoma(s) assessed by the ratio of patients who underwent a Computed Tomography with negative confirmed results
Specificity = True Negatives / (True Negatives + False Positives)
Time frame: Surgery time
Positive predictive value of 18F-Fluorocholine Positron Emission Tomography-Computed Tomography in indicating the localization of the parathyroid adenoma(s)
Positive predictive value = True Positives / (True Positives + False Positives)
Time frame: Surgery time
Negative predictive value of 18F-Fluorocholine Positron Emission Tomography-Computed Tomography in indicating the localization of the parathyroid adenoma(s)
Negative predictive value = True Negatives / (True Negatives + False Negatives)
Time frame: Surgery time
Accuracy of parathyroid autofluorescence detection in indicating the localization of the parathyroid adenoma(s) assessed by the number of patients with confirmed results divided by the total number of patients who underwent a parathyroid autofluorescence
(True positives + True negatives) / number of patients
Time frame: Surgery time
Sensitivity of parathyroid autofluorescence detection in indicating the localization of the parathyroid adenoma(s) assessed by the ratio of patients who underwent a parathyroid autofluorescence detection with positive confirmed results
Sensitivity = True Positives / (True Positives + False Negatives)
Time frame: Surgery time
Specificity of parathyroid autofluorescence detection in indicating the localization of the parathyroid adenoma(s) assessed by the ratio of patients who underwent a parathyroid autofluorescence detection with negative confirmed results
Specificity = True Negatives / (True Negatives + False Positives)
Time frame: Surgery time
Positive predictive value of parathyroid autofluorescence detection in indicating the localization of the parathyroid adenoma(s)
Positive predictive value = True Positives / (True Positives + False Positives)
Time frame: Surgery time
Negative predictive value of parathyroid autofluorescence detection in indicating the localization of the parathyroid adenoma(s)
Negative predictive value = True Negatives / (True Negatives + False Negatives)
Time frame: Surgery time
Accuracy of Intraoperative probe-based confocal endomicroscopy in indicating the localization of the parathyroid adenoma(s) assessed by the number of patients with confirmed results divided by the total number of patients
(True positives + True negatives) / number of patients
Time frame: Surgery time
Sensitivity of Intraoperative probe-based confocal endomicroscopy in indicating the localization of the parathyroid adenoma(s) assessed by the ratio of patients with positive confirmed results
Sensitivity = True Positives / (True Positives + False Negatives)
Time frame: Surgery time
Specificity of Intraoperative probe-based confocal endomicroscopy in indicating the localization of the parathyroid adenoma(s) assessed by the ratio of patients with negative confirmed results
Specificity = True Negatives / (True Negatives + False Positives)
Time frame: Surgery time
Positive predictive value of Intraoperative probe-based confocal endomicroscopy in indicating the localization of the parathyroid adenoma(s)
Positive predictive value = True Positives / (True Positives + False Positives)
Time frame: Surgery time
Negative predictive value of Intraoperative probe-based confocal endomicroscopy in indicating the localization of the parathyroid adenoma(s)
Negative predictive value = True Negatives / (True Negatives + False Negatives)
Time frame: Surgery time
Percentage of patients with minimally invasive parathyroidectomy approach
Number of patients with minimally invasive parathyroidectomy/ total number of operated patients
Time frame: Surgery time
Percentage of patients with classical cervicotomy parathyroidectomy approach
Number of patients with classical cervicotomy parathyroidectomy/ total number of operated patients
Time frame: Surgery time
Percentage of patients necessitating conversion from minimally invasive parathyroidectomy approach to classical cervicotomy
Number of patients necessitating conversion from minimally invasive parathyroidectomy approach to classical cervicotomy / total number of operated patients
Time frame: Surgery time
Hyperparathyroidism recurrence rate
Number of patients with recurrent / total number of operated patients
Time frame: 1 year postoperatively