Cohort Trial on Perioperative Localization Techniques of Parathyroid Adenomas

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cohort Trial on Perioperative Localization Techniques of Parathyroid Adenomas

Conditions
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Primary Hyperparathyroidism

Intervention / Treatment
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* Diagnostic Test: 3D-VNE (virtual neck exploration)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with biochemically confirmed PHPT who are scheduled for elective parathyroidectomy Patient able to receive and understand trial information Patient affiliated with the French social security system Exclusion Criteria: Patient expressing opposition to the use, after anonymization, of medical data for scientific research Pregnant or breast-feeding woman Patient under guardianship or curatorship Patient under the protection of justice

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: 3D-VNE (virtual neck exploration)|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Surgery time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | 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) | 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 | (True positives + True negatives) / number of patients | 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) | 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) | 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) | 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) | 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 | 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) | 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) | 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) | 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) | 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 | 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) | 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) | 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) | 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) | 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 | 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) | 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) | 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) | 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) | 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 | 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) | 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) | 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) | 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) | 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 | 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) | 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) | 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) | 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) | 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 | 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) | 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) | 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) | 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) | Surgery time | 
| Percentage of patients with minimally invasive parathyroidectomy approach | Number of patients with minimally invasive parathyroidectomy/ total number of operated patients | Surgery time | 
| Percentage of patients with classical cervicotomy parathyroidectomy approach | Number of patients with classical cervicotomy parathyroidectomy/ total number of operated patients | 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 | Surgery time | 
| Hyperparathyroidism recurrence rate | Number of patients with recurrent / total number of operated patients | 1 year postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary hyperparathyroidism, parathyroidectomy, 3D reconstruction, Virtual neck exploration