Primary Hyperparathyroidism
Conditions
Keywords
primary hyperparathyroidism, parathyroidectomy, 3D reconstruction, Virtual neck exploration
Brief summary
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
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.
Interventions
DIAGNOSTIC_TEST3D-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.
Sponsors
IHU Strasbourg
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with biochemically confirmed PHPT who are scheduled for elective parathyroidectomy 2. Patient able to receive and understand trial information 3. Patient affiliated with the French social security system
Exclusion criteria
1. Patient expressing opposition to the use, after anonymization, of medical data for scientific research 2. Pregnant or breast-feeding woman 3. Patient under guardianship or curatorship 4. Patient under the protection of justice
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Surgery time | (true positives + true negatives) / number of patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Surgery time | Sensitivity = True Positives / (True Positives + False Negatives) |
| 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 | Surgery time | Specificity = True Negatives / (True Negatives + False Positives) |
| Positive predictive value of 3D-VNE (virtual neck exploration) in indicating the localization of the parathyroid adenoma(s) | Surgery time | Positive predictive value = True Positives / (True Positives + False Positives) |
| Negative predictive value of 3D-VNE (virtual neck exploration) in indicating the localization of the parathyroid adenoma(s) | Surgery time | Negative predictive value = True Negatives / (True Negatives + False Negatives) |
| 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 | Surgery time | (True positives + True negatives) / number of patients |
| 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 | Surgery time | Sensitivity = True Positives / (True Positives + False Negatives) |
| 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 | Surgery time | Specificity = True Negatives / (True Negatives + False Positives) |
| Positive predictive value of Computed Tomography in indicating the localization of the parathyroid adenoma(s) | Surgery time | Positive predictive value = True Positives / (True Positives + False Positives) |
| Negative predictive value of Computed Tomography in indicating the localization of the parathyroid adenoma(s) | Surgery time | Negative predictive value = True Negatives / (True Negatives + False Negatives) |
| 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 | Surgery time | (True positives + True negatives) / number of patients |
| 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 | Surgery time | Sensitivity = True Positives / (True Positives + False Negatives) |
| 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 | Surgery time | Specificity = True Negatives / (True Negatives + False Positives) |
| Positive predictive value of 99mTc SestaMIBI Scan in indicating the localization of the parathyroid adenoma(s) | Surgery time | Positive predictive value = True Positives / (True Positives + False Positives) |
| Negative predictive value of 99mTc SestaMIBI Scan in indicating the localization of the parathyroid adenoma(s) | Surgery time | Negative predictive value = True Negatives / (True Negatives + False Negatives) |
| 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 | Surgery time | (True positives + True negatives) / number of patients |
| 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 | Surgery time | Sensitivity = True Positives / (True Positives + False Negatives) |
| 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 | Surgery time | Specificity = True Negatives / (True Negatives + False Positives) |
| Positive predictive value of cervical ultrasound in indicating the localization of the parathyroid adenoma(s) | Surgery time | Positive predictive value = True Positives / (True Positives + False Positives) |
| Negative predictive value of cervical ultrasound in indicating the localization of the parathyroid adenoma(s) | Surgery time | Negative predictive value = True Negatives / (True Negatives + False Negatives) |
| 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 | Surgery time | (True positives + True negatives) / number of patients |
| 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 | Surgery time | Sensitivity = True Positives / (True Positives + False Negatives) |
| 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 | Surgery time | Specificity = True Negatives / (True Negatives + False Positives) |
| Positive predictive value of cervical MRI in indicating the localization of the parathyroid adenoma(s) | Surgery time | Positive predictive value = True Positives / (True Positives + False Positives) |
| Negative predictive value of cervical MRI in indicating the localization of the parathyroid adenoma(s) | Surgery time | Negative predictive value = True Negatives / (True Negatives + False Negatives) |
| 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 | Surgery time | (True positives + True negatives) / number of patients |
| 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 | Surgery time | Sensitivity = True Positives / (True Positives + False Negatives) |
| 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 | Surgery time | Specificity = True Negatives / (True Negatives + False Positives) |
| Positive predictive value of 18F-Fluorocholine Positron Emission Tomography-Computed Tomography in indicating the localization of the parathyroid adenoma(s) | Surgery time | Positive predictive value = True Positives / (True Positives + False Positives) |
| Negative predictive value of 18F-Fluorocholine Positron Emission Tomography-Computed Tomography in indicating the localization of the parathyroid adenoma(s) | Surgery time | Negative predictive value = True Negatives / (True Negatives + False Negatives) |
| 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 | Surgery time | (True positives + True negatives) / number of patients |
| 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 | Surgery time | Sensitivity = True Positives / (True Positives + False Negatives) |
| 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 | Surgery time | Specificity = True Negatives / (True Negatives + False Positives) |
| Positive predictive value of parathyroid autofluorescence detection in indicating the localization of the parathyroid adenoma(s) | Surgery time | Positive predictive value = True Positives / (True Positives + False Positives) |
| Negative predictive value of parathyroid autofluorescence detection in indicating the localization of the parathyroid adenoma(s) | Surgery time | Negative predictive value = True Negatives / (True Negatives + False Negatives) |
| 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 | Surgery time | (True positives + True negatives) / number of patients |
| 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 | Surgery time | Sensitivity = True Positives / (True Positives + False Negatives) |
| 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 | Surgery time | Specificity = True Negatives / (True Negatives + False Positives) |
| Percentage of patients with classical cervicotomy parathyroidectomy approach | Surgery time | Number of patients with classical cervicotomy parathyroidectomy/ total number of operated patients |
| Negative predictive value of Intraoperative probe-based confocal endomicroscopy in indicating the localization of the parathyroid adenoma(s) | Surgery time | Negative predictive value = True Negatives / (True Negatives + False Negatives) |
| Percentage of patients with minimally invasive parathyroidectomy approach | Surgery time | Number of patients with minimally invasive parathyroidectomy/ total number of operated patients |
| Percentage of patients necessitating conversion from minimally invasive parathyroidectomy approach to classical cervicotomy | Surgery time | Number of patients necessitating conversion from minimally invasive parathyroidectomy approach to classical cervicotomy / total number of operated patients |
| Hyperparathyroidism recurrence rate | 1 year postoperatively | Number of patients with recurrent / total number of operated patients |
| Positive predictive value of Intraoperative probe-based confocal endomicroscopy in indicating the localization of the parathyroid adenoma(s) | Surgery time | Positive predictive value = True Positives / (True Positives + False Positives) |
Outcome results
None listed