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Departure of the main investigator
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D-VNE (virtual neck exploration) | Diagnostic Test | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients, male or female, with a confirmed biological diagnosis of primary hyperparathyroidism and for whom preoperative or intraoperative imaging is planned
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| Name | Affiliation | Role |
|---|---|---|
| Mihaela IGNAT, MD | Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28620896 | Background | Sessa L, Lombardi CP, De Crea C, Raffaelli M, Bellantone R. Video-assisted endocrine neck surgery: state of the art. Updates Surg. 2017 Jun;69(2):199-204. doi: 10.1007/s13304-017-0467-3. Epub 2017 Jun 15. | |
| 23558758 | Background | D'Agostino J, Diana M, Vix M, Nicolau S, Soler L, Bourhala K, Hassler S, Wu HS, Marescaux J. Three-dimensional metabolic and radiologic gathered evaluation using VR-RENDER fusion: a novel tool to enhance accuracy in the localization of parathyroid adenomas. World J Surg. 2013 Jul;37(7):1618-25. doi: 10.1007/s00268-013-2021-x. |
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| ID | Term |
|---|---|
| D049950 | Hyperparathyroidism, Primary |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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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 |
| 22970967 | Background | D'Agostino J, Diana M, Vix M, Soler L, Marescaux J. Three-dimensional virtual neck exploration before parathyroidectomy. N Engl J Med. 2012 Sep 13;367(11):1072-3. doi: 10.1056/NEJMc1201488. No abstract available. |
| 23682370 | Background | D'Agostino J, Wall J, Soler L, Vix M, Duh QY, Marescaux J. Virtual neck exploration for parathyroid adenomas: a first step toward minimally invasive image-guided surgery. JAMA Surg. 2013 Mar;148(3):232-8; discussion 238. doi: 10.1001/jamasurg.2013.739. |