Cohort Trial on Perioperative Localization Techniques of Parathyroid Adenomas

Primary Hyperparathyroidism Clinical Trial

— ParaCatI  

Official title:

Cohort Trial on Perioperative Localization Techniques of Parathyroid Adenomas

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04013100
• Other study ID #: 18-006
• Status: Terminated
• Start date: January 1, 2014
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2024
• Source: IHU Strasbourg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 235
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Parathyroid Neoplasms
• Primary Hyperparathyroidism

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IHU Strasbourg

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Percentage of patients with minimally invasive parathyroidectomy approach	Number of patients with minimally invasive parathyroidectomy/ total number of operated patients	Surgery time
Secondary	Percentage of patients with classical cervicotomy parathyroidectomy approach	Number of patients with classical cervicotomy parathyroidectomy/ total number of operated patients	Surgery time
Secondary	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
Secondary	Hyperparathyroidism recurrence rate	Number of patients with recurrent / total number of operated patients	1 year postoperatively