Cohort Trial on Perioperative Localization Techniques of Parathyroid Adenomas

Terminated

• Conditions: Primary Hyperparathyroidism

• Registration Number: NCT04013100
• Lead Sponsor: IHU Strasbourg

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.

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Study First Submitted: 2019-07-05
• Study First Submitted QC: 2019-07-05
• Study First Posted: 2019-07-09
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-05
• Last Update Posted: 2024-01-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 235

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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)
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
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)
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 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
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)
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
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)
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)
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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 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)
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)
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)
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
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)
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)
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)
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)
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)
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)
Hyperparathyroidism recurrence rate	1 year postoperatively	Number of patients with recurrent / total number of operated patients
Percentage of patients with classical cervicotomy parathyroidectomy approach	Surgery time	Number of patients with classical cervicotomy 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
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)
Percentage of patients with minimally invasive parathyroidectomy approach	Surgery time	Number of patients with minimally invasive parathyroidectomy/ total number of operated patients