Cohort Trial on Perioperative Localization Techniques of Parathyroid Adenomas (ParaCatI)

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.

Study Overview

• Status: Terminated
• Conditions: Primary Hyperparathyroidism
• Intervention / Treatment: Diagnostic test: 3D-VNE (virtual neck exploration)

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 Type: Observational
• Enrollment (Actual): 235

Contacts and Locations

• Study Contact: Name: Armelle Takeda, PhD; Phone Number: +33(0)390413608; Email: armelle.takeda@ihu-strasbourg.eu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients, male or female, with a confirmed biological diagnosis of primary hyperparathyroidism and for whom preoperative or intraoperative imaging is planned

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: IHU Strasbourg
• Investigators: Principal Investigator: Mihaela IGNAT, MD, Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: July 5, 2019
• First Submitted That Met QC Criteria: July 5, 2019
• First Posted (Actual): July 9, 2019

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: primary hyperparathyroidism; parathyroidectomy; 3D reconstruction; Virtual neck exploration
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Parathyroid Diseases; Head and Neck Neoplasms; Hyperparathyroidism; Hyperparathyroidism, Primary; Adenoma; Parathyroid Neoplasms
• Other Study ID Numbers: 18-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No