TerminatedNCT04013100ParaCatIUpdated Jan 9, 2024

Cohort Trial on Perioperative Localization Techniques of Parathyroid Adenomas

An observational study in Primary Hyperparathyroidism, sponsored by IHU Strasbourg. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-09.

Sponsored by IHU Strasbourg · Observational

Why this study was terminated

Departure of the main investigator

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 235
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Primary Hyperparathyroidism

Browse trials for

Hyperparathyroidism, Primary 104

Keywords

primary hyperparathyroidism
parathyroidectomy
3D reconstruction
Virtual neck exploration

In context

Hyperparathyroidism, Primary

104 studies on the registry are indexed under Hyperparathyroidism, Primary; 23 are open to participants now.

This study's enrollment of 235 is above the median of 130 across 40 observational studies indexed under Hyperparathyroidism, Primary.

Browse Hyperparathyroidism, Primary studies →

Lead sponsor

IHU Strasbourg is the lead sponsor of 44 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients with biochemically confirmed PHPT who are scheduled for elective parathyroidectomy
Patient able to receive and understand trial information
Patient affiliated with the French social security system

Exclusion criteria

Exclusion Criteria:

Patient expressing opposition to the use, after anonymization, of medical data for scientific research
Pregnant or breast-feeding woman
Patient under guardianship or curatorship
Patient under the protection of justice

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 235 participants (actual)
Target follow-up: 1 Year
Patient registry: Yes

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.

What researchers measure

Primary outcomes

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
Time frame: Surgery time

Secondary outcomes

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

Study locations

No study locations are listed for this record.

References and documents

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. PubMed 28620896 ↗
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. PubMed 23558758 ↗
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. PubMed 22970967 ↗
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. PubMed 23682370 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04013100
Lead sponsor: IHU Strasbourg
Responsible party: Sponsor
First posted: Jul 9, 2019
Start date: Jan 1, 2014
Primary completion: Dec 31, 2018
Completion: Dec 31, 2018
Last update: Jan 9, 2024

Study contacts

Mihaela IGNAT, MD

principal investigator · Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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