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

January 5, 2024 updated by: IHU Strasbourg
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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
235

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: Surgery time
(true positives + true negatives) / number of patients
Surgery time

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: Surgery time
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
Time Frame: Surgery time
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)
Time Frame: Surgery time
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)
Time Frame: Surgery time
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
Time Frame: Surgery time
(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
Time Frame: Surgery time
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
Time Frame: Surgery time
Specificity = True Negatives / (True Negatives + False Positives)
Surgery time
Positive predictive value of Computed Tomography in indicating the localization of the parathyroid adenoma(s)
Time Frame: Surgery time
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)
Time Frame: Surgery time
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
Time Frame: Surgery time
(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
Time Frame: Surgery time
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
Time Frame: Surgery time
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)
Time Frame: Surgery time
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)
Time Frame: Surgery time
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
Time Frame: Surgery time
(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
Time Frame: Surgery time
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
Time Frame: Surgery time
Specificity = True Negatives / (True Negatives + False Positives)
Surgery time
Positive predictive value of cervical ultrasound in indicating the localization of the parathyroid adenoma(s)
Time Frame: Surgery time
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)
Time Frame: Surgery time
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
Time Frame: Surgery time
(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
Time Frame: Surgery time
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
Time Frame: Surgery time
Specificity = True Negatives / (True Negatives + False Positives)
Surgery time
Positive predictive value of cervical MRI in indicating the localization of the parathyroid adenoma(s)
Time Frame: Surgery time
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)
Time Frame: Surgery time
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
Time Frame: Surgery time
(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
Time Frame: Surgery time
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
Time Frame: Surgery time
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)
Time Frame: Surgery time
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)
Time Frame: Surgery time
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
Time Frame: Surgery time
(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
Time Frame: Surgery time
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
Time Frame: Surgery time
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)
Time Frame: Surgery time
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)
Time Frame: Surgery time
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
Time Frame: Surgery time
(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
Time Frame: Surgery time
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
Time Frame: Surgery time
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)
Time Frame: Surgery time
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)
Time Frame: Surgery time
Negative predictive value = True Negatives / (True Negatives + False Negatives)
Surgery time
Percentage of patients with minimally invasive parathyroidectomy approach
Time Frame: Surgery time
Number of patients with minimally invasive parathyroidectomy/ total number of operated patients
Surgery time
Percentage of patients with classical cervicotomy parathyroidectomy approach
Time Frame: Surgery time
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
Time Frame: Surgery time
Number of patients necessitating conversion from minimally invasive parathyroidectomy approach to classical cervicotomy / total number of operated patients
Surgery time
Hyperparathyroidism recurrence rate
Time Frame: 1 year postoperatively
Number of patients with recurrent / total number of operated patients
1 year postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IHU Strasbourg

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mihaela IGNAT, MD, Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Hyperparathyroidism

Clinical Trials on 3D-VNE (virtual neck exploration)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings