Primary HyperparathyroidismParaCatINCT04013100
Cohort Trial on Perioperative Localization Techniques of Parathyroid Adenomas
An observational study of Primary Hyperparathyroidism, run by IHU Strasbourg.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Hyperparathyroidism
- What is being tested?
- 3D-VNE (virtual neck exploration)
- How many people
- 235 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 31 Dec 2018
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients, male or female, with a confirmed biological diagnosis of primary hyperparathyroidism and for whom preoperative or intraoperative imaging is planned
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
- Primary Hyperparathyroidism
- Being tested
- 3D-VNE (virtual neck exploration)
- Keywords
- primary hyperparathyroidism, parathyroidectomy, 3D reconstruction, Virtual neck exploration
- Medical subject headings
- Hyperparathyroidism, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-VNE (virtual neck exploration)Diagnostic test
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 is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Surgery time
Secondary outcomes (43)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Surgery time
Percentage of patients with minimally invasive parathyroidectomy approach
Number of patients with minimally invasive parathyroidectomy/ total number of operated patients
Measured: Surgery time
Percentage of patients with classical cervicotomy parathyroidectomy approach
Number of patients with classical cervicotomy parathyroidectomy/ total number of operated patients
Measured: 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
Measured: Surgery time
Hyperparathyroidism recurrence rate
Number of patients with recurrent / total number of operated patients
Measured: 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start1 Jan 2014
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Why it stopped: Departure of the main investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Primary HyperparathyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 235 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- IHU Strasbourg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mihaela IGNAT, MD, Principal investigator, Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013100
- Sponsor's protocol ID
- 18-006
- Acronym
- ParaCatI
- Status last verified
- Jan 2024
- First submitted
- 5 Jul 2019
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 28620896D'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 23558758D'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 22970967D'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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Trial on Perioperative Localization Techniques of Parathyroid Adenomas
- ClinicalTrials.gov ID
- NCT04013100
- Acronym / sponsor ID
- ParaCatI / 18-006
- Conditions
- Primary Hyperparathyroidism
- Keywords
- primary hyperparathyroidism, parathyroidectomy, 3D reconstruction, Virtual neck exploration
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Departure of the main investigator
- Enrolment
- 235 participants (actual)
- Lead sponsor
- IHU StrasbourgUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 9 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients, male or female, with a confirmed biological diagnosis of primary hyperparathyroidism and for whom preoperative or intraoperative imaging is planned
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | – |
Primary outcome
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
43 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
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
Time frame: Surgery time
Positive predictive value of 3D-VNE (virtual neck exploration) in indicating the localization of the parathyroid adenoma(s)
Time frame: Surgery time
Negative predictive value of 3D-VNE (virtual neck exploration) in indicating the localization of the parathyroid adenoma(s)
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
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
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
Time frame: Surgery time
Positive predictive value of Computed Tomography in indicating the localization of the parathyroid adenoma(s)
Time frame: Surgery time
Negative predictive value of Computed Tomography in indicating the localization of the parathyroid adenoma(s)
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
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
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
Time frame: Surgery time
Positive predictive value of 99mTc SestaMIBI Scan in indicating the localization of the parathyroid adenoma(s)
Time frame: Surgery time
Negative predictive value of 99mTc SestaMIBI Scan in indicating the localization of the parathyroid adenoma(s)
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
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
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
Time frame: Surgery time
Positive predictive value of cervical ultrasound in indicating the localization of the parathyroid adenoma(s)
Time frame: Surgery time
Negative predictive value of cervical ultrasound in indicating the localization of the parathyroid adenoma(s)
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
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
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
Time frame: Surgery time
Positive predictive value of cervical MRI in indicating the localization of the parathyroid adenoma(s)
Time frame: Surgery time
Negative predictive value of cervical MRI in indicating the localization of the parathyroid adenoma(s)
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
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
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
Time frame: 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
Negative predictive value of 18F-Fluorocholine Positron Emission Tomography-Computed Tomography in indicating the localization of the parathyroid adenoma(s)
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
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
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
Time frame: Surgery time
Positive predictive value of parathyroid autofluorescence detection in indicating the localization of the parathyroid adenoma(s)
Time frame: Surgery time
Negative predictive value of parathyroid autofluorescence detection in indicating the localization of the parathyroid adenoma(s)
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
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
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
Time frame: Surgery time
Positive predictive value of Intraoperative probe-based confocal endomicroscopy in indicating the localization of the parathyroid adenoma(s)
Time frame: Surgery time
Negative predictive value of Intraoperative probe-based confocal endomicroscopy in indicating the localization of the parathyroid adenoma(s)
Time frame: Surgery time
Percentage of patients with minimally invasive parathyroidectomy approach
Time frame: Surgery time
Results and safety
The study was stopped early (reason given: Departure of the main investigator). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Background: PubMed 28620896Sessa 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.
- Background: PubMed 23558758D'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.
- Background: PubMed 22970967D'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.
- Background: PubMed 23682370D'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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mihaela IGNAT, MD principal investigator
Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Hyperparathyroidism, run by IHU Strasbourg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Departure of the main investigator). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04013100, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.