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

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ClinicalTrials.gov Identifier: NCT04013100
Recruitment Status : Not yet recruiting
First Posted : July 9, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
IHU Strasbourg

Brief Summary:
A prospective database of consecutive patients with hyperparathyroidism subject to surgery is created. Preoperative workup and operative findings are recorded in this registry to allow comprehensive analysis.

Condition or disease Intervention/treatment
Primary Hyperparathyroidism 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Cohort Trial on Perioperative Localization Techniques of Parathyroid Adenomas
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : December 2029
Estimated Study Completion Date : December 2029



Intervention Details:
  • Diagnostic Test: 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.


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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

  16. 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)

  17. 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)

  18. 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)

  19. 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)

  20. 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

  21. 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)

  22. 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)

  23. 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)

  24. 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)

  25. 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

  26. 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)

  27. 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)

  28. 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)

  29. 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)

  30. 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

  31. 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)

  32. 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)

  33. 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)

  34. 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)

  35. 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

  36. 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)

  37. 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)

  38. 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)

  39. 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)

  40. Percentage of patients with minimally invasive parathyroidectomy approach [ Time Frame: Surgery time ]
    Number of patients with minimally invasive parathyroidectomy/ total number of operated patients

  41. Percentage of patients with classical cervicotomy parathyroidectomy approach [ Time Frame: Surgery time ]
    Number of patients with classical cervicotomy parathyroidectomy/ total number of operated patients

  42. 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

  43. Hyperparathyroidism recurrence rate [ Time Frame: 1 year postoperatively ]
    Number of patients with recurrent / total number of operated patients



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04013100


Contacts
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Contact: Armelle Takeda, PhD +33(0)390413608 armelle.takeda@ihu-strasbourg.eu

Sponsors and Collaborators
IHU Strasbourg
Investigators
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Principal Investigator: Mihaela IGNAT, MD Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg
Publications:
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Responsible Party: IHU Strasbourg
ClinicalTrials.gov Identifier: NCT04013100    
Other Study ID Numbers: 18-006
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by IHU Strasbourg:
primary hyperparathyroidism
parathyroidectomy
3D reconstruction
Virtual neck exploration
Additional relevant MeSH terms:
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Adenoma
Parathyroid Neoplasms
Hyperparathyroidism
Hyperparathyroidism, Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Parathyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms