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

• ClinicalTrials.gov Identifier: NCT04013100
• Recruitment Status: Terminated
• First Posted: July 9, 2019
• Last Update Posted: January 9, 2024
• Sponsor: IHU Strasbourg
• Information provided by (Responsible Party): IHU Strasbourg

Study Description

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.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 235 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 1 Year
• Official Title: Cohort Trial on Perioperative Localization Techniques of Parathyroid Adenomas
• Actual Study Start Date: January 1, 2014
• Actual Primary Completion Date: December 31, 2018
• Actual Study Completion Date: December 31, 2018

Groups and Cohorts

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Sponsors and Collaborators

IHU Strasbourg

Investigators

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

More Information

Publications:

Sessa L, Lombardi CP, De Crea C, Raffaelli M, Bellantone R. Video-assisted endocrine neck surgery: state of the art. Updates Surg. 2017 Jun;69(2):199-204. doi: 10.1007/s13304-017-0467-3. Epub 2017 Jun 15.

D'Agostino J, Diana M, Vix M, Nicolau S, Soler L, Bourhala K, Hassler S, Wu HS, Marescaux J. Three-dimensional metabolic and radiologic gathered evaluation using VR-RENDER fusion: a novel tool to enhance accuracy in the localization of parathyroid adenomas. World J Surg. 2013 Jul;37(7):1618-25. doi: 10.1007/s00268-013-2021-x.

D'Agostino J, Diana M, Vix M, Soler L, Marescaux J. Three-dimensional virtual neck exploration before parathyroidectomy. N Engl J Med. 2012 Sep 13;367(11):1072-3. doi: 10.1056/NEJMc1201488. No abstract available.

D'Agostino J, Wall J, Soler L, Vix M, Duh QY, Marescaux J. Virtual neck exploration for parathyroid adenomas: a first step toward minimally invasive image-guided surgery. JAMA Surg. 2013 Mar;148(3):232-8; discussion 238. doi: 10.1001/jamasurg.2013.739.

• Responsible Party: IHU Strasbourg
• ClinicalTrials.gov Identifier: NCT04013100
• Other Study ID Numbers: 18-006
• First Posted: July 9, 2019
• Last Update Posted: January 9, 2024
• Last Verified: January 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

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