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

Tracking Information

• First Submitted Date: July 5, 2019
• First Posted Date: July 9, 2019
• Last Update Posted Date: January 9, 2024
• Actual Study Start Date: January 1, 2014
• Actual Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 5, 2019)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 5, 2019)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Cohort Trial on Perioperative Localization Techniques of Parathyroid Adenomas
• Official Title: Cohort Trial on Perioperative Localization Techniques of Parathyroid Adenomas
• 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.
• 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: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 1 Year
• Biospecimen: Not Provided
• 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
• Condition: Primary Hyperparathyroidism

Intervention

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.

• Study Groups/Cohorts: Not Provided

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.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: January 5, 2024): 235
• Original Estimated Enrollment (submitted: July 5, 2019): 800
• Actual Study Completion Date: December 31, 2018
• Actual Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT04013100
• Other Study ID Numbers: 18-006
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: IHU Strasbourg
• Original Responsible Party: Same as current
• Current Study Sponsor: IHU Strasbourg
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: IHU Strasbourg
• Verification Date: January 2024