Clinical trial NCT04013100: Cohort Trial on Perioperative Localization Techniques of Parathyroid Adenomas
Official title: Cohort Trial on Perioperative Localization Techniques of Parathyroid Adenomas
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Primary Hyperparathyroidism
Keywords: primary hyperparathyroidism
parathyroidectomy
3D reconstruction
Virtual neck exploration
Lead sponsor: IHU Strasbourg
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
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
timeFrame: Surgery time
Secondary outcomes:
measure: 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
timeFrame: Surgery time
measure: 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
timeFrame: Surgery time
measure: Positive predictive value of 3D-VNE (virtual neck exploration) in indicating the localization of the parathyroid adenoma(s)
timeFrame: Surgery time
measure: Negative predictive value of 3D-VNE (virtual neck exploration) in indicating the localization of the parathyroid adenoma(s)
timeFrame: Surgery time
measure: 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
timeFrame: Surgery time
measure: 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
timeFrame: Surgery time
measure: 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
timeFrame: Surgery time
measure: Positive predictive value of Computed Tomography in indicating the localization of the parathyroid adenoma(s)
timeFrame: Surgery time
measure: Negative predictive value of Computed Tomography in indicating the localization of the parathyroid adenoma(s)
timeFrame: Surgery time
measure: 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
timeFrame: Surgery time
measure: 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
timeFrame: Surgery time
measure: 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
timeFrame: Surgery time
measure: Positive predictive value of 99mTc SestaMIBI Scan in indicating the localization of the parathyroid adenoma(s)
timeFrame: Surgery time
measure: Negative predictive value of 99mTc SestaMIBI Scan in indicating the localization of the parathyroid adenoma(s)
timeFrame: Surgery time
measure: 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
timeFrame: Surgery time
measure: 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
timeFrame: Surgery time
measure: 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
timeFrame: Surgery time
measure: Positive predictive value of cervical ultrasound in indicating the localization of the parathyroid adenoma(s)
timeFrame: Surgery time
measure: Negative predictive value of cervical ultrasound in indicating the localization of the parathyroid adenoma(s)
timeFrame: Surgery time
measure: 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
timeFrame: Surgery time
measure: 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
timeFrame: Surgery time
measure: 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
timeFrame: Surgery time
measure: Positive predictive value of cervical MRI in indicating the localization of the parathyroid adenoma(s)
timeFrame: Surgery time
measure: Negative predictive value of cervical MRI in indicating the localization of the parathyroid adenoma(s)
timeFrame: Surgery time
measure: 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
timeFrame: Surgery time
measure: 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
timeFrame: Surgery time
measure: 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
timeFrame: Surgery time
measure: Positive predictive value of 18F-Fluorocholine Positron Emission Tomography-Computed Tomography in indicating the localization of the parathyroid adenoma(s)
timeFrame: Surgery time
measure: Negative predictive value of 18F-Fluorocholine Positron Emission Tomography-Computed Tomography in indicating the localization of the parathyroid adenoma(s)
timeFrame: Surgery time
measure: 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
timeFrame: Surgery time
measure: 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
timeFrame: Surgery time
measure: 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
timeFrame: Surgery time
measure: Positive predictive value of parathyroid autofluorescence detection in indicating the localization of the parathyroid adenoma(s)
timeFrame: Surgery time
measure: Negative predictive value of parathyroid autofluorescence detection in indicating the localization of the parathyroid adenoma(s)
timeFrame: Surgery time
measure: 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
timeFrame: Surgery time
measure: 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
timeFrame: Surgery time
measure: 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
timeFrame: Surgery time
measure: Positive predictive value of Intraoperative probe-based confocal endomicroscopy in indicating the localization of the parathyroid adenoma(s)
timeFrame: Surgery time
measure: Negative predictive value of Intraoperative probe-based confocal endomicroscopy in indicating the localization of the parathyroid adenoma(s)
timeFrame: Surgery time
measure: Percentage of patients with minimally invasive parathyroidectomy approach
timeFrame: Surgery time
measure: Percentage of patients with classical cervicotomy parathyroidectomy approach
timeFrame: Surgery time
measure: Percentage of patients necessitating conversion from minimally invasive parathyroidectomy approach to classical cervicotomy
timeFrame: Surgery time
measure: Hyperparathyroidism recurrence rate
timeFrame: 1 year postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg
name: Mihaela IGNAT, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.