NCT04013100

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
235

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
Last Updated

January 9, 2024

Status Verified

January 1, 2024

Enrollment Period

5 years

First QC Date

July 5, 2019

Last Update Submit

January 5, 2024

Conditions

Primary Hyperparathyroidism

Keywords

primary hyperparathyroidismparathyroidectomy3D reconstructionVirtual neck exploration

Outcome Measures

Primary Outcomes (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

    (true positives + true negatives) / number of patients

    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

    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

    Surgery time

  • Positive predictive value of 3D-VNE (virtual neck exploration) in indicating the localization of the parathyroid adenoma(s)

    Surgery time

  • Negative predictive value of 3D-VNE (virtual neck exploration) in indicating the localization of the parathyroid adenoma(s)

    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

    Surgery time

  • +38 more secondary outcomes

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 28620896BACKGROUND

  • 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.

    PMID: 23558758BACKGROUND

  • 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.

    PMID: 22970967BACKGROUND

  • 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.

    PMID: 23682370BACKGROUND

MeSH Terms

Conditions

Hyperparathyroidism, Primary

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Study Officials

  • Mihaela IGNAT, MD

    Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2019

First Posted

July 9, 2019

Study Start

January 1, 2014

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

January 9, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share