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

IHU Strasbourg

Status: Terminated

Conditions: Primary Hyperparathyroidism

Treatments: Diagnostic Test: 3D-VNE (virtual neck exploration)

Study type: Observational

Funder types: Other

Identifiers

NCT04013100

18-006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 235 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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