Comparison of Cervical Ultrasound and Echoscintigraphy for Preoperative Localization Diagnosis in Primary Hyperparathyroidism

Not Applicable

• Conditions: Primary Hyperparathyroidism
• Interventions: Other: cervical ultrasound

• Registration Number: NCT03605472
• Lead Sponsor: CHU de Reims

Brief Summary

The biological diagnosis of the primary hyperparathyroidism is now facilitated by the reliability of the balance of phosphate and calcium and the dosage of parathyroid hormone (PTH).

This diagnosis of preoperative localization is important as surgery are now targeted to the responsible lesion.

The "gold standard" for this localization is the cervical ultrasound exploring the usual sites of adenomas and a MIBI scintigraphy (the parathyroid adenoma significantly concentrating this cell marker).

However, the diagnosis of preoperative localization remains a subject of discussion as to the most appropriate tests. Indeed, the morphological diagnosis is performed at the ultrasound stage in more than half the cases. It is the new performance of this morphological examination that makes it possible to obtain these results.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-05
• Status Verified: 2018-07
• Study First Submitted: 2018-07-20
• Study First Submitted QC: 2018-07-20
• Last Update Submitted: 2018-07-20
• Study First Posted: 2018-07-30
• Last Update Posted: 2018-07-30
• Primary Completion: 2019-10-05
• Study Completion: 2020-03-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients with primary hyperparathyroidism with surgery indication
• Age > 18yo

Exclusion Criteria

• surgical contraindication
• medical treatment by cinacalcet
• non sporadic hyperparathyroidism
• Age <18yo
• Protected by the law

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients	cervical ultrasound	-

Primary Outcome Measures

Name	Time	Method
Adenoma parathyroid diagnosed using cervical ultrasound	Day 0	Adenoma parathyroid diagnosed using cervical ultrasound. Cervical ultrasound will be realized by a endocrinologist trained in the cervical ultrasound and not informed of the results of the echoscintigraphy
Adenoma parathyroid diagnosed using echoscintigraphy	Day 0	Adenoma parathyroid diagnosed using echoscintigraphy. Echoscintigraphy will be realized by a nuclear physician not informed of the results of the cervical ultrasound
Adenoma parathyroid diagnosed using anatomopathology	Day 0	Adenoma parathyroid diagnosed by anatomopathologist, after surgery.

Trial Locations

Locations (1)

Damien JOLLY; 🇫🇷 Reims, France