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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04740502
Other study ID # PHP-DISC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2008
Est. completion date December 31, 2020

Study information

Verified date February 2021
Source University of Cagliari
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Although some surgeons still consider bilateral neck exploration as the best approach for primary hyperparathyroidism, nowadays most of them perceive the mini-invasive parathyroidectomy (MIP) as the best option for patients with concordant preoperative studies. Nevertheless, the consensus is heterogeneous for patients with unclear localisation studies, with some surgeons deeming BNE as mandatory and others suggesting that a mini-invasive approach is still possible if combined with IOPTH monitoring. In our research, we focused on patients with unclear preoperative localisation studies, to better understand the factors that can determine discordant or negative results between US and MIBI scan, in order to choose the best surgical approach and to evaluate the outcomes in this kind of patients.


Description:

This is an unicentric, retrospective study on patients who underwent surgery for PHP from January 2004 to June 2020 at our Department of General and Endocrine surgery, which is a tertiary referral centre for parathyroid disease. Ethical approval was released from our Local Independent Ethical Committee. Patients involved in the study subjects gave informed consent to the work. In our study, we included only patients who underwent both US and MIBI preoperatively. The exclusion criteria were the association of total or partial thyroidectomy planned preoperatively for thyroid disease, reoperative surgery for persistent or recurrent PHP, and incomplete data or follow-up. The primary aims of this study were: - To identify predictive factors of unclear preoperative localisation studies. - To evaluate if a mini-invasive approach is feasible in this kind of patients, considering the incidence of persistent PHP as the main outcome. The secondary outcomes were: - To assess the role of IOPTH assay in patients with unclear localisation studies. - To evaluate the accuracy of preoperative localisation studies in our series, particularly in patients with discordant or negative US and MIBI scan.


Recruitment information / eligibility

Status Completed
Enrollment 242
Est. completion date December 31, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients with primary hyperparathyroidism Exclusion Criteria: - Patients with concomitant thyroid disease

Study Design


Intervention

Procedure:
Parahtyroidectomy
Parathyroidectomy

Locations

Country Name City State
Italy Policlinico di Monserrato Monserrato Cagliari
Italy Policlinico di Monserrato Monserrato CA

Sponsors (1)

Lead Sponsor Collaborator
University of Cagliari

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Surgical failure Incidence of persistent hyperparathyroidism 6 months
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