Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT04740502
Status:
COMPLETED
Last Update Posted:
2021-02-09
First Post:
2021-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surgical Outcomes in Patients With Primary Hyperparathyroidism and Unclear Preoperative Localisation Studies
Sponsor:
University of Cagliari
Organization:
Study Overview
Official Title:
Surgical Approach and Outcomes in Patients With Primary Hyperparathyroidism and Unclear Preoperative Localisation Studies
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: