Back to resultsSurgical Outcomes in Patients With Primary Hyperparathyroidism and Unclear Preoperative Localisation Studies
Primary Purpose
Primary Hyperparathyroidism
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Parahtyroidectomy
Sponsored by
About this trial
This is an interventional treatment trial for Primary Hyperparathyroidism
Eligibility Criteria
Inclusion Criteria:
- Patients with primary hyperparathyroidism
Exclusion Criteria:
- Patients with concomitant thyroid disease
Sites / Locations
- Policlinico di Monserrato
- Policlinico di Monserrato
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Concordant preoperative studies
Unclear preoperative studies
Arm Description
Patients with concordant neck ultrasound and MIBI scan
Patients with discordant or negative neck ultrasound and MIBI scan
Outcomes
Primary Outcome Measures
Surgical failure
Incidence of persistent hyperparathyroidism
Secondary Outcome Measures
Full Information
NCT ID
NCT04740502
First Posted
February 1, 2021
Last Updated
February 4, 2021
Sponsor
University of Cagliari
1. Study Identification
Unique Protocol Identification Number
NCT04740502
Brief Title
Surgical Outcomes in Patients With Primary Hyperparathyroidism and Unclear Preoperative Localisation Studies
Official Title
Surgical Approach and Outcomes in Patients With Primary Hyperparathyroidism and Unclear Preoperative Localisation Studies
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2008 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cagliari
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hyperparathyroidism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
242 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Concordant preoperative studies
Arm Type
Other
Arm Description
Patients with concordant neck ultrasound and MIBI scan
Arm Title
Unclear preoperative studies
Arm Type
Other
Arm Description
Patients with discordant or negative neck ultrasound and MIBI scan
Intervention Type
Procedure
Intervention Name(s)
Parahtyroidectomy
Intervention Description
Parathyroidectomy
Primary Outcome Measure Information:
Title
Surgical failure
Description
Incidence of persistent hyperparathyroidism
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with primary hyperparathyroidism
Exclusion Criteria:
Patients with concomitant thyroid disease
Facility Information:
Facility Name
Policlinico di Monserrato
City
Monserrato
State/Province
Cagliari
ZIP/Postal Code
09040
Country
Italy
Facility Name
Policlinico di Monserrato
City
Monserrato
State/Province
CA
ZIP/Postal Code
09042
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Surgical Outcomes in Patients With Primary Hyperparathyroidism and Unclear Preoperative Localisation Studies
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