Surgical Outcomes in Patients With Primary Hyperparathyro... | NCT04740502

Studies
Surgical Outcomes in Patients With Primary Hyperparathyroidism and Unclear Preoperative Localisation Studies

NCT04740502

Sponsor

University of Cagliari

Status

Completed

Last Update Posted

Feb 9, 2021Actual

Enrollment

242Actual

Phase

Not Applicable

Conditions

Primary Hyperparathyroidism

Interventions

Parahtyroidectomy

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2008Actual

Primary Completion Date

Dec 31, 2019Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

Feb 1, 2021

First Submission Date that Met QC Criteria

Feb 1, 2021

First Posted Date

Feb 5, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2021

Last Update Posted Date

Feb 9, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Fabio Medas, Assistant Professor, University of CagliariPrincipal Investigator

Lead Sponsor

University of CagliariOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

242Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Concordant preoperative studies	Other	Patients with concordant neck ultrasound and MIBI scan	Procedure: Parahtyroidectomy
Unclear preoperative studies	Other	Patients with discordant or negative neck ultrasound and MIBI scan	Procedure: Parahtyroidectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Parahtyroidectomy	Procedure	Parathyroidectomy	Concordant preoperative studies Unclear preoperative studies

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Surgical failure	Incidence of persistent hyperparathyroidism	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with primary hyperparathyroidism

Exclusion Criteria:

Patients with concomitant thyroid disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Policlinico di Monserrato		Monserrato	Cagliari	09040	Italy
Policlinico di Monserrato

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D049950	Hyperparathyroidism, Primary

Ancestor Terms

ID	Term
D006961	Hyperparathyroidism
D010279	Parathyroid Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided