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

Sponsor

University of Cagliari (Other)

Overall Status

Completed

CT.gov ID

NCT04740502

Collaborator

(none)

242

Enrollment

Locations

Arms

156

Actual Duration (Months)

121

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Hyperparathyroidism	Procedure: Parahtyroidectomy	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

242 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Concordant preoperative studies Patients with concordant neck ultrasound and MIBI scan	Procedure: Parahtyroidectomy Parathyroidectomy
Other: Unclear preoperative studies Patients with discordant or negative neck ultrasound and MIBI scan	Procedure: Parahtyroidectomy Parathyroidectomy

Arm

Intervention/Treatment

Other: Concordant preoperative studies

Patients with concordant neck ultrasound and MIBI scan

Procedure: Parahtyroidectomy

Parathyroidectomy

Other: Unclear preoperative studies

Patients with discordant or negative neck ultrasound and MIBI scan

Procedure: Parahtyroidectomy

Parathyroidectomy

Outcome Measures

Primary Outcome Measures

Surgical failure [6 months]
Incidence of persistent hyperparathyroidism

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with primary hyperparathyroidism

Exclusion Criteria:

Patients with concomitant thyroid disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Policlinico di Monserrato	Monserrato	Cagliari	Italy	09040
2	Policlinico di Monserrato	Monserrato	CA	Italy	09042

Sponsors and Collaborators

University of Cagliari

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fabio Medas, Assistant Professor, University of Cagliari

ClinicalTrials.gov Identifier:

NCT04740502

Other Study ID Numbers:

PHP-DISC

First Posted:

Feb 5, 2021

Last Update Posted:

Feb 9, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hyperparathyroidism

Hyperparathyroidism, Primary

Study Results

No Results Posted as of Feb 9, 2021