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

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.

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Key information

Conditions

Primary Hyperparathyroidism Endocrine System Diseases Hyperparathyroidism Hyperparathyroidism, Primary Parathyroid Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Policlinico di Monserrato, Monserrato, CA, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with primary hyperparathyroidism

Exclusion criteria

Patients with concomitant thyroid disease

Treatment and study plan

Parahtyroidectomy

Procedure

Parathyroidectomy

Primary outcomes

Surgical failure

Time frame: 6 months

Incidence of persistent hyperparathyroidism

Sponsors and collaborators

Lead sponsor

University of Cagliari

Other

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2019
Study completion: 2020
First posted: Feb 5, 2021
Registry last updated: Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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