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

NCT ID: NCT04740502

Last Updated: 2021-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-01
• Study Completion Date: 2020-12-31

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.

Conditions

Primary Hyperparathyroidism

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Concordant preoperative studies

Patients with concordant neck ultrasound and MIBI scan

Group Type: OTHER

Parahtyroidectomy

Intervention Type: PROCEDURE

Parathyroidectomy

Unclear preoperative studies

Patients with discordant or negative neck ultrasound and MIBI scan

Group Type: OTHER

Parahtyroidectomy

Intervention Type: PROCEDURE

Parathyroidectomy

Interventions

Parahtyroidectomy

Parathyroidectomy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with primary hyperparathyroidism

Exclusion Criteria

• Patients with concomitant thyroid disease

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cagliari

OTHER

Sponsor Role: lead

Responsible Party

Fabio Medas

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Policlinico di Monserrato

Monserrato, Cagliari, Italy

Policlinico di Monserrato

Monserrato, CA, Italy

Countries

Italy

Other Identifiers

PHP-DISC

Identifier Type: -

Identifier Source: org_study_id