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

Surgical Approach and 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.

Study Overview

• Status: Completed
• Conditions: Primary Hyperparathyroidism
• Intervention / Treatment: Procedure: Parahtyroidectomy

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 Type: Interventional
• Enrollment (Actual): 242
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • CA
    • Monserrato, CA, Italy, 09042
      • Policlinico di Monserrato
  • Cagliari
    • Monserrato, Cagliari, Italy, 09040
      • Policlinico di Monserrato

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with primary hyperparathyroidism

Exclusion Criteria:

• Patients with concomitant thyroid disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Cagliari

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2008
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: February 1, 2021
• First Submitted That Met QC Criteria: February 1, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Parathyroid Diseases; Hyperparathyroidism; Hyperparathyroidism, Primary
• Other Study ID Numbers: PHP-DISC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No