NCT04740502

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
242

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

12 years

First QC Date

February 1, 2021

Last Update Submit

February 4, 2021

Conditions

Primary Hyperparathyroidism

Outcome Measures

Primary Outcomes (1)

  • Surgical failure

    Incidence of persistent hyperparathyroidism

    6 months

Study Arms (2)

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

ParahtyroidectomyPROCEDURE

Parathyroidectomy

Concordant preoperative studiesUnclear preoperative studies

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with primary hyperparathyroidism

You may not qualify if:

  • Patients with concomitant thyroid disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Policlinico di Monserrato

Monserrato, Cagliari, 09040, Italy

Location

Policlinico di Monserrato

Monserrato, CA, 09042, Italy

Location

MeSH Terms

Conditions

Hyperparathyroidism, Primary

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 1, 2021

First Posted

February 5, 2021

Study Start

January 1, 2008

Primary Completion

December 31, 2019

Study Completion

December 31, 2020

Last Updated

February 9, 2021

Record last verified: 2021-02

Locations

IT(2)