Overview

This trial is active, not recruiting.

Condition multigland disease in primary hyperparathyroidism
Treatment unilateral neck exploration
Sponsor Rambam Health Care Campus
Start date December 2011
End date June 2015
Trial size 70 participants
Trial identifier NCT01484379, parathyroid409-11-RMBCTIL

Summary

Following a personal observation and a retrospective analysis of the data, the investigators hypothesise that there is increased frequency of multiple gland disease in primary hyperparathyroidism in the elderly.

This study will include patients over the age of 65, diagnosed with primary hyperaprathyroidism, referred for surgery and suspected to have a single adenoma according to preoperative imaging. Surgery will begin with a focal parathyroid exploration as suspected followed by an exploration of the other gland at the same time. Data will be analysed to determine the frequency of multigland disease in this population.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
unilateral neck exploration of elderly with primary hyperparathyroidism
unilateral neck exploration
All elderly patients with primary hyperparathyroidism suspected to have a single gland disease will have a unilateral neck exploration following the index gland identification.

Primary Outcomes

Measure
Frequency of multigland disease in hyperparathyroidism in the elderly.
time frame: two years

Eligibility Criteria

Male or female participants at least 65 years old.

Inclusion Criteria: - patient with primary hyperparathyroidism. - patients with an indication for surgery. - Suspected adenoma on preop images. - minimum age of 65. Exclusion Criteria: - patients younger than 65. - cases where imaging didn't locate any adenoma. - patients who did not consent to participate in the study.

Additional Information

Official title Surgical Approach for Primary Hyperparathyroidism in the Elderly - a Prospective Study
Principal investigator Michal Mekel, M.D
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Rambam Health Care Campus.