Skip to main content
OpenTrials
Completed

NCT Number: NCT00006329

Comparison of Two Methods of Parathyroidectomy for Primary Hyperparathyroidism

Parathyroid glands are small endocrine glands that secrete a hormone which controls blood calcium levels. Primary hyperparathyroidism (PH) is a common disorder whereby one or more of these glands may enlarge and overproduce their hormone. Subsequently, the elevated blood calcium can cause many other symptoms and problems. The standard treatment is surgical removal of the gland(s) causing the disorder. The standard safe and effective operation has been the bilateral open parathyroid exploration (BOPE). A newer procedure using a radioactive compound that concentrates in the parathyroid glands allows a more limited operation to find and remove the causative gland [Minimally-Invasive Radioguided Parathyroidectomy (MIRP)]. The radiation exposure is minimal and safe. Although the operation may prove to be less expensive, it is not certain whether it is as effective or as safe as BOPE. This study serves to directly compare the costs, the effectiveness, and the safety associated with each type of operation. All patients (adolescents and older) with PH are candidates to participate. The participants will be randomly assigned to the MIRP group or the BOPE group independently of patient or physician preferences. MIRP patients will undergo a sestamibi nuclear medicine scan to attempt to localize the specific parathyroid gland causing the hyperparathyroidism and subsequently a limited operation under local anesthesia to remove the single gland. Parathyroid hormone levels will be measured during the operation to ensure that the patient has been cured. If not, the standard BOPE procedure will be completed. The total cost of the care will be tracked for each group. Careful testing for complications such as vocal cord dysfunction will be done. General Health status and pain levels will be measured before and after each operation. Patient satisfaction with the operation and care will also be assessed.

Completed

Looking for future studies?

Notify Me

Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Univ. of Michigan Hosp, Dept. of Surgery

Ann Arbor, Michigan, 48109-0331, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Elevated serum calcium concentration on at least 2 occasions; if the value is <11.0 mg/dL, it must have been present for at least 6 months; if the serum albumin concentration is not normal, the ionized calcium level will be measured and must be elevated.
  • Nephrolithiasis or documented bone mineral density less than 2.5 Standard Deviations below age matched means.
  • Elevated or non-suppressed serum intact parathyroid hormone level

Treatment and study plan

Minimally invasive radioguided parathyroidectomy

Procedure

Sponsors and collaborators

Lead sponsor

National Center for Research Resources (NCRR)

Nih

Registry information

Important dates

First posted
Oct 5, 2000
Registry last updated
Jun 24, 2005

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.

Published trials that share one or more normalized conditions with this study.