Surgical Approach for Primary Hyperparathyroidism in the Elderly

Multigland Disease in Primary Hyperparathyroidism Clinical Trial

Official title:

Surgical Approach for Primary Hyperparathyroidism in the Elderly - a Prospective Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01484379
• Other study ID #: parathyroid409-11-RMBCTIL
• Status: Withdrawn
• Phase: N/A
• First received: December 1, 2011
• Last updated: August 24, 2017
• Start date: December 2011
• Est. completion date: November 2015

Study information

• Verified date: August 2017
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Multigland Disease in Primary Hyperparathyroidism

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

References & Publications (3)

Kebebew E, Duh QY, Clark OH. Parathyroidectomy for primary hyperparathyroidism in octogenarians and nonagenarians: a plea for early surgical referral. Arch Surg. 2003 Aug;138(8):867-71. — View Citation

Shin SH, Holmes H, Bao R, Jimenez C, Kee SS, Potylchansky E, Lee JE, Evans DB, Perrier ND. Outpatient minimally invasive parathyroidectomy is safe for elderly patients. J Am Coll Surg. 2009 Jun;208(6):1071-6. doi: 10.1016/j.jamcollsurg.2009.01.048. Epub 2009 Apr 17. — View Citation

Udén P, Chan A, Duh QY, Siperstein A, Clark OH. Primary hyperparathyroidism in younger and older patients: symptoms and outcome of surgery. World J Surg. 1992 Jul-Aug;16(4):791-7; discussion 798. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of multigland disease in hyperparathyroidism in the elderly.		two years