Adrenalectomy for Solitary Adrenal Gland Metastases

Adrenal Gland Metastases Clinical Trial

Official title:

The Use of Adrenalectomy in Patients With Solitary Adrenal Gland Metastases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01135238
• Other study ID #: 09-007747
• Status: Completed
• Phase: N/A
• First received: June 1, 2010
• Last updated: December 14, 2011
• Start date: November 2009
• Est. completion date: November 2010

Study information

• Verified date: December 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The adrenal glands are one of the most common organs involved in metastatic disease. Metastases are the second most common type of adrenal mass, second only to adenomas. It is a frequent finding during autopsy with a reported rate as high as 27% in patients with known primary malignancy. Although several studies have found an increased survival in patients who undergo resection of solitary adrenal metastases the indications for adrenalectomy in cases of metastatic adrenal tumor remain controversial. Collinson et al reported an increased survival in patients with melanoma. Median survival was 16 months for patients who underwent adrenalectomy compared to 5 months for patients with documented adrenal metastases treated non surgically.

The aim of this study is to compare retrospectively in case and control study, performing adrenalectomy, open or laparoscopic, versus supportive treatment for patients with solitary adrenal gland metastases. The investigators will review charts of patients between January 1994 and November 2009 who had adrenal gland metastases. The variables the inevstigators will compare are mortality, morbidity, primary tumour sites, histological cell type, age, tumour size, presence of synchronous metastases, mean time from diagnosis of primary tumor to treatment of adrenal metastases, indication for adrenalectomy, partial versus total adrenalectomy, suspected versus confirmed metastatic disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Metastatic disease to the adrenal gland

Exclusion Criteria:

• Primary adrenal neoplasm

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Adrenal Gland Metastases
• Adrenal Gland Neoplasms
• Adrenalectomy
• Neoplasm Metastasis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adrenalectomy improves overall survival in patients with solitary metastasis	Survival data compared to historic controls	25 years	No
Secondary	Adrenalectomy can be performed with minimal morbidity in patients with metastatic lesions to the adrenal gland.	Operative outcomes compared to historic control patients undergoing adrenalectomy for non-maligant disorders.	25 years	No