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Adrenalectomy for Solitary Adrenal Gland Metastases

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ClinicalTrials.gov Identifier: NCT01135238
Recruitment Status : Completed
First Posted : June 2, 2010
Last Update Posted : December 16, 2011
Sponsor:
Information provided by:
Mayo Clinic

Study Description
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Brief 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.


Condition or disease
Adrenal Gland Metastases Adrenalectomy

Study Design
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Study Type : Observational
Actual Enrollment : 168 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Use of Adrenalectomy in Patients With Solitary Adrenal Gland Metastases
Study Start Date : November 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Adrenalectomy improves overall survival in patients with solitary metastasis [ Time Frame: 25 years ]
    Survival data compared to historic controls


Secondary Outcome Measures :
  1. Adrenalectomy can be performed with minimal morbidity in patients with metastatic lesions to the adrenal gland. [ Time Frame: 25 years ]
    Operative outcomes compared to historic control patients undergoing adrenalectomy for non-maligant disorders.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing adrenalectomy for metastatic disease.
Criteria

Inclusion Criteria:

  • Metastatic disease to the adrenal gland

Exclusion Criteria:

  • Primary adrenal neoplasm
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01135238


Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Melanie L Richards, MD Mayo Clinic
More Information
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Responsible Party: Melanie L. Richards, M.D., Associate Professor of Surgery, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01135238    
Other Study ID Numbers: 09-007747
First Posted: June 2, 2010    Key Record Dates
Last Update Posted: December 16, 2011
Last Verified: December 2011
Keywords provided by Mayo Clinic:
adrenalectomy
metastasis
morbidity
mortality
survival
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Adrenal Gland Neoplasms
Neoplastic Processes
Neoplasms
 Pathologic Processes
Endocrine Gland Neoplasms
Neoplasms by Site
Adrenal Gland Diseases
Endocrine System Diseases