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Adrenalectomy for Solitary Adrenal Gland Metastases

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01135238
First Posted: June 2, 2010
Last Update Posted: December 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mayo Clinic
June 1, 2010
June 2, 2010
December 16, 2011
November 2009
November 2010   (Final data collection date for primary outcome measure)
Adrenalectomy improves overall survival in patients with solitary metastasis [ Time Frame: 25 years ]
Survival data compared to historic controls
Same as current
Complete list of historical versions of study NCT01135238 on ClinicalTrials.gov Archive Site
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.
Same as current
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Adrenalectomy for Solitary Adrenal Gland Metastases
The Use of Adrenalectomy in Patients With Solitary Adrenal Gland Metastases

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.

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Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample
Patients undergoing adrenalectomy for metastatic disease.
  • Adrenal Gland Metastases
  • Adrenalectomy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
168
November 2010
November 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Metastatic disease to the adrenal gland

Exclusion Criteria:

  • Primary adrenal neoplasm
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01135238
09-007747
Yes
Not Provided
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Melanie L. Richards, M.D., Associate Professor of Surgery, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Melanie L Richards, MD Mayo Clinic
Mayo Clinic
December 2011
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