Adrenalectomy for Solitary Adrenal Gland Metastases

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01135238
First received: June 1, 2010
Last updated: December 14, 2011
Last verified: December 2011
  Purpose

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
Adrenal Gland Metastases
Adrenalectomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Use of Adrenalectomy in Patients With Solitary Adrenal Gland Metastases

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Adrenalectomy improves overall survival in patients with solitary metastasis [ Time Frame: 25 years ] [ Designated as safety issue: No ]
    Survival data compared to historic controls


Secondary Outcome Measures:
  • Adrenalectomy can be performed with minimal morbidity in patients with metastatic lesions to the adrenal gland. [ Time Frame: 25 years ] [ Designated as safety issue: No ]
    Operative outcomes compared to historic control patients undergoing adrenalectomy for non-maligant disorders.


Enrollment: 168
Study Start Date: November 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01135238

Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Melanie L Richards, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Melanie L. Richards, M.D., Associate Professor of Surgery, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01135238     History of Changes
Other Study ID Numbers: 09-007747
Study First Received: June 1, 2010
Last Updated: December 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
adrenalectomy
metastasis
morbidity
mortality
survival

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on July 31, 2014