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Peri-Operative Steroid Management in Patients (Steroid)

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. Identifier: NCT02084134
Recruitment Status : Completed
First Posted : March 11, 2014
Results First Posted : March 1, 2018
Last Update Posted : April 11, 2018
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:

During transsphenoidal resection of pituitary tumors and cysts, surgery is performed by a neurosurgeon and ear nose and throat surgeon. The pituitary tumor or cyst is reached by making a small hole in the back of the nose into the bottom of the skull. The surgeon is able to see the pituitary and tumor with an endoscope and remove the tumor through the hole.

Surgery on the pituitary can cause disruption in the secretion of ACTH and cause adrenal failure (lack of cortisol secretion) which can cause nausea, vomiting, low blood pressure, and rarely can be fatal. There is no consensus among endocrinologists and neurosurgeons about the use of perioperative steroids in pituitary patients. Traditionally, all patients undergoing pituitary surgery were given steroids before, during, and after surgery because of the assumption that there would be some compromise in the amount of ACTH released by the pituitary as a result of surgical trauma. Studies have failed to show, however, that ACTH secretion is in fact compromised during transsphenoidal pituitary microsurgery. As a result, there are some centers that routinely give perioperative steroids to all patients undergoing pituitary surgery and there are some centers that do not routinely give perioperative steroids. There are several retrospective and prospective studies that have addressed this issue and have shown that withholding perioperative steroids is safe, but there has never been a prospective study comparing the two approaches.

Objectives: The goal of this study is to prospectively compare two approaches to the perioperative management of patients undergoing transsphenoidal resection of a pituitary tumor or cyst. One protocol includes the routine use of perioperative steroids and the other does not. The investigators hypothesis, based on previous studies, is that patients who are adrenally sufficient do not routinely need to be treated with perioperative steroids. The investigators also hypothesize that the use of perioperative steroids may be associated with a higher rate of adverse outcomes

Condition or disease Intervention/treatment Phase
Pituitary Adenoma Pituitary Diseases Drug: hydrocortisone Drug: dexamethasone Not Applicable

Detailed Description:
Patients who are scheduled to undergo transsphenoidal resection for a pituitary tumor or cyst at the investigators institution will be screened prior to surgery for eligibility for this study. All patients deemed eligible will undergo a cosyntropin stimulation test to evaluate for adrenal insufficiency. Patients with adrenal insufficiency will be excluded from the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Use of Perioperative Steroids in Patients Undergoing Transsphenoidal Resection of Pituitary Tumors or Cysts
Study Start Date : March 2012
Actual Primary Completion Date : November 21, 2016
Actual Study Completion Date : December 31, 2016

Arm Intervention/treatment
Active Comparator: steroid treatment arm
Receives intravenous hydrocortisone 100mg and following surgery intravenous dexamethasone 0.5mg
Drug: hydrocortisone
100mg at the time of surgery
Other Name: intravenous hydrocortisone

Drug: dexamethasone
0.5mg every 6 hours for a total of four doses
Other Name: intravenous dexamethasone

No Intervention: non-steroid treatment
Subjects will not receive any steroids at the time of surgery or after surgery unless symptoms of adrenal insufficiency develop (i.e. nausea, vomiting, dizziness, or low blood pressure).

Primary Outcome Measures :
  1. Number of Participants With Adrenal Insufficiency [ Time Frame: 6 weeks following surgery ]
    Adrenal insufficiency was defined by a 30 or 60 min cortisol < 18 during a cosyntropin stimulation test

Secondary Outcome Measures :
  1. Percentage of Patients Discharged on Glucocorticoids [ Time Frame: 1 day (Day of hospital discharge) ]
    Patient charts were reviewed to identify patients who were discharged on prednisone

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Any adult patient with a pituitary adenoma or cyst (either non-functioning, prolactin secreting, growth hormone secreting, gonadotropin secreting, or TSH (Thyrotropin secreting hormone) scheduled to undergo transsphenoidal resection.

Exclusion Criteria:

  • Patients with Cushing's Disease (pituitary tumor which secretes ACTH)
  • Patients with a history of pituitary apoplexy (condition caused by hemorrhage into a pituitary adenoma which causes headache, double vision and hypopituitarism)
  • Patients on long term glucocorticoid therapy
  • Patients with adrenal insufficiency or who have not had their adrenal response evaluated prior to surgery

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 identifier (NCT number): NCT02084134

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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
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Principal Investigator: Julie M. Silverstein, M.D. Washington University School of Medicine

Additional Information:
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Responsible Party: Washington University School of Medicine Identifier: NCT02084134    
Other Study ID Numbers: 201110174
First Posted: March 11, 2014    Key Record Dates
Results First Posted: March 1, 2018
Last Update Posted: April 11, 2018
Last Verified: March 2018
Keywords provided by Washington University School of Medicine:
pituitary adenoma
Pituitary Tumor
transsphenoidal resection
pituitary cyst
Additional relevant MeSH terms:
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Pituitary Neoplasms
Pituitary Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Dexamethasone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs