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.

ClinicalTrials.gov Identifier: NCT02084134

Recruitment Status : Completed

First Posted : March 11, 2014

Results First Posted : March 1, 2018

Last Update Posted : April 11, 2018

Sponsor:

Information provided by (Responsible Party):

Washington University School of Medicine

Study Description

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.

Study Design


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

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Familial isolated pituitary adenoma

MedlinePlus related topics: Pituitary Disorders Pituitary Tumors

Drug Information available for: Dexamethasone Hydrocortisone acetate Hydrocortisone Hydrocortisone sodium succinate Hydrocortisone cypionate Hydrocortisone valerate Hydrocortisone probutate Proctofoam-HC

U.S. FDA Resources

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures :

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 :

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

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Criteria

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

Contacts and Locations

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): NCT02084134

Locations


United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

Investigators


Principal Investigator:	Julie M. Silverstein, M.D.	Washington University School of Medicine

More Information

Additional Information:

Julie M. Silverstein, M.D. This link exits the ClinicalTrials.gov site

Washington University School of Medicine, Research Participant Registry This link exits the ClinicalTrials.gov site

Publications:

Agha A, Liew A, Finucane F, Baker L, O'Kelly P, Tormey W, Thompson CJ. Conventional glucocorticoid replacement overtreats adult hypopituitary patients with partial ACTH deficiency. Clin Endocrinol (Oxf). 2004 Jun;60(6):688-93.

Marko NF, Hamrahian AH, Weil RJ. Immediate postoperative cortisol levels accurately predict postoperative hypothalamic-pituitary-adrenal axis function after transsphenoidal surgery for pituitary tumors. Pituitary. 2010 Sep;13(3):249-55. doi: 10.1007/s11102-010-0227-6.

Marko NF, Gonugunta VA, Hamrahian AH, Usmani A, Mayberg MR, Weil RJ. Use of morning serum cortisol level after transsphenoidal resection of pituitary adenoma to predict the need for long-term glucocorticoid supplementation. J Neurosurg. 2009 Sep;111(3):540-4. doi: 10.3171/2008.12.JNS081265.

Hout WM, Arafah BM, Salazar R, Selman W. Evaluation of the hypothalamic-pituitary-adrenal axis immediately after pituitary adenomectomy: is perioperative steroid therapy necessary? J Clin Endocrinol Metab. 1988 Jun;66(6):1208-12.

Bhansali A, Dutta P, Bhat MH, Mukherjee KK, Rajput R, Bhadada S. Rational use of glucocorticoid during pituitary surgery--a pilot study. Indian J Med Res. 2008 Sep;128(3):294-9.

Inder WJ, Hunt PJ. Glucocorticoid replacement in pituitary surgery: guidelines for perioperative assessment and management. J Clin Endocrinol Metab. 2002 Jun;87(6):2745-50. Review.


Responsible Party:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT02084134 History of Changes
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:


Pituitary Diseases Pituitary Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Hypothalamic Neoplasms Supratentorial Neoplasms Brain Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Adenoma Hypothalamic Diseases Brain Diseases	Central Nervous System Diseases Nervous System Diseases Endocrine System Diseases Dexamethasone acetate Hydrocortisone 17-butyrate 21-propionate Hydrocortisone acetate Cortisol succinate Dexamethasone Hydrocortisone BB 1101 Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs

To Top