Trial record 11 of 148 for:    Pituitary Tumors

Pituitary Steroid Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT02084134
First received: March 5, 2014
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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 Intervention
Pituitary Adenoma
Pituitary Diseases
Drug: hydrocortisone
Drug: dexamethasone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Use of Perioperative Steroids in Patients Undergoing Transsphenoidal Resection of Pituitary Tumors or Cysts

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Incidence of adrenal insufficiency in follow-up [ Time Frame: 6 weeks following surgery ] [ Designated as safety issue: Yes ]
    Assessed by the cosyntropin stimulation test


Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 6 weeks post-operative ] [ Designated as safety issue: No ]
    As measured by SF-36 questionnaire and Headache Pain Scale

  • Rate of perioperative complications [ Time Frame: Participants will be followed for the perioperative period, an expected average of 8 weeks ] [ Designated as safety issue: Yes ]
    Length of hospital stay, bleeding, infection, hyperglycemia, development of diabetes insipidus, average blood glucose

  • Percentage of Patients discharged on glucocorticoids [ Time Frame: 1 day (Day of hospital discharge) ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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) 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
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: NCT02084134

Contacts
Contact: Julie M Silverstein, MD 314-747-3979 jsilvers@dom.wustl.edu
Contact: Stacy Hurst, RN 314-747-3294 shurst@dom.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Julie M. Silverstein, MD    314-747-3979    jsilvers@dom.wustl.edu   
Principal Investigator: Julie M. Silverstein, M.D.         
Sub-Investigator: Michael Chicoine, MD         
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:
Publications:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02084134     History of Changes
Other Study ID Numbers: 201110174
Study First Received: March 5, 2014
Last Updated: March 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
pituitary adenoma
Pituitary Tumor
transsphenoidal resection
pituitary cyst

Additional relevant MeSH terms:
Pituitary Neoplasms
Pituitary Diseases
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
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hypothalamic Diseases
Endocrine System Diseases
Dexamethasone acetate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Dexamethasone
Hydrocortisone
Dexamethasone 21-phosphate
BB 1101
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014