Clinical Trial: Comparison of Surgical Approach to Endoscopic Pituitary Adenoma Resection

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Comparison of the Posterior Septectomy and Stamm Approach to Endoscopic Pituitary Adenoma Resection: A Randomized, Single-blind Trial

Brief Summary: The purpose of this study is to determine if there is a significant difference in sinonasal disease specific quality of life and utility scores between patients undergoing the posterior septectomy or Stamm approach during endoscopic pituitary adenoma resection.

Detailed Summary:

Pituitary adenoma's represent 10 to 25% of all central nervous system (CNS) neoplasms and have an estimated population prevalence of 94 per 100,000. Asymptomatic adenomas go largely undetected since there is no screening protocol implemented with the purpose for early identification. Asymptomatic adenomas can be detected incidentally on CNS imaging for other indications in approximately 10% of studies and rarely require surgical intervention. In 2011, the Endocrine Society published practice guidelines on the management of pituitary incidentalomas and provided the surgical indications. Incidental microadenoma's (< 10 mm) rarely need surgical intervention, however, incidental macroadenoma's (> 10 mm) often required surgical resection due to the proximity of the optic nerves and chiasm.

Most symptomatic pituitary adenomas require transnasal transsphenoid surgical resection. Due to the potential for hormone secretion and location to vital structures such as the optic chiasm/nerves, carotid artery, and cavernous sinus, management of symptomatic pituitary adenomas often require a multi-disciplinary team involving neurosurgery, otolaryngology, neuroophthalmology, and endocrinology. Traditionally the microscope was used for visualization during pituitary tumor surgery, however with recent technologic advances, the endoscopic approach has largely replaced the microscopic approach. A recent systematic review and meta-analysis compared the microscopic and endoscopic approaches and have demonstrated that the endoscopic approach results in a significant reduction in the rate of cerebral spinal fluid (CSF) leak, improved tumor resection, improved patient comfort, and reduced hospital length of stay. Furthermore, the endoscopic approach appears to provide an overall cost savings compared to the microscopic approach.

Several recent
Sponsor: University of Calgary

Current Primary Outcome: Change in Quality of Life [ Time Frame: Pre-operative and Post-operative (2 weeks, 6 weeks, 3 months and 6 months) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change in Symptom Score [ Time Frame: Pre-operative and Post-operative (2 weeks, 6 weeks, 3 months and 6 months) ]
  To determine the change in symptom score between the two groups at 2 weeks, 6 weeks, 3 months and 6 months using the VAS Nasal Symptom score.
• Change in Utility Score [ Time Frame: Pre-operative and Post-operative (2 weeks, 6 weeks, 3 months and 6 months) ]
  To determine the change in utility score between the two groups at 2 weeks, 6 weeks, 3 months and 6 months.
• Change in Endoscopic Sinus Score [ Time Frame: Pre-operative and Post-operative (2 weeks, 6 weeks, 3 months and 6 months) ]
  To determine the change in endoscopic sinus score between the two groups at 2 weeks, 6 weeks, 3 months and 6 months using the endoscopic grading - Using both the Lund-Kennedy and POSE endoscopic scoring system.
• Change in Olfaction [ Time Frame: Pre-operative and Post-operative (6 months) ]
  To determine the change in olfaction between the two groups at 6 months using the Smell Identification Test (SIT).

Original Secondary Outcome: Same as current

Information By: University of Calgary

Dates:
Date Received: September 17, 2012
Date Started: September 2012
Date Completion:
Last Updated: December 1, 2014
Last Verified: December 2014