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

18 Years
Open (Enrolling)
Pituitary Adenoma, Posterior Septectomy, Stamm Approach, Quality of Life

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Trial Information

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

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 studies have demonstrated that the endoscopic approach for pituitary adenoma
resection results in improved disease-specific quality of life (QoL) and general QoL. All
studies have utilized the posterior septectomy approach which involves removing the
posterior nasal septum to create a common posterior nasal cavity. The open posterior nasal
cavity provides excellent surgical access to the sphenoid sinus and pituitary gland.
Disadvantages of the posterior septectomy approach include the permanent posterior septal
perforation which may predispose to postoperative crusting and epistaxis. A recent article
by Stamm et al. described a novel endoscopic approach whereby the posterior septal mucosa is
preserved while still providing excellent access to the sphenoid. The primary advantage of
this approach is preventing a posterior septal defect, however disadvantages include being a
more challenging technique and the potential for reduced surgical visualization.
Furthermore, there is still a risk of a septal perforation due to intraoperative trauma and
significant postoperative crusting which often develops along the surface of the healing
septal mucosa. Both endoscopic approaches have inherent advantages and disadvantages and
there has been no study comparing these approaches. Surgeons performing endoscopic pituitary
tumor resections utilize both approaches and neither is considered the standard of care.

The purpose of this randomized, single-blinded study is to determine the clinical outcomes
between the posterior septectomy and Stamm approach for endoscopic pituitary adenoma
resection. We hypothesize that there will be no difference in disease-specific QoL and
general QoL between the two surgical approaches.

Inclusion Criteria:

- Age > 18 years old

- Diagnosis of a pituitary adenoma requiring resection defined as pituitary lesion with
any of the following:

1. Neuroimaging or clinical evidence of apoplexy

2. Decline in central visual acuity worse than (best-corrected) Snellen equivalent
of 20/25 in either eye

3. clinically significant visual field loss as determined by Humphrey or Goldmann

4. Clinically significant cranial nerve deficit

5. Clinically relevant neuroendocrine deficit

6. Intolerance of optimal medical management

- Patient electing endoscopic resection approach

Exclusion Criteria:

- Concurrent chronic rhinosinusitis

- Revision pituitary adenoma resections

- Severe medical co-morbidities with the inability to undergo general anesthesia

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Change in Quality of Life

Outcome Description:

To determine the change in quality of life scores between the two groups at 2 weeks, 6 weeks, 3 months and 6 months using the anterior skull base nasal inventory questionnaire, the SinoNasal outcome test-22 questionnaire and the EQ-5D questionnaire.

Outcome Time Frame:

Pre-operative and Post-operative (2 weeks, 6 weeks, 3 months and 6 months)

Safety Issue:


Principal Investigator

Luke Rudmik, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Calgary


Canada: Ethics Review Committee

Study ID:




Start Date:

September 2012

Completion Date:

June 2014

Related Keywords:

  • Pituitary Adenoma
  • Posterior Septectomy
  • Stamm Approach
  • Quality of Life
  • Adenoma
  • Pituitary Neoplasms