Comparison of Surgical Approach to Endoscopic Pituitary Adenoma Resection

December 1, 2014 updated by: Dr. Luke Rudmik, University of Calgary

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • University of Calgary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 perimetry
    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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Posterior Septectomy
Patient will be randomized to a study arm. The patient will be blinded to the approach. The surgeon will have performed at least 10 procedures previous for each approach. The surgeon will maintain the following surgical practives: preservation of both middle turbinates, preservation of one superior turbinate (to minimize olfactory injury), elevation of a nasoseptal flap, the use of a combination of gelform, surgicel and nasapore dissolvable spacer placed within the surgical defect. These practices are all standard of care. Patient will start Neilmed high volume low pressure saline irrigation three times daily starting on post operative day five. Patients will receive prophylactic antibiotics for fourteen days post operatively.
Procedure: Posterior Septectomy
EXPERIMENTAL: Stamm Approach
Patient will be randomized a study arm. The patient will be blinded to the approach. The surgeon will have performed at least 10 procedures previous for each approach. The surgeon will maintain the following surgical practives: preservation of both middle turbinates, preservation of one superior turbinate (to minimize olfactory injury), elevation of a nasoseptal flap, the use of a combination of gelform, surgicel and nasapore dissolvable spacer placed within the surgical defect. These practices are all standard of care. Patient will start Neilmed high volume low pressure saline irrigation three times daily starting on post operative day five. Patients will receive prophylactic antibiotics for fourteen days post operatively.
Procedure: Stamm Approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of Life
Time Frame: Pre-operative and Post-operative (2 weeks, 6 weeks, 3 months and 6 months)
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.
Pre-operative and Post-operative (2 weeks, 6 weeks, 3 months and 6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-operative and Post-operative (2 weeks, 6 weeks, 3 months and 6 months)
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.
Pre-operative and Post-operative (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.
Pre-operative and Post-operative (2 weeks, 6 weeks, 3 months and 6 months)
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).
Pre-operative and Post-operative (6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

September 17, 2012

First Submitted That Met QC Criteria

September 17, 2012

First Posted (ESTIMATE)

September 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 1, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-24588

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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