Comparison of Surgical Approach to Endoscopic Pituitary Adenoma Resection

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by University of Calgary
Sponsor:
Information provided by (Responsible Party):
Dr. Luke Rudmik, University of Calgary
ClinicalTrials.gov Identifier:
NCT01689064
First received: September 17, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Pituitary Adenoma
Posterior Septectomy
Stamm Approach
Quality of Life
Procedure: Stamm Approach
Procedure: Posterior Septectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of the Posterior Septectomy and Stamm Approach to Endoscopic Pituitary Adenoma Resection: A Randomized, Single-blind Trial

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Change in Quality of Life [ Time Frame: Pre-operative and Post-operative (2 weeks, 6 weeks, 3 months and 6 months) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in Symptom Score [ Time Frame: Pre-operative and Post-operative (2 weeks, 6 weeks, 3 months and 6 months) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    To determine the change in olfaction between the two groups at 6 months using the Smell Identification Test (SIT).


Estimated Enrollment: 55
Study Start Date: September 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01689064

Contacts
Contact: Luke Rudmik, MD 403-837-5853 lukerudmik@gmail.com
Contact: Kristine Smith, MD 587-228-3391 kasmi@ucalgary.ca

Locations
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada
Contact: Luke Rudmik, MD       lukerudmik@gmail.com   
Contact: Kristine Smith, MD    587-228-3391    kasmi@ucalgary.ca   
Principal Investigator: Luke Rudmik, MD         
Principal Investigator: Brad Mechor, MD         
Sub-Investigator: Kristine Smith, MD         
Sub-Investigator: Fiona Costello, MD         
Sub-Investigator: Alim Mitha, MD,MSc         
Sub-Investigator: Yves Starreveld, MD, PhD         
Sponsors and Collaborators
University of Calgary
Investigators
Principal Investigator: Luke Rudmik, MD University of Calgary
  More Information

Publications:
Responsible Party: Dr. Luke Rudmik, Principal Investigator, University of Calgary
ClinicalTrials.gov Identifier: NCT01689064     History of Changes
Other Study ID Numbers: E-24588
Study First Received: September 17, 2012
Last Updated: September 17, 2012
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Pituitary Neoplasms
Adenoma
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
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hypothalamic Diseases
Pituitary Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 24, 2014