Rhinological Outcomes in Endonasal Pituitary Surgery

Rhinological Outcomes in Endonasal Pituitary Surgery: A Multi-Center Observational Cohort Study

This is a prospective, multi-center observational study designed to address patient-reported nasal outcomes in adults undergoing endoscopic and microscopic surgical removal of pituitary tumors. The primary objective of this study is to determine the difference in nasal outcomes by using the Anterior Skull Base (ASK) Nasal survey between patients treated with endoscopic surgical technique and those treated with microscopic surgical technique. Patients will be given the ASK Nasal survey to assess their nasal functioning and overall health before their surgery, and at post-operative visits 1-2 weeks, 3 months, and 6 months.

Study Overview

• Status: Completed
• Conditions: Pituitary Adenoma; Acromegaly; Pituitary Neoplasm; Cushings Disease; Prolactinoma

Detailed Description

The technical and patient factors that influence rhinological (nasal) outcomes following endonasal anterior skull base surgery and pituitary surgery are not well understood. Several timely and controversial topics, such as the influence of endoscopic techniques and the impact of underlying disease on nasal outcomes are in need of further study.

The Anterior Skull Base (ASK) Nasal survey is a 24-item questionnaire designed to assess for common postoperative nasal complaints, such as crusting, nasal congestion, pain, sinusitis, sense of smell, and overall functioning. The survey is a brief and simple assessment that asks patients to score symptom severity on a five-point scale.

• Study Type: Observational
• Enrollment (Actual): 235

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Barrow Neurological Institute/St. Joseph's Hospital and Medical Center
  • California
    • Santa Monica, California, United States, 90404
      • John Wayne Cancer Institute at St. John's Health Center
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Northshore University Health System
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with pituitary lesions referred to our investigators for surgical management by either microscopic or endoscopic transspenoidal surgical resection.

Description

Inclusion Criteria:

• Pituitary tumor patients treated by transsphenoidal route
• Adults (age 18-80 years)
• Direct endonasal or endoscopic approach
• Non-functioning adenoma, Cushing's disease, acromegaly

Exclusion Criteria:

• Patients treated by expanded endonasal approaches (transtubercular approach)
• Sublabial approach

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Microscopic: Microscopic (single nostril, direct endonasal with nasal speculum)transsphenoidal nasal surgery
Endoscopic; Fully endoscopic: (bi-nostril, no nasal speculum) transsphenoidal pituitary surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ASK Nasal symptom severity scores and SF-8 scores	Compare symptom severity scores and quality of life scores in first-time surgery patients with nonfunctioning adenomas on the ASK Nasal and SF-8.	3 months
Validation of ASK Nasal survey tool	Validate a nasal outcomes scale (ASK Nasal) specifically designed for anterior skull base surgery.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ASK Nasal symptom severity scores	Evaluate the symptom severity scores on the ASK Nasal for first time surgery patients with nonfuctioning adenomas at the first post-operative visit and at 6 months.; Evaluate the symptom severity scores on the ASK Nasal for all patients at the first post-operative visit and at 6 months.	2 weeks, 3 months, 6 months postoperative
Impact of surgical techniques and complications on ASK Nasal scores	Subgroup analysis on the impact of such surgical techniques, such as middle turbinate resection and nasal packing, on ASK Nasal scores will be performed.; Subgroup analysis of rhinological complications, such as sinusitis, on ASK Nasal scores.; Objective intranasal endoscopy findings at follow-up visits.	6 months

Collaborators and Investigators

• Sponsor: St. Joseph's Hospital and Medical Center, Phoenix
• Investigators: Principal Investigator: Andrew S. Little, MD, Barrow Neurological Institute at St. Joseph's Hospital and Medical Center

Publications and helpful links

General Publications

• Little AS, Jahnke H, Nakaji P, Milligan J, Chapple K, White WL. The anterior skull base nasal inventory (ASK nasal inventory): a clinical tool for evaluating rhinological outcomes after endonasal surgery for pituitary and cranial base lesions. Pituitary. 2012 Dec;15(4):513-7. doi: 10.1007/s11102-011-0358-4.
• Zaidi HA, Awad AW, Bohl MA, Chapple K, Knecht L, Jahnke H, White WL, Little AS. Comparison of outcomes between a less experienced surgeon using a fully endoscopic technique and a very experienced surgeon using a microscopic transsphenoidal technique for pituitary adenoma. J Neurosurg. 2016 Mar;124(3):596-604. doi: 10.3171/2015.4.JNS15102. Epub 2015 Oct 16.
• Little AS, Kelly DF, Milligan J, Griffiths C, Prevedello DM, Carrau RL, Rosseau G, Barkhoudarian G, Jahnke H, Chaloner C, Jelinek KL, Chapple K, White WL. Comparison of sinonasal quality of life and health status in patients undergoing microscopic and endoscopic transsphenoidal surgery for pituitary lesions: a prospective cohort study. J Neurosurg. 2015 Sep;123(3):799-807. doi: 10.3171/2014.10.JNS14921. Epub 2015 Apr 17.
• Little AS, Kelly D, Milligan J, Griffiths C, Prevedello DM, Carrau RL, Rosseau G, Barkhoudarian G, Otto BA, Jahnke H, Chaloner C, Jelinek KL, Chapple K, White WL. Predictors of sinonasal quality of life and nasal morbidity after fully endoscopic transsphenoidal surgery. J Neurosurg. 2015 Jun;122(6):1458-65. doi: 10.3171/2014.10.JNS141624. Epub 2015 Apr 3.
• Little AS, Kelly D, Milligan J, Griffiths C, Rosseau G, Prevedello DM, Carrau R, Jahnke H, Chaloner C, O'Leary J, Chapple K, Nakaji P, White WL. Prospective validation of a patient-reported nasal quality-of-life tool for endonasal skull base surgery: The Anterior Skull Base Nasal Inventory-12. J Neurosurg. 2013 Oct;119(4):1068-74. doi: 10.3171/2013.3.JNS122032. Epub 2013 May 10.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2011
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): December 9, 2015

Study Registration Dates

• First Submitted: January 3, 2012
• First Submitted That Met QC Criteria: January 3, 2012
• First Posted (Estimate): January 5, 2012

Study Record Updates

• Last Update Posted (Actual): August 22, 2018
• Last Update Submitted That Met QC Criteria: August 21, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Endoscopic surgery; Transsphenoidal surgery; Pituitary surgery; Patient survey; Anterior skull base surgery; Nasal complications
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Musculoskeletal Diseases; Hypothalamic Diseases; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Bone Diseases; Bone Diseases, Endocrine; Hyperpituitarism; Adenoma; Pituitary Neoplasms; Pituitary Diseases; Acromegaly; ACTH-Secreting Pituitary Adenoma; Pituitary ACTH Hypersecretion; Prolactinoma
• Other Study ID Numbers: 11BN093