Pituitary NeoplasmNCT01504399
Rhinological Outcomes in Endonasal Pituitary Surgery
An observational study of Pituitary Neoplasm and Pituitary Adenoma, run by St. Joseph's Hospital and Medical Center, Phoenix at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pituitary Neoplasm, Pituitary Adenoma, Prolactinoma
- How many people
- 235 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Oct 2011to 9 Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pituitary lesions referred to our investigators for surgical management by either microscopic or endoscopic transspenoidal surgical resection.
Who may be able to join
- Pituitary tumor patients treated by transsphenoidal route
- Adults (age 18-80 years)
- Direct endonasal or endoscopic approach
- Non-functioning adenoma, Cushing's disease, acromegaly
Who cannot join
- Patients treated by expanded endonasal approaches (transtubercular approach)
- Sublabial approach
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Northshore University Health System
Chicago, Illinois, 60640
Ohio State University Medical Center
Columbus, Ohio, 43210
Barrow Neurological Institute/St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
John Wayne Cancer Institute at St. John's Health Center
Santa Monica, California, 90404
About this study
Official title: 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.
Read the 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.
- Keywords
- Pituitary surgery, Transsphenoidal surgery, Anterior skull base surgery, Endoscopic surgery, Patient survey, Nasal complications
- Medical subject headings
- Pituitary Neoplasms, Prolactinoma, Adrenocortical Hyperfunction, Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Validation of ASK Nasal survey tool
Validate a nasal outcomes scale (ASK Nasal) specifically designed for anterior skull base surgery.
Measured: 3 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2012 (estimated)
- Study start1 Oct 2011
- Primary completion1 Jun 2014
- Study completion9 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pituitary NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew S. Little, MD, Principal investigator, Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01504399
- Sponsor's protocol ID
- 11BN093
- Status last verified
- Aug 2018
- First submitted
- 3 Jan 2012
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 22038032Zaidi 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.
PubMed 26473774Little 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.
PubMed 25884256Little 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.
PubMed 25839931Little 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.
PubMed 23662829
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rhinological Outcomes in Endonasal Pituitary Surgery: A Multi-Center Observational Cohort Study
- ClinicalTrials.gov ID
- NCT01504399
- Acronym / sponsor ID
- 11BN093
- Keywords
- Pituitary surgery, Transsphenoidal surgery, Anterior skull base surgery, Endoscopic surgery, Patient survey, Nasal complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- St. Joseph's Hospital and Medical Center, PhoenixUniversity, hospital or other
- Study start
- 1 Oct 2011 (actual)
- Primary completion
- 1 Jun 2014 (actual)
- Study completion
- 9 Dec 2015 (actual)
- First posted
- 5 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microscopic: | – | –Microscopic (single nostril, direct endonasal with nasal speculum)transsphenoidal nasal surgery |
| Endoscopic | – | –Fully endoscopic: (bi-nostril, no nasal speculum) transsphenoidal pituitary surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pituitary lesions referred to our investigators for surgical management by either microscopic or endoscopic transspenoidal surgical resection.
Key inclusion criteria (4 listed)
- Pituitary tumor patients treated by transsphenoidal route
- Adults (age 18-80 years)
- Direct endonasal or endoscopic approach
- Non-functioning adenoma, Cushing's disease, acromegaly
Key exclusion criteria (2 listed)
- Patients treated by expanded endonasal approaches (transtubercular approach)
- Sublabial approach
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ASK Nasal symptom severity scores and SF-8 scores
Time frame: 3 months
Compare symptom severity scores and quality of life scores in first-time surgery patients with nonfunctioning adenomas on the ASK Nasal and SF-8.
Validation of ASK Nasal survey tool
Time frame: 3 months
Validate a nasal outcomes scale (ASK Nasal) specifically designed for anterior skull base surgery.
2 secondary outcomes
ASK Nasal symptom severity scores
Time frame: 2 weeks, 3 months, 6 months postoperative
Impact of surgical techniques and complications on ASK Nasal scores
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Background: PubMed 22038032Little 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.
- Derived from this study: PubMed 26473774Zaidi 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.
- Derived from this study: PubMed 25884256Little 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.
- Derived from this study: PubMed 25839931Little 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.
- Derived from this study: PubMed 23662829Little 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew S. Little, MD principal investigator
Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pituitary Neoplasm and Pituitary Adenoma, run by St. Joseph's Hospital and Medical Center, Phoenix at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASK Nasal symptom severity scores and SF-8 scores (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01504399, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.