Pituitary AdenomaTRANSSPHERNCT02357498
Transsphenoidal Extent of Resection Study
A study testing transsphenoidal surgery in people with Pituitary Adenoma, run by St. Joseph's Hospital and Medical Center, Phoenix at 7 sites in United States.
Trial summary
The purpose of this research study is to compare the extent of resection (EOR) in patients with nonfunctioning pituitary adenomas undergoing transsphenoidal surgery using a microsurgical technique to those patients who have undergone surgery with a fully endoscopic technique. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pituitary Adenoma
- What is being tested?
- transsphenoidal surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Feb 2015to 8 Apr 2019
- Phase
- Interventional
- 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
Who may be able to join
- Patients with suspected nonfunctioning pituitary macroadenomas (≥ 1 cm) with planned transsphenoidal surgery
- Adults (age 18-80 years)
- Medically stable for surgery
- Reasonable expectation that patient will complete study and be available for follow-up assessments
Who cannot join
- Prisoners
- Pregnant women
- Patients with suspected functioning pituitary adenoma
- Unable to obtain MRI of the pituitary (e.g., pacemaker, anaphylaxis to gadolinium, low GFR)
- Pituitary apoplexy
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Northwestern University
Chicago, Illinois, 60611
Ohio State University Medical Center
Columbus, Ohio, 43210
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
Barrow Neurological Institute/St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
John Wayne Cancer Institute
Santa Monica, California, 90404
Swedish Neuroscience Institute
Seattle, Washington, 98122
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Prospective Multicenter Cohort Study Comparing Extent of Tumor Resection Between Microscopic Transsphenoidal Surgery and Fully Endoscopic Transsphenoidal Surgery for Nonfunctioning Pituitary Adenomas
The purpose of this research study is to compare the extent of resection (EOR) in patients with nonfunctioning pituitary adenomas undergoing transsphenoidal surgery using a microsurgical technique to those patients who have undergone surgery with a fully endoscopic technique. Another goal is to compare surgical complications, endocrine outcomes, visual outcomes, length of surgery, length of hospital stay, and readmission rates between the two transsphenoidal surgery techniques. This is an observational data collection study with no experimental procedures or experimental medicines. Endonasal transsphenoidal removal of a pituitary tumor is a unique procedure and there is little information comparing the two surgical techniques.
Read the detailed description
The treatment of choice for most patients with symptomatic nonfunctioning pituitary adenomas is transsphenoidal surgery to improve vision by decompression of the optic chiasm, to prevent the development of endocrine dysfunction, and to treat neurological symptoms such as headache or cranial neuropathies caused by the tumor. The most widely accepted surgical technique is microscopic transsphenoidal surgery, in which an operating microscope is used by the surgeon to provide surgical visualization and a nasal speculum is used to maintain the operative corridor. [1-4] Recently, fully endoscopic transsphenoidal surgery, in which surgical visualization is achieved using an endoscope, has been adopted by many pituitary surgeons because the technique offers superior panoramic and angled visualization of the surgical target and may permit greater tumor resection. [5-10] There is a vigorous debate in the neurosurgical community about the relative merits of the microscopic and endoscopic techniques. Proponents of the endoscopic technique argue that the superior visualization permits more aggressive tumor resection and better preservation of the normal pituitary gland. Proponents of the microscopic technique argue that it permits shorter operative times, results in similar surgical outcomes, and has a lower complication rate.
Despite the adoption of fully endoscopic surgery by many surgeons, no prospective studies have compared the extent of tumor resection (EOR) between microscopic and endoscopic approaches. Numerous retrospective studies have established the efficacy of each approach, but only a few studies present comparative data.[11-13] Recently, McLaughlin et al. noted that the addition of endoscopy to microscopic pituitary surgery enhances tumor removal, particularly in patients with tumors greater than 20 mm in diameter. [14] This study raises the intriguing possibility that certain subgroups of patients (e.g. patients with larger tumors) may benefit from endoscopic surgery. In patients with smaller tumors with no cavernous sinus invasion, others have shown that the techniques achieve similar EOR. [15] That endoscopy may permit more complete tumor resections is a testable hypothesis.
- Conditions
- Pituitary Adenoma
- Being tested
- transsphenoidal surgery
- Keywords
- pituitary, adenoma, transsphenoidal surgery
- Medical subject headings
- Pituitary Neoplasms, Pituitary Diseases, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transsphenoidal surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| microscopic | Active comparator | Microscopic transsphenoidal surgery, including endoscopic-assisted approach (350 subjects) Receives: Procedure: transsphenoidal surgery |
| endoscopic | Active comparator | Fully endoscopic transsphenoidal surgery (350 subjects) Receives: Procedure: transsphenoidal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients who have complete tumor removal (gross total resection) based on MRI .
Postop MRI read by neuroradiologist
Measured: 3 months post surgery
Secondary outcomes (11)
volume of residual tumor
volume, analyzed as a continuous variable; will be determined by manual segmentation using Dominator (www.dominator.com) software under the supervision of a board-certified neuroradiologist
Measured: 3 months after date of surgery
percentage of tumor removed
Postop MRI tumor bed read by neuroradilogisy
Measured: 3 months post surgery
postoperative cerebral-spinal fluid (CSF) leak
leakage from nose is a known complication, however, patients who have undergone a second surgery or had a lumbar drain placed to repair the problem will be documented
Measured: 6 months (continuous) from surgery
postoperative meningitis
Determined by symptoms of headache, fever, neck stiffness, nausea and vomiting, and occasionally an altered level of consciousness. CSF culture may be positive for infection and may show elevated glucose and/or protein. CSF may be negative in aseptic meningitis.
Measured: 6 months (continuous) from surgery
hypopituitarism
(morning cortisol <4.0ug/dL)(adrenocorticotropic hormone ACTH <6.0pg/mL)(follicular stimulating hormone FSH - mIU/mL. Female: follicular: <3.5; midcycle <4.7; luteal <1.7; postmenopausal <25.8. male <1.7)(luteinizing hormone LH - mIU/mL. Female: follicular <2.4; midcycle <14.0; luteal <1.0; postmenopausal <7.7)(estradiol - pg/mL. female: follicular <13; ovulation <86; luteal <44; postmenopausal <56)(insulin-like growth factor 1 IGF1: 101ng/mL)(testosterone total - ng/dL. Female <6.0; male <270.0)(prolactin ,3.3ng/mL)(thyroid stimulating hormone TSH <.45mU/L)(Thyroxine T4 Free <0.8ng/dL
Measured: 6 months post surgery
diabetes insipidus (DI)
to be evaluated by pituitary endocrinologist; serum sodium value is > or equal to 147meq/dl OR if the patient received treatment for DI
Measured: 6 months post surgery
visual outcomes
visual field deficits in this exam will be compared to pre-operative results. Confrontation visual field exam (Donder's test): The examiner will ask the patient to cover one eye and stare at the examiner. The examiner will then move his hand out of the patient's visual field and bring it back in. The examiner will use a slowly wagging finger or a hat pin for this. The patient signals the examiner when his hand comes back into view. Second option is a formal visual field exam (perimetry) performed by a neuro-ophthalmologist.
Measured: 3 months post surgery
hypothyroidism
(thyroid stimulating hormone TSH <.45mU/L)(thyroxine T4Free <0.8ng/dL)
Measured: 6 months post surgery
hypogonadism
(Testosterone (Total) - ng/dL. Female: < 6.0; Male: < 270.0) (Follicular Stimulating Hormone (FSH) - mIU/mL. Female - Follicular: < 3.5; Midcycle: <4.7; Luteal: < 1.7; Postmenopausal: < 25.8. Male - < 1.5)(Luteinizing Hormone LH - mIU/mL. Female: Follicular: < 2.4; Midcycle: <14.0; Luteal: < 1.0; Postmenopausal: < 7.7. Male: < 1.7)(Estradiol - pg/mL. Female: Follicular: < 13; Ovulation: < 86; Luteal: < 44; Postmenopausal: < 56. Male: < 15)
Measured: 6 months post surgery
growth hormone deficiency
(insulin tolerance test: growth hormone <3μg/l)(IGF1 <77)(symptoms may include thin and dry skin, low energy, decreased strength and exercise tolerance, decreased muscle mass, weight gain especially around the waist, feelings of anxiety, depression, or sadness causing a change in social behavior
Measured: 6 months post surgery
adrenal insufficiency
(morning serum cortisol <4.0ug/dL)(ACTH <6.0pg/mL)(sodium <135mEq/L)(abnormal ACTH [cosyntropin] stimulation test)
Measured: 6 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study start1 Feb 2015
- Primary completion1 Feb 2019
- Study completion8 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Pituitary AdenomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
- Sponsor type
- University, hospital or other
- Collaborators
- Saint John's Cancer Institute, Swedish Medical Center, Northwestern University, Ohio State University, Washington University School of Medicine, University of Pittsburgh Medical Center
- Responsible party
- Principal investigator, Pam Dewey, St. Joseph's Hospital and Medical Center, Phoenix
- Investigators
- Andrew Little, MD, Principal investigator, Saint Joseph's Hospital and Medical Center/Barrow Neurological Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357498
- Sponsor's protocol ID
- 14BN151
- Acronym
- TRANSSPHER
- Status last verified
- Nov 2019
- First submitted
- 26 Jan 2015
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Wilson CB, Rand RW, Grollmus JM, Heuser G, Levin S, Goldfield E, Schneider V, Linfoot J, Hosobuchi Y. Surgical experience with a microscopic transsphenoidal approach to pituitary tumors and non-neoplastic parasellar conditions. Calif Med. 1972 Nov;117(5):1-9.
PubMed 4638402Hardy J. Transsphenoidal hypophysectomy. J Neurosurg. 1971 Apr;34(4):582-94. doi: 10.3171/jns.1971.34.4.0582. No abstract available.
PubMed 5554367Fatemi N, Dusick JR, de Paiva Neto MA, Kelly DF. The endonasal microscopic approach for pituitary adenomas and other parasellar tumors: a 10-year experience. Neurosurgery. 2008 Oct;63(4 Suppl 2):244-56; discussion 256. doi: 10.1227/01.NEU.0000327025.03975.BA.
PubMed 18981830Patel SK, Husain Q, Eloy JA, Couldwell WT, Liu JK. Norman Dott, Gerard Guiot, and Jules Hardy: key players in the resurrection and preservation of transsphenoidal surgery. Neurosurg Focus. 2012 Aug;33(2):E6. doi: 10.3171/2012.6.FOCUS12125.
PubMed 22853837Dehdashti AR, Ganna A, Karabatsou K, Gentili F. Pure endoscopic endonasal approach for pituitary adenomas: early surgical results in 200 patients and comparison with previous microsurgical series. Neurosurgery. 2008 May;62(5):1006-15; discussion 1015-7. doi: 10.1227/01.neu.0000325862.83961.12.
PubMed 18580798Gondim JA, Schops M, de Almeida JP, de Albuquerque LA, Gomes E, Ferraz T, Barroso FA. Endoscopic endonasal transsphenoidal surgery: surgical results of 228 pituitary adenomas treated in a pituitary center. Pituitary. 2010;13(1):68-77. doi: 10.1007/s11102-009-0195-x. Epub 2009 Aug 21.
PubMed 19697135Cavallo LM, Prevedello DM, Solari D, Gardner PA, Esposito F, Snyderman CH, Carrau RL, Kassam AB, Cappabianca P. Extended endoscopic endonasal transsphenoidal approach for residual or recurrent craniopharyngiomas. J Neurosurg. 2009 Sep;111(3):578-89. doi: 10.3171/2009.2.JNS081026.
PubMed 19326977Cavallo LM, Prevedello D, Esposito F, Laws ER Jr, Dusick JR, Messina A, Jane JA Jr, Kelly DF, Cappabianca P. The role of the endoscope in the transsphenoidal management of cystic lesions of the sellar region. Neurosurg Rev. 2008 Jan;31(1):55-64; discussion 64. doi: 10.1007/s10143-007-0098-0. Epub 2007 Oct 6.
PubMed 17922153Jho HD, Alfieri A. Endoscopic endonasal pituitary surgery: evolution of surgical technique and equipment in 150 operations. Minim Invasive Neurosurg. 2001 Mar;44(1):1-12. doi: 10.1055/s-2001-13590.
PubMed 11409304Jho HD, Carrau RL. Endoscopic endonasal transsphenoidal surgery: experience with 50 patients. J Neurosurg. 1997 Jul;87(1):44-51. doi: 10.3171/jns.1997.87.1.0044.
PubMed 9202264Ammirati M, Wei L, Ciric I. Short-term outcome of endoscopic versus microscopic pituitary adenoma surgery: a systematic review and meta-analysis. J Neurol Neurosurg Psychiatry. 2013 Aug;84(8):843-9. doi: 10.1136/jnnp-2012-303194. Epub 2012 Dec 15.
PubMed 23243265Starke RM, Raper DM, Payne SC, Vance ML, Oldfield EH, Jane JA Jr. Endoscopic vs microsurgical transsphenoidal surgery for acromegaly: outcomes in a concurrent series of patients using modern criteria for remission. J Clin Endocrinol Metab. 2013 Aug;98(8):3190-8. doi: 10.1210/jc.2013-1036. Epub 2013 Jun 4.
PubMed 23737543McLaughlin N, Eisenberg AA, Cohan P, Chaloner CB, Kelly DF. Value of endoscopy for maximizing tumor removal in endonasal transsphenoidal pituitary adenoma surgery. J Neurosurg. 2013 Mar;118(3):613-20. doi: 10.3171/2012.11.JNS112020. Epub 2012 Dec 14.
PubMed 23240699Dallapiazza R, Bond AE, Grober Y, Louis RG, Payne SC, Oldfield EH, Jane JA Jr. Retrospective analysis of a concurrent series of microscopic versus endoscopic transsphenoidal surgeries for Knosp Grades 0-2 nonfunctioning pituitary macroadenomas at a single institution. J Neurosurg. 2014 Sep;121(3):511-7. doi: 10.3171/2014.6.JNS131321. Epub 2014 Jul 4.
PubMed 24995783Little 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 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Cohort Study Comparing Extent of Tumor Resection Between Microscopic Transsphenoidal Surgery and Fully Endoscopic Transsphenoidal Surgery for Nonfunctioning Pituitary Adenomas
- ClinicalTrials.gov ID
- NCT02357498
- Acronym / sponsor ID
- TRANSSPHER / 14BN151
- Conditions
- Pituitary Adenoma
- Keywords
- pituitary, adenoma, transsphenoidal surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- St. Joseph's Hospital and Medical Center, PhoenixUniversity, hospital or other
- Collaborators
- Saint John's Cancer Institute, Swedish Medical Center, Northwestern University, Ohio State University, Washington University School of Medicine, University of Pittsburgh Medical Center
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 8 Apr 2019 (actual)
- First posted
- 6 Feb 2015 (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.
The purpose of this research study is to compare the extent of resection (EOR) in patients with nonfunctioning pituitary adenomas undergoing transsphenoidal surgery using a microsurgical technique to those patients who have undergone surgery with a fully endoscopic technique. Another goal is to compare surgical complications, endocrine outcomes, visual outcomes, length of surgery, length of hospital stay, and readmission rates between the two transsphenoidal surgery techniques. This is an observational data collection study with no experimental procedures or experimental medicines. Endonasal transsphenoidal removal of a pituitary tumor is a unique procedure and there is little information comparing the two surgical techniques.
Detailed description
The treatment of choice for most patients with symptomatic nonfunctioning pituitary adenomas is transsphenoidal surgery to improve vision by decompression of the optic chiasm, to prevent the development of endocrine dysfunction, and to treat neurological symptoms such as headache or cranial neuropathies caused by the tumor. The most widely accepted surgical technique is microscopic transsphenoidal surgery, in which an operating microscope is used by the surgeon to provide surgical visualization and a nasal speculum is used to maintain the operative corridor. [1-4] Recently, fully endoscopic transsphenoidal surgery, in which surgical visualization is achieved using an endoscope, has been adopted by many pituitary surgeons because the technique offers superior panoramic and angled visualization of the surgical target and may permit greater tumor resection. [5-10] There is a vigorous debate in the neurosurgical community about the relative merits of the microscopic and endoscopic techniques. Proponents of the endoscopic technique argue that the superior visualization permits more aggressive tumor resection and better preservation of the normal pituitary gland. Proponents of the microscopic technique argue that it permits shorter operative times, results in similar surgical outcomes, and has a lower complication rate.
Despite the adoption of fully endoscopic surgery by many surgeons, no prospective studies have compared the extent of tumor resection (EOR) between microscopic and endoscopic approaches. Numerous retrospective studies have established the efficacy of each approach, but only a few studies present comparative data.[11-13] Recently, McLaughlin et al. noted that the addition of endoscopy to microscopic pituitary surgery enhances tumor removal, particularly in patients with tumors greater than 20 mm in diameter. [14] This study raises the intriguing possibility that certain subgroups of patients (e.g. patients with larger tumors) may benefit from endoscopic surgery. In patients with smaller tumors with no cavernous sinus invasion, others have shown that the techniques achieve similar EOR. [15] That endoscopy may permit more complete tumor resections is a testable hypothesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| microscopic | Active comparator | Procedure: transsphenoidal surgeryMicroscopic transsphenoidal surgery, including endoscopic-assisted approach (350 subjects) |
| endoscopic | Active comparator | Procedure: transsphenoidal surgeryFully endoscopic transsphenoidal surgery (350 subjects) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with suspected nonfunctioning pituitary macroadenomas (≥ 1 cm) with planned transsphenoidal surgery
- Adults (age 18-80 years)
- Medically stable for surgery
- Reasonable expectation that patient will complete study and be available for follow-up assessments
Key exclusion criteria (5 listed)
- Prisoners
- Pregnant women
- Patients with suspected functioning pituitary adenoma
- Unable to obtain MRI of the pituitary (e.g., pacemaker, anaphylaxis to gadolinium, low GFR)
- Pituitary apoplexy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transsphenoidal surgery | Procedure or surgery | endoscopic, microscopic |
Primary outcome
percentage of patients who have complete tumor removal (gross total resection) based on MRI .
Time frame: 3 months post surgery
Postop MRI read by neuroradiologist
11 secondary outcomes
volume of residual tumor
Time frame: 3 months after date of surgery
percentage of tumor removed
Time frame: 3 months post surgery
postoperative cerebral-spinal fluid (CSF) leak
Time frame: 6 months (continuous) from surgery
postoperative meningitis
Time frame: 6 months (continuous) from surgery
hypopituitarism
Time frame: 6 months post surgery
diabetes insipidus (DI)
Time frame: 6 months post surgery
visual outcomes
Time frame: 3 months post surgery
hypothyroidism
Time frame: 6 months post surgery
hypogonadism
Time frame: 6 months post surgery
growth hormone deficiency
Time frame: 6 months post surgery
adrenal insufficiency
Time frame: 6 months post surgery
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 25 Nov 2019.
- Background: PubMed 4638402Wilson CB, Rand RW, Grollmus JM, Heuser G, Levin S, Goldfield E, Schneider V, Linfoot J, Hosobuchi Y. Surgical experience with a microscopic transsphenoidal approach to pituitary tumors and non-neoplastic parasellar conditions. Calif Med. 1972 Nov;117(5):1-9.
- Background: PubMed 5554367Hardy J. Transsphenoidal hypophysectomy. J Neurosurg. 1971 Apr;34(4):582-94. doi: 10.3171/jns.1971.34.4.0582. No abstract available.
- Background: PubMed 18981830Fatemi N, Dusick JR, de Paiva Neto MA, Kelly DF. The endonasal microscopic approach for pituitary adenomas and other parasellar tumors: a 10-year experience. Neurosurgery. 2008 Oct;63(4 Suppl 2):244-56; discussion 256. doi: 10.1227/01.NEU.0000327025.03975.BA.
- Background: PubMed 22853837Patel SK, Husain Q, Eloy JA, Couldwell WT, Liu JK. Norman Dott, Gerard Guiot, and Jules Hardy: key players in the resurrection and preservation of transsphenoidal surgery. Neurosurg Focus. 2012 Aug;33(2):E6. doi: 10.3171/2012.6.FOCUS12125.
- Background: PubMed 18580798Dehdashti AR, Ganna A, Karabatsou K, Gentili F. Pure endoscopic endonasal approach for pituitary adenomas: early surgical results in 200 patients and comparison with previous microsurgical series. Neurosurgery. 2008 May;62(5):1006-15; discussion 1015-7. doi: 10.1227/01.neu.0000325862.83961.12.
- Background: PubMed 19697135Gondim JA, Schops M, de Almeida JP, de Albuquerque LA, Gomes E, Ferraz T, Barroso FA. Endoscopic endonasal transsphenoidal surgery: surgical results of 228 pituitary adenomas treated in a pituitary center. Pituitary. 2010;13(1):68-77. doi: 10.1007/s11102-009-0195-x. Epub 2009 Aug 21.
- Background: PubMed 19326977Cavallo LM, Prevedello DM, Solari D, Gardner PA, Esposito F, Snyderman CH, Carrau RL, Kassam AB, Cappabianca P. Extended endoscopic endonasal transsphenoidal approach for residual or recurrent craniopharyngiomas. J Neurosurg. 2009 Sep;111(3):578-89. doi: 10.3171/2009.2.JNS081026.
- Background: PubMed 17922153Cavallo LM, Prevedello D, Esposito F, Laws ER Jr, Dusick JR, Messina A, Jane JA Jr, Kelly DF, Cappabianca P. The role of the endoscope in the transsphenoidal management of cystic lesions of the sellar region. Neurosurg Rev. 2008 Jan;31(1):55-64; discussion 64. doi: 10.1007/s10143-007-0098-0. Epub 2007 Oct 6.
- Background: PubMed 11409304Jho HD, Alfieri A. Endoscopic endonasal pituitary surgery: evolution of surgical technique and equipment in 150 operations. Minim Invasive Neurosurg. 2001 Mar;44(1):1-12. doi: 10.1055/s-2001-13590.
- Background: PubMed 9202264Jho HD, Carrau RL. Endoscopic endonasal transsphenoidal surgery: experience with 50 patients. J Neurosurg. 1997 Jul;87(1):44-51. doi: 10.3171/jns.1997.87.1.0044.
- Background: PubMed 23243265Ammirati M, Wei L, Ciric I. Short-term outcome of endoscopic versus microscopic pituitary adenoma surgery: a systematic review and meta-analysis. J Neurol Neurosurg Psychiatry. 2013 Aug;84(8):843-9. doi: 10.1136/jnnp-2012-303194. Epub 2012 Dec 15.
- Background: PubMed 23737543Starke RM, Raper DM, Payne SC, Vance ML, Oldfield EH, Jane JA Jr. Endoscopic vs microsurgical transsphenoidal surgery for acromegaly: outcomes in a concurrent series of patients using modern criteria for remission. J Clin Endocrinol Metab. 2013 Aug;98(8):3190-8. doi: 10.1210/jc.2013-1036. Epub 2013 Jun 4.
- Individual participant dataSharing planned: No
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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 Little, MD principal investigator
Saint Joseph's Hospital and Medical Center/Barrow Neurological Institute
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transsphenoidal surgery in people with Pituitary Adenoma, run by St. Joseph's Hospital and Medical Center, Phoenix at 7 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 5 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 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
percentage of patients who have complete tumor removal (gross total resection) based on MRI . (time frame: 3 months post surgery). 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 NCT02357498, which also lists 26 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 25 Nov 2019.