Clinical trial · Interventional
Comparison of Surgical Approach to Endoscopic Pituitary Adenoma Resection
Comparison of the Posterior Septectomy and Stamm Approach to Endoscopic Pituitary Adenoma Resection: A Randomized, Single-blind Trial
NCT01689064CI-TRIAL-00016213completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pituitary Adenoma | Pituitary Neuroendocrine Tumor | ALIAS | 0.90 |
| Posterior Septectomy | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Stamm Approach | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Posterior Septectomy | Procedure | — | UNRESOLVED |
| Stamm Approach | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Posterior Septectomy
- description
- 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.
- interventionNames
- Procedure: Posterior Septectomy
- type
- EXPERIMENTAL
- label
- Stamm Approach
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (14)
- BACKGROUNDDaly AF, Rixhon M, Adam C, Dempegioti A, Tichomirowa MA, Beckers A. High prevalence of pituitary adenomas: a cross-sectional study in the province of Liege, Belgium. J Clin Endocrinol Metab. 2006 Dec;91(12):4769-75. doi: 10.1210/jc.2006-1668. Epub 2006 Sep 12. PMID 16968795
- BACKGROUNDHall WA, Luciano MG, Doppman JL, Patronas NJ, Oldfield EH. Pituitary magnetic resonance imaging in normal human volunteers: occult adenomas in the general population. Ann Intern Med. 1994 May 15;120(10):817-20. doi: 10.7326/0003-4819-120-10-199405150-00001. PMID 8154641
- BACKGROUNDFreda PU, Beckers AM, Katznelson L, Molitch ME, Montori VM, Post KD, Vance ML; Endocrine Society. Pituitary incidentaloma: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2011 Apr;96(4):894-904. doi: 10.1210/jc.2010-1048. PMID 21474686
- BACKGROUNDRotenberg B, Tam S, Ryu WH, Duggal N. Microscopic versus endoscopic pituitary surgery: a systematic review. Laryngoscope. 2010 Jul;120(7):1292-7. doi: 10.1002/lary.20949. PMID 20578228
- BACKGROUNDDeKlotz TR, Chia SH, Lu W, Makambi KH, Aulisi E, Deeb Z. Meta-analysis of endoscopic versus sublabial pituitary surgery. Laryngoscope. 2012 Mar;122(3):511-8. doi: 10.1002/lary.22479. Epub 2012 Jan 17. PMID 22252670
- BACKGROUNDOosmanally N, Paul JE, Zanation AM, Ewend MG, Senior BA, Ebert CS Jr. Comparative analysis of cost of endoscopic endonasal minimally invasive and sublabial-transseptal approaches to the pituitary. Int Forum Allergy Rhinol. 2011 Jul-Aug;1(4):242-9. doi: 10.1002/alr.20048. Epub 2011 Apr 28. PMID 22287427
- BACKGROUNDGraham SM, Iseli TA, Karnell LH, Clinger JD, Hitchon PW, Greenlee JD. Endoscopic approach for pituitary surgery improves rhinologic outcomes. Ann Otol Rhinol Laryngol. 2009 Sep;118(9):630-5. doi: 10.1177/000348940911800905.