Transsphenoidal Extent of Resection Study

NCT02357498 | Completed

• 1 other identifier: 14BN151
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 7

Brief 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. 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.

Conditions

Pituitary Adenoma

Keywords

pituitary; adenoma; transsphenoidal surgery

Outcome Measures

Primary Outcomes (1)

• percentage of patients who have complete tumor removal (gross total resection) based on MRI .

  Postop MRI read by neuroradiologist

  3 months post surgery

Secondary Outcomes (11)

• volume of residual tumor

  3 months after date of surgery

• percentage of tumor removed

  3 months post surgery

• postoperative cerebral-spinal fluid (CSF) leak

  6 months (continuous) from surgery

• postoperative meningitis

  6 months (continuous) from surgery

• hypopituitarism

  6 months post surgery

Study Arms (2)

microscopic

ACTIVE COMPARATOR

Microscopic transsphenoidal surgery, including endoscopic-assisted approach (350 subjects)

Procedure: transsphenoidal surgery

endoscopic

ACTIVE COMPARATOR

Fully endoscopic transsphenoidal surgery (350 subjects)

Procedure: transsphenoidal surgery

Interventions

transsphenoidal surgery PROCEDURE

endoscopic; microscopic

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Joseph's Hospital and Medical Center, Phoenix: lead
• Saint John's Cancer Institute: collaborator
• Swedish Medical Center: collaborator
• Northwestern University: collaborator
• Ohio State University: collaborator
• Washington University School of Medicine: collaborator
• University of Pittsburgh Medical Center: collaborator

Study Sites (7)

Barrow Neurological Institute/St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

John Wayne Cancer Institute

Santa Monica, California, 90404, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Swedish Neuroscience Institute

Seattle, Washington, 98122, United States

Location

Related Publications (26)

• 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.

  PMID: 4638402 BACKGROUND

• Hardy J. Transsphenoidal hypophysectomy. J Neurosurg. 1971 Apr;34(4):582-94. doi: 10.3171/jns.1971.34.4.0582. No abstract available.

  PMID: 5554367 BACKGROUND

• Fatemi 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.

  PMID: 18981830 BACKGROUND

• Patel 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.

  PMID: 22853837 BACKGROUND

• Dehdashti 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.

  PMID: 18580798 BACKGROUND

• Gondim 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.

  PMID: 19697135 BACKGROUND

• Cavallo 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.

  PMID: 19326977 BACKGROUND

• Cavallo 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.

  PMID: 17922153 BACKGROUND

• Jho 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.

  PMID: 11409304 BACKGROUND

• Jho 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.

  PMID: 9202264 BACKGROUND

• Ammirati 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.

  PMID: 23243265 BACKGROUND

• Starke 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.

  PMID: 23737543 BACKGROUND

• McLaughlin 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.

  PMID: 23240699 BACKGROUND

• Dallapiazza 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.

  PMID: 24995783 BACKGROUND

• 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.

  PMID: 23662829 BACKGROUND

• Gao Y, Zhong C, Wang Y, Xu S, Guo Y, Dai C, Zheng Y, Wang Y, Luo Q, Jiang J. Endoscopic versus microscopic transsphenoidal pituitary adenoma surgery: a meta-analysis. World J Surg Oncol. 2014 Apr 11;12:94. doi: 10.1186/1477-7819-12-94.

  PMID: 24721812 BACKGROUND

• Goudakos JK, Markou KD, Georgalas C. Endoscopic versus microscopic trans-sphenoidal pituitary surgery: a systematic review and meta-analysis. Clin Otolaryngol. 2011 Jun;36(3):212-20. doi: 10.1111/j.1749-4486.2011.02331.x.

  PMID: 21752205 BACKGROUND

• Rudmik L, Starreveld YP, Vandergrift WA, Banglawala SM, Soler ZM. Cost-effectiveness of the endoscopic versus microscopic approach for pituitary adenoma resection. Laryngoscope. 2015 Jan;125(1):16-24. doi: 10.1002/lary.24780. Epub 2014 Jun 17.

  PMID: 24938934 BACKGROUND

• Tabaee A, Anand VK, Barron Y, Hiltzik DH, Brown SM, Kacker A, Mazumdar M, Schwartz TH. Endoscopic pituitary surgery: a systematic review and meta-analysis. J Neurosurg. 2009 Sep;111(3):545-54. doi: 10.3171/2007.12.17635.

  PMID: 19199461 BACKGROUND

• Zhu M, Yang J, Wang Y, Cao W, Zhu Y, Qiu L, Tao Y, Xu Y, Xu H. [Endoscopic transsphenoidal surgery versus microsurgery for the resection of pituitary adenomas: a systematic review]. Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2014 Mar;49(3):236-9. Chinese.

  PMID: 24820497 BACKGROUND

• Komotar RJ, Starke RM, Raper DM, Anand VK, Schwartz TH. Endoscopic endonasal compared with microscopic transsphenoidal and open transcranial resection of craniopharyngiomas. World Neurosurg. 2012 Feb;77(2):329-41. doi: 10.1016/j.wneu.2011.07.011. Epub 2011 Nov 1.

  PMID: 22501020 BACKGROUND

• Little AS, Gardner PA, Fernandez-Miranda JC, Chicoine MR, Barkhoudarian G, Prevedello DM, Yuen KCJ, Kelly DF; TRANSSPHER Study Group. Pituitary gland recovery following fully endoscopic transsphenoidal surgery for nonfunctioning pituitary adenoma: results of a prospective multicenter study. J Neurosurg. 2019 Nov 15;133(6):1732-1738. doi: 10.3171/2019.8.JNS191012. Print 2020 Dec 1.

  PMID: 31731279 RESULT

• Little AS, Chicoine MR, Kelly DF, Sarris CE, Mooney MA, White WL, Gardner PA, Fernandez-Miranda JC, Barkhoudarian G, Chandler JP, Prevedello DM, Liebelt BD, Sfondouris J, Mayberg MR; TRANSSPHER Study Group. Evaluation of Surgical Resection Goal and Its Relationship to Extent of Resection and Patient Outcomes in a Multicenter Prospective Study of Patients With Surgically Treated, Nonfunctioning Pituitary Adenomas: A Case Series. Oper Neurosurg. 2020 Jan 1;18(1):26-33. doi: 10.1093/ons/opz085.

  PMID: 31079156 RESULT

• Little AS, Kelly DF, White WL, Gardner PA, Fernandez-Miranda JC, Chicoine MR, Barkhoudarian G, Chandler JP, Prevedello DM, Liebelt BD, Sfondouris J, Mayberg MR; TRANSSPHER Study Group. Results of a prospective multicenter controlled study comparing surgical outcomes of microscopic versus fully endoscopic transsphenoidal surgery for nonfunctioning pituitary adenomas: the Transsphenoidal Extent of Resection (TRANSSPHER) Study. J Neurosurg. 2019 Mar 22;132(4):1043-1053. doi: 10.3171/2018.11.JNS181238. Print 2020 Apr 1.

  PMID: 30901746 RESULT

• Mooney MA, Sarris CE, Zhou JJ, Barkhoudarian G, Chicoine MR, Fernandez-Miranda JC, Gardner PA, Hardesty DA, Jahnke H, Kelly DF, Liebelt BD, Mayberg MR, Prevedello DM, Sfondouris J, Sheehy JP, Chandler JP, Yuen KCJ, White WL, Little AS; TRANSSPHER Study Group. Proposal and Validation of a Simple Grading Scale (TRANSSPHER Grade) for Predicting Gross Total Resection of Nonfunctioning Pituitary Macroadenomas After Transsphenoidal Surgery. Oper Neurosurg. 2019 Nov 1;17(5):460-469. doi: 10.1093/ons/opy401.

  PMID: 30649445 RESULT

• Mooney MA, Herro AM, Fintelmann RE, Mayberg MR, Barkhoudarian G, Gardner PA, Prevedello DM, Chicoine MR, Kelly DF, Chandler JP, Jahnke H, White WL, Little AS. Visual Field Outcome Reporting in Neurosurgery: Lessons Learned from a Prospective, Multicenter Study of Transsphenoidal Pituitary Surgery. World Neurosurg. 2018 Dec;120:e326-e332. doi: 10.1016/j.wneu.2018.08.069. Epub 2018 Aug 23.

  PMID: 30144606 RESULT

MeSH Terms

Conditions

Pituitary Neoplasms; Pituitary Diseases; Adenoma

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Endocrine System Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Andrew Little, MD

  Saint Joseph's Hospital and Medical Center/Barrow Neurological Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Operations Manager

Study Record Dates

• First Submitted: January 26, 2015
• First Posted: February 6, 2015
• Study Start: February 1, 2015
• Primary Completion: February 1, 2019
• Study Completion: April 8, 2019
• Last Updated: November 25, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)