Transsphenoidal Extent of Resection Study

NCT ID: NCT02357498

Last Updated: 2019-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-01
• Study Completion Date: 2019-04-08

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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

microscopic

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

Group Type: ACTIVE_COMPARATOR

transsphenoidal surgery

Intervention Type: PROCEDURE

endoscopic

Fully endoscopic transsphenoidal surgery (350 subjects)

Group Type: ACTIVE_COMPARATOR

transsphenoidal surgery

Intervention Type: PROCEDURE

Interventions

transsphenoidal surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saint John's Cancer Institute

OTHER

Sponsor Role: collaborator

Swedish Medical Center

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

University of Pittsburgh Medical Center

OTHER

Sponsor Role: collaborator

St. Joseph's Hospital and Medical Center, Phoenix

OTHER

Sponsor Role: lead

Responsible Party

Pam Dewey

Clinical Research Operations Manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew Little, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Phoenix, Arizona, United States

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

John Wayne Cancer Institute

Santa Monica, California, United States

Northwestern University

Chicago, Illinois, United States

Washington University School of Medicine

St Louis, Missouri, United States

Ohio State University Medical Center

Columbus, Ohio, United States

Swedish Neuroscience Institute

Seattle, Washington, United States

Countries

United States

References

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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.

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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.

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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.

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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.

Reference Type: RESULT

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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.

Reference Type: RESULT

PMID: 30144606 (View on PubMed)

Other Identifiers

14BN151

Identifier Type: -

Identifier Source: org_study_id