Transsphenoidal Extent of Resection Study

Completed · Not applicable

Conditions studied: Pituitary Adenoma

In brief

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.

Key facts

Study ID

NCT02357498

Run by

St. Joseph's Hospital and Medical Center, Phoenix

People needed

260

Starts

2015-02-01

Expected to finish

2019-04-08

Last updated by the study team

2019-11-25

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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