Utilization of iMRI for Transsphenoidal Resection of Pituitary Macroadenomas

Study Overview
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Brief Summary
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The investigators are studying the utility of intra-operative magnetic resonance imaging (iMRI) during transsphenoidal pituitary surgery for large macroadenomas by randomizing patients to either an intra-operative MRI after resection, or no intra-operative MRI. The investigators will then count the number of gross total resection in each group of patients and also the complications related to surgery.

Official Title
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A Single-center, Prospective, Randomized Controlled Trial Investigating the Utility if Intraoperative MRI in Transphenoidal Pituitary Surgery Off Macroadenomas.

Conditions
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Pituitary Macroadenoma

Intervention / Treatment
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* Other: intra-operative MRI
* Procedure: Transsphenoidal resection of pituitary macroadenoma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 18-90 Capable of giving informed consent Elect for transsphenoidal surgery Has pre-operative MRI demonstrating pituitary tumor that is: deemed resectable using a transsphenoidal approach and has a maximal diameter equal to or greater than 15 mm. No contraindications for MRI. Exclusion Criteria: Children (age < 18) Not able to give consent No pituitary tumor visible on MRI or an adenoma measuring less than 15mm in maximal dimension. Unable to tolerate MRI

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: No intra-operative MRI<br>Patients undergo transsphenoidal surgery without an intra-operative MRI. | Procedure: Transsphenoidal resection of pituitary macroadenoma<br>* Routine transsphenoidal resection of pituitary macro adenomas<br>|
| Experimental: intra-operative MRI<br>Patients undergo transspheonidal surgery followed by intra-operative MRI. | Other: intra-operative MRI<br>* Intra-operative magnetic resonance imaging under general anesthesia<br>Procedure: Transsphenoidal resection of pituitary macroadenoma<br>* Routine transsphenoidal resection of pituitary macro adenomas<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of gross total or maximal resection | Determine whether use of iMRI in transsphenoidal pituitary surgery for pituitary macroadenomas significantly increases the rate of maximal resection | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | Length of operation | intraoperative | 
| Frequency of post-operative CSF leak | Frequency of post-operative Cerebrospinal Fluid (CSF) leak | 30 days post surgery | 
| Rate of Readmission | Frequency of readmission | 30 days post surgery | 
| Length of anesthesia time | Length of time participant is under anesthesia | intraoperative | 
| Rate of post-operative endocrinopathies | Rate of post-operative endocrinopathies | 30 days post surgery |