Utilization of iMRI for Transsphenoidal Resection of Pituitary Macroadenomas

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02396810

Enrollment

Registered

2015-03-24

Start date

2015-05-19

Completion date

2023-07-01

Last updated

2023-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pituitary Macroadenoma

Brief summary

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.

Interventions

OTHERintra-operative MRI

Intra-operative magnetic resonance imaging under general anesthesia

PROCEDURETranssphenoidal resection of pituitary macroadenoma

Routine transsphenoidal resection of pituitary macro adenomas

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Adults 18-90 * Capable of giving informed consent * Elect for transsphenoidal surgery * Has pre-operative MRI demonstrating pituitary tumor that is: 1. deemed resectable using a transsphenoidal approach and 2. 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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026