Utilization of iMRI for Transsphenoidal Resection of Pituitary Macroadenomas

Not Applicable

Terminated

• Conditions: Pituitary Macroadenoma
• Interventions: Other: intra-operative MRI; Procedure: Transsphenoidal resection of pituitary macroadenoma

• Registration Number: NCT02396810
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-05
• Study First Submitted QC: 2015-03-23
• Study First Posted: 2015-03-24
• Study Start: 2015-05-19
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intra-operative MRI	Transsphenoidal resection of pituitary macroadenoma	Patients undergo transspheonidal surgery followed by intra-operative MRI.
No intra-operative MRI	Transsphenoidal resection of pituitary macroadenoma	Patients undergo transsphenoidal surgery without an intra-operative MRI.
intra-operative MRI	intra-operative MRI	Patients undergo transspheonidal surgery followed by intra-operative MRI.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Frequency of post-operative CSF leak	30 days post surgery	Frequency of post-operative Cerebrospinal Fluid (CSF) leak
Operative time	intraoperative	Length of operation

Trial Locations

Locations (1)

Dartmouth Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States