Utilization of iMRI for Transsphenoidal Resection of Pituitary Macroadenomas

Pituitary Macroadenoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02396810
• Other study ID #: STUDY00028376 D14236
• Status: Terminated
• Phase: N/A
• Start date: May 19, 2015
• Est. completion date: July 1, 2023

Study information

• Verified date: August 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Pituitary Diseases
• Pituitary Macroadenoma

Intervention

Other:
• intra-operative MRI
Intra-operative magnetic resonance imaging under general anesthesia

Procedure:
• Transsphenoidal resection of pituitary macroadenoma
Routine transsphenoidal resection of pituitary macro adenomas

Locations

Country	Name	City	State
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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