Compare Between Endoscopic and Microsurgical Transsphenoidal Resection of Pituitary Adenomas With Intraoperative MRI

University of Ulm1 site in 1 country36 target enrollmentMay 10, 2018

ConditionsPituitary Adenoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pituitary Adenoma
Sponsor: University of Ulm
Enrollment: 36
Locations: 1
Primary Endpoint: endocrine function
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Prospective and randomized compare between microsurgical and endoscopic transsphenoidal MRI assisted resection of pituitary adenomas.

Detailed Description

The main aim of the study is to compare microsurgical and endoscopic transsphenoidal surgery and to determine endocrine outcome. Secondary extent of resection and quality of life will be evaluated.

Registry

clinicaltrials.gov

Start Date

May 10, 2018

End Date

December 31, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Ulm

Responsible Party

Principal Investigator

Andrej Pala

Principal Investigator

University of Ulm

Eligibility Criteria

Inclusion Criteria

•Suspected symptomatic or progressively growing pituitary adenoma
•Informed consent

Exclusion Criteria

•Prolactinoma
•No follow-up possible
•Emergency surgery without informed consent or without intraoperative MRI

Outcomes

Primary Outcomes

endocrine function

Time Frame: 1 year after surgery

Testing of pituitary function with insulin-hypoglycemic test, results will be dichotomized as satisfactory or not satisfactory. Satisfactory outcome is defined, if pituitary function improves or is stable, if compared to preoperative testing.