Endocrine Outcome of Surgery for Pituitary Adenoma

Not Applicable

Terminated

• Conditions: Pituitary Adenoma
• Interventions: Procedure: Endoscopic resection; Procedure: Microsurgical resection

• Registration Number: NCT03515603
• Lead Sponsor: University of Ulm

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.

Study Timeline

• Study First Submitted: 2018-04-14
• Study First Submitted QC: 2018-05-02
• Study First Posted: 2018-05-03
• Study Start: 2018-05-10
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-14
• Last Update Posted: 2023-05-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
endoscopic technique	Endoscopic resection	-
microsurgical technique	Microsurgical resection	-

Primary Outcome Measures

Name	Time	Method
endocrine function	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.

Secondary Outcome Measures

Name	Time	Method
Extent of resection	tumor volume before the surgery, 3 months after surgery	Volumetric analysis of tumor volume before the surgery, intraoperatively and 3 months after surgery will be performed. Gross total resection is defined as no tumor present in gadolinium enhanced T1 sequences
Quality of Life, EQ-5D	3 months and 1 year after surgery	EQ-5D will be evaluated before surgery, after the surgery in 3 months and after 1 year.

Trial Locations

Locations (1)

Department of Neurosurgery; 🇩🇪 Günzburg, Germany