Endocrine Outcome of Surgery for Pituitary Adenoma

Pituitary Adenoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03515603
• Other study ID #: EndOSPA
• Status: Terminated
• Phase: N/A
• Start date: May 10, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2023
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms

Intervention

Procedure:
• Endoscopic resection
Transsphenoidal endoscopic resection of pituitary adenoma
• Microsurgical resection
Transsphenoidal microsurgical resection of pituitary adenoma

Locations

Country	Name	City	State
Germany	Department of Neurosurgery	Günzburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endocrine function	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.	1 year after surgery
Secondary	Extent of resection	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	tumor volume before the surgery, 3 months after surgery
Secondary	Quality of Life, EQ-5D	EQ-5D will be evaluated before surgery, after the surgery in 3 months and after 1 year.	3 months and 1 year after surgery