- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03515603
Endocrine Outcome of Surgery for Pituitary Adenoma
May 14, 2023 updated by: Andrej Pala, University of Ulm
Compare Between Endoscopic and Microsurgical Transsphenoidal Resection of Pituitary Adenomas With Intraoperative MRI
Prospective and randomized compare between microsurgical and endoscopic transsphenoidal MRI assisted resection of pituitary adenomas.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Günzburg, Germany, 89312
- Department of Neurosurgery
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: microsurgical technique
|
Transsphenoidal microsurgical resection of pituitary adenoma
|
Active Comparator: endoscopic technique
|
Transsphenoidal endoscopic resection of pituitary adenoma
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Extent of resection
Time Frame: 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
|
tumor volume before the surgery, 3 months after surgery
|
Quality of Life, EQ-5D
Time Frame: 3 months and 1 year after surgery
|
EQ-5D will be evaluated before surgery, after the surgery in 3 months and after 1 year.
|
3 months and 1 year after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andrej Pala, MD, University Ulm, Department of Neurosurgery
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 10, 2018
Primary Completion (Actual)
December 31, 2022
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
April 14, 2018
First Submitted That Met QC Criteria
May 2, 2018
First Posted (Actual)
May 3, 2018
Study Record Updates
Last Update Posted (Actual)
May 17, 2023
Last Update Submitted That Met QC Criteria
May 14, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Hypothalamic Diseases
- Hypothalamic Neoplasms
- Supratentorial Neoplasms
- Brain Neoplasms
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Adenoma
- Pituitary Neoplasms
- Pituitary Diseases
Other Study ID Numbers
- EndOSPA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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