Back to resultsEndocrine Outcome of Surgery for Pituitary Adenoma
Primary Purpose
Pituitary Adenoma
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Endoscopic resection
Microsurgical resection
Sponsored by
About this trial
This is an interventional treatment trial for Pituitary Adenoma
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
Sites / Locations
- Department of Neurosurgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
microsurgical technique
endoscopic technique
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Quality of Life, EQ-5D
EQ-5D will be evaluated before surgery, after the surgery in 3 months and after 1 year.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03515603
Brief Title
Endocrine Outcome of Surgery for Pituitary Adenoma
Official Title
Compare Between Endoscopic and Microsurgical Transsphenoidal Resection of Pituitary Adenomas With Intraoperative MRI
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Inadequate recruiting
Study Start Date
May 10, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ulm
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pituitary Adenoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective randomized
Masking
ParticipantCare Provider
Masking Description
only surgeon knows the used technique, endocrinologist, patient and all involved medical staff is blinded
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
microsurgical technique
Arm Type
Active Comparator
Arm Title
endoscopic technique
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Endoscopic resection
Intervention Description
Transsphenoidal endoscopic resection of pituitary adenoma
Intervention Type
Procedure
Intervention Name(s)
Microsurgical resection
Intervention Description
Transsphenoidal microsurgical resection of pituitary adenoma
Primary Outcome Measure Information:
Title
endocrine function
Description
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.
Time Frame
1 year after surgery
Secondary Outcome Measure Information:
Title
Extent of resection
Description
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
Time Frame
tumor volume before the surgery, 3 months after surgery
Title
Quality of Life, EQ-5D
Description
EQ-5D will be evaluated before surgery, after the surgery in 3 months and after 1 year.
Time Frame
3 months and 1 year after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrej Pala, MD
Organizational Affiliation
University Ulm, Department of Neurosurgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurosurgery
City
Günzburg
ZIP/Postal Code
89312
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Endocrine Outcome of Surgery for Pituitary Adenoma
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