Electrophysiology of the Human Pituitary Gland
Primary Purpose
Pituitary Adenoma, Pituitary Tumor, Diabetes Insipidus Cranial Type
Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Micro-electrode measurement
Sponsored by
About this trial
This is an interventional prevention trial for Pituitary Adenoma focused on measuring Electrophysiology
Eligibility Criteria
Inclusion Criteria:
- Male and female patients undergoing transsphenoidal surgery for pituitary adenoma.
- Identification of the posterior lobe on preoperative MRI. This is most common in patients with micro-adenomas or small macroadenomas.
- Age >18 years
Exclusion Criteria:
- Emergency surgery
- Cognitive impairments
- Pregnancy
- Pre-existing diabetes insipidus
Sites / Locations
- Leiden University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention arm
Arm Description
Patients undergoing the extra intra-operative electrophysiological measurement
Outcomes
Primary Outcome Measures
Electrophysiological properties
Electrophysiological properties of the human pituitary gland
Secondary Outcome Measures
Endocrine remission
Occurrence of endocrine remission after surgery
Endocrine deficiencies
Occurrence of endocrine deficiencies after surgery
Full Information
NCT ID
NCT05338125
First Posted
November 3, 2021
Last Updated
March 9, 2023
Sponsor
Leiden University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05338125
Brief Title
Electrophysiology of the Human Pituitary Gland
Official Title
Identification of the Posterior Lobe of the Human Pituitary Gland During Surgery Using Its Electrophysiological, Neural Signature
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
too busy for recruitment
Study Start Date
December 10, 2020 (Actual)
Primary Completion Date
March 9, 2023 (Actual)
Study Completion Date
March 9, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Leiden University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Measurment of electrophysiological properties of the human pituitary gland during removal of a pituitary adenoma. Assessment if these properties are sufficient for intra-operative identification of different tissues.
Detailed Description
In this study, patients undergoing a surgical resection of a pituitary adenoma as part of standard care will undergo an extra measurement of the electrophysiological properties of the pituitary gland. A single-unit microlectrode will be introduced and placed in the adenoma tissue, anterior piuitary lobe and posterior pituitary lobe. Apart from this measurement, no other interventions are performed and standard care will continue. Six months after measurements the patients chart will be assessed for the occurrence of remission and endocrine deficiencies.
An assessment will be made if these properties are distinctive enough to allow intra-operative identification of the different tissues and thereby increase chances of maximal tumour removal and decrease chance of endocrine deficiencies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pituitary Adenoma, Pituitary Tumor, Diabetes Insipidus Cranial Type, Endocrine; Deficiency
Keywords
Electrophysiology
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pilot proof-of-concept study
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Patients undergoing the extra intra-operative electrophysiological measurement
Intervention Type
Procedure
Intervention Name(s)
Micro-electrode measurement
Intervention Description
Electrophysiological measurement with single-unit micro-electrode
Primary Outcome Measure Information:
Title
Electrophysiological properties
Description
Electrophysiological properties of the human pituitary gland
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Endocrine remission
Description
Occurrence of endocrine remission after surgery
Time Frame
6 months postoperative
Title
Endocrine deficiencies
Description
Occurrence of endocrine deficiencies after surgery
Time Frame
6 months postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female patients undergoing transsphenoidal surgery for pituitary adenoma.
Identification of the posterior lobe on preoperative MRI. This is most common in patients with micro-adenomas or small macroadenomas.
Age >18 years
Exclusion Criteria:
Emergency surgery
Cognitive impairments
Pregnancy
Pre-existing diabetes insipidus
Facility Information:
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2333ZA
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Electrophysiology of the Human Pituitary Gland
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