Electrophysiology of the Human Pituitary Gland

Study Overview
=================
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.

Official Title
-----------------
Identification of the Posterior Lobe of the Human Pituitary Gland During Surgery Using Its Electrophysiological, Neural Signature

Conditions
-----------------
Pituitary Adenoma, Pituitary Tumor, Diabetes Insipidus Cranial Type, Endocrine; Deficiency

Intervention / Treatment
-----------------
* Procedure: Micro-electrode measurement


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Pilot proof-of-concept study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Patients undergoing the extra intra-operative electrophysiological measurement | Procedure: Micro-electrode measurement<br>* Electrophysiological measurement with single-unit micro-electrode<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrophysiological properties | Electrophysiological properties of the human pituitary gland | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endocrine remission | Occurrence of endocrine remission after surgery | 6 months postoperative | 
| Endocrine deficiencies | Occurrence of endocrine deficiencies after surgery | 6 months postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Electrophysiology