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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
Leiden University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pituitary Adenoma focused on measuring Electrophysiology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 3, 2021
Last Updated
March 9, 2023
Sponsor
Leiden University Medical Center
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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

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Electrophysiology of the Human Pituitary Gland

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