Electrophysiology of the Human Pituitary Gland

March 9, 2023 updated by: wrvanfurth, Leiden University Medical Center

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1

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

  • Netherlands
      • Leiden, Netherlands, 2333ZA
        • Leiden University Medical Center

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

Genders Eligible for Study

All

Description

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

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leiden University Medical Center

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)

December 10, 2020

Primary Completion (Actual)

March 9, 2023

Study Completion (Actual)

March 9, 2023

Study Registration Dates

First Submitted

November 3, 2021

First Submitted That Met QC Criteria

April 13, 2022

First Posted (Actual)

April 20, 2022

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P19.032

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

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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