Electrophysiology of the Human Pituitary Gland

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-10

Study Completion Date

2023-03-09

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pituitary Adenoma Pituitary Tumor Diabetes Insipidus Cranial Type Endocrine; Deficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pilot proof-of-concept study

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention arm

Patients undergoing the extra intra-operative electrophysiological measurement

Group Type EXPERIMENTAL

Micro-electrode measurement

Intervention Type PROCEDURE

Electrophysiological measurement with single-unit micro-electrode

Interventions

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Micro-electrode measurement

Electrophysiological measurement with single-unit micro-electrode

Intervention Type PROCEDURE

Eligibility Criteria

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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