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NCT05338125 Clinical Trial

Electrophysiology of the Human Pituitary Gland

Pituitary Adenoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT05338125
Other study ID # P19.032
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date December 10, 2020
Est. completion date March 9, 2023

Study information
Verified date March 2023
Source Leiden University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 1
Est. completion date March 9, 2023
Est. primary completion date March 9, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Micro-electrode measurement
Electrophysiological measurement with single-unit micro-electrode

Locations
Country Name City State
Netherlands Leiden University Medical Center Leiden

Sponsors (1)
Lead Sponsor Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Electrophysiological properties Electrophysiological properties of the human pituitary gland Day 0
Secondary Endocrine remission Occurrence of endocrine remission after surgery 6 months postoperative
Secondary Endocrine deficiencies Occurrence of endocrine deficiencies after surgery 6 months postoperative
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