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
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Adenoma
• Diabetes Insipidus
• Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms
• Pituitary Tumor

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