Electrophysiology of the Human Pituitary Gland

Not Applicable

Terminated

• Conditions: Pituitary Adenoma; Diabetes Insipidus Cranial Type; Endocrine; Deficiency; Pituitary Tumor
• Interventions: Procedure: Micro-electrode measurement

• Registration Number: NCT05338125
• Lead Sponsor: Leiden University Medical Center

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.

Study Timeline

• Study Start: 2020-12-10
• Study First Submitted: 2021-11-03
• Study First Submitted QC: 2022-04-13
• Study First Posted: 2022-04-20
• Status Verified: 2023-03
• Primary Completion: 2023-03-09
• Study Completion: 2023-03-09
• Last Update Submitted: 2023-03-09
• Last Update Posted: 2023-03-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention arm	Micro-electrode measurement	Patients undergoing the extra intra-operative electrophysiological measurement

Primary Outcome Measures

Name	Time	Method
Electrophysiological properties	Day 0	Electrophysiological properties of the human pituitary gland

Secondary Outcome Measures

Name	Time	Method
Endocrine remission	6 months postoperative	Occurrence of endocrine remission after surgery
Endocrine deficiencies	6 months postoperative	Occurrence of endocrine deficiencies after surgery

Trial Locations

Locations (1)

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands