Pituitary adenoma Cancer
Conditions
Interventions
Care follows the usual NHS pathway for endoscopic transsphenoidal surgery. During the operation, the surgeon may use the Panda handheld device alongside standard instruments to assist with precise tum
outcomes are assessed up to 6 months after surgery.
Sponsors
University College London
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Adult patient =18 years 2. Suspected pituitary adenoma defined on a dedicated contrast-enhanced pituitary MRI scan 3. Capacity to consent for research study 4. Able to meet the proposed primary study schedule including face-to-face clinic reviews
Exclusion criteria
Exclusion criteria: 1. Paediatric patients 2. Patients without capacity to consent for study 3. Patients undergoing transcranial surgery 4. Previous transsphenoidal surgery in previous 12 months 5. Radiological evidence of an alternative diagnosis (pituitary hypophysitis) 6. Patients with contraindications to undergo magnetic resonance imaging 7. Patients with contraindications to intravenous gadolinium contrast for imaging 8. Unmanaged chronic infection 9. Uncontrolled chronic health condition precluding safe anaesthesia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Feasibility, defined as successful intraoperative use of the Panda Surgical Handheld System during tumour removal and/or closure, as recorded in the surgical operation note and confirmed by independent blinded video review. Timepoint: Intraoperative (day of surgery). 2. Safety, incidence of device-related adverse events and device deficiencies, recorded via case report forms and adverse event reporting, adjudicated by independent video review. Timepoint: From intraoperative period through 6-month follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Intraoperative arterial injury, recorded in operation note and confirmed on video review. Timepoint: Intraoperative. 2. Post-operative cerebrospinal fluid (CSF) leak, recorded in case notes and confirmed radiologically/clinically. Timepoint: During inpatient stay and up to 6 months post-surgery. 3. Infection (including meningitis), recorded from clinical notes and microbiology results. Timepoint: Inpatient stay up to 6 months post-surgery. 4. Extent of resection measured using post-operative MRI with contrast. Timepoint: Approximately 4 months post-surgery. 5. Need for subsequent intervention for complication, documented from case notes. Timepoint: Within 30 days post-surgery. 6. Mortality: survival status recorded from hospital records. Timepoint: At 6 months post-surgery. Endocrine outcomes: 7. New hypopituitarism, assessed by pituitary hormone panel (cortisol, prolactin, FT4, TSH, IGF-1, GH, LH, FSH, testosterone). Timepoint: Post-op inpatient stay, endocrine clinic review, and 6 months. 8. Recovery of pituitary function, assessed by pituitary hormone panel (cortisol, prolactin, FT4, TSH, IGF-1, GH, LH, FSH, testosterone). Timepoint: At 6 months. 9. Remission (functioning adenomas) assessed by biochemical hormone markers. Timepoint: At 6 months. 10. Post-operative dysnatremia assessed by serum sodium monitoring. Timepoint: Inpatient stay and up to 6 months. 11. Sexual/reproductive health outcomes assessed using clinical history and endocrine profile. Timepoint: At 6 months. Ophthalmic outcomes: 12. Visual acuity measured using Snellen chart or equivalent. Timepoint: Pre-op, inpatient stay, 6 months. 13. Visual fields measured by formal perimetry. Timepoint: Pre-op, inpatient stay, 6 months. Nasal outcomes: 14. Sense of smell/taste assessed by patient self-report and clinical review. Timepoint: Inpatient stay and 6 months. Quality of life outcomes: 15. General health status measured using SF-36 questionnaire. Timepoint: Pre-operatively (twice, two weeks apa | — |
Countries
England, United Kingdom
Contacts
Public ContactJohn Hanrahan
Outcome results
None listed